CompletedPhase 2Results posted

A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

A PHASE 2 DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS/ PHARMACODYNAMICS OF PF-04360365 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS

Lead sponsor

Pfizer

Asset

PF-04360365

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)•Brain Magnetic Resonance Imaging (MRI) Abnormalities•Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2009-011172-30

Org study IDA9951007

NCT IDNCT00945672

Secondary IDPIB/PET IMAGINGAlias Study Number

Timeline

Milestones

Study first posted2009-07-24estimated

Study start2009-08-06actual

Primary completion2011-06-01actual

Study completion2011-06-01actual

Last update posted2024-04-19actual

Results first posted2024-04-19actual

Assets

Drug assets

PF-04360365

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Males or females of non childbearing potential, age > or = 50.

•Diagnosis of probable Alzheimer's disease, consistent with criteria from both:

-National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA).

-Diagnostic and Statistical Manual of Mental Disorders (DSM IV).

•Mini-mental status exam score of 16-26 inclusive.

•Rosen-Modified Hachinski Ischemia Score of < or = 4

Exclusion criteria

•Diagnosis or history of other demential or neurodegenerative disorders.

•Diagnosis or history of clinically significant cerebrovascular disease.

•Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities.

•History of autoimmune disorders.

•History of allergic or anaphylactic reactions.

Endpoints (122)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Amyloid biomarkers

Fluid / digital biomarkers

Global cognition

Neuroimaging

Function / daily living

Tau biomarkers

Other (unclassified)

Global cognition

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18

Time frame:Baseline, Month 3, 6, 9, 13, 18

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13

Time frame:Baseline, Month 13

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18

Time frame:Baseline, Month 3, 6, 9, 13, 18

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)Baselinen=12 Participants	18.6	8.71
Change at Month 3n=12 Participants	0.5	8.31
Change at Month 6n=12 Participants	2.3	5.96
Change at Month 9n=11 Participants	2.4	9.29
Change at Month 13n=10 Participants	0.8	6.27
Change at Month 18n=11 Participants	5.4	8.43
Placebo (Cohort Q)Baselinen=6 Participants	23.5	12.56
Change at Month 3n=5 Participants	1.9	5.43
Change at Month 6n=6 Participants	2.3	6.11
Change at Month 9n=6 Participants	2.8	11.00
Change at Month 13n=4 Participants	0.9	6.42
Change at Month 18n=4 Participants	-3.7	0.72
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Baselinen=12 Participants	18.2	6.57
Change at Month 3n=12 Participants	-2.6	5.33
Change at Month 6n=12 Participants	-0.6	7.32
Change at Month 9n=11 Participants	1.6	6.11
Change at Month 13n=11 Participants	3.8	8.04
Change at Month 18n=12 Participants	5.9	10.47
Placebo (Cohort M)Baselinen=6 Participants	20.1	9.79
Change at Month 3n=6 Participants	-2.4	3.72
Change at Month 6n=5 Participants	-4.3	3.58
Change at Month 9n=4 Participants	-0.5	6.34
Change at Month 13n=3 Participants	-2.0	2.91
Change at Month 18n=3 Participants	5.7	5.51

Least Squares (LS) Mean Difference0.1190% CI-6.49 - 6.71p0.9779Mixed Models Analysis

Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference0.5890% CI-5.79 - 6.94p0.8801Mixed Models Analysis

Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference0.2890% CI-6.13 - 6.70p0.9412Mixed Models Analysis

Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference-1.3690% CI-8.38 - 5.66p0.7486Mixed Models Analysis

Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

L S Mean Difference8.1890% CI1.24 - 15.12p0.0534Mixed Models Analysis

Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

L S Mean Difference0.0190% CI-6.29 - 6.31p0.9980Mixed Models Analysis

Month 3: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

L S Mean Difference3.3590% CI-3.25 - 9.94p0.4004Mixed Models Analysis

Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

L S Mean Difference1.8190% CI-5.20 - 8.82p0.6685Mixed Models Analysis

Month 9: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

L S Mean Difference4.7490% CI-2.77 - 12.25p0.2968Mixed Models Analysis

Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

L S Mean Difference-1.3190% CI-8.77 - 6.16p0.7720Mixed Models Analysis

Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13

Time frame:Baseline, Month 13

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)Baselinen=12 Participants	21.8	3.81
Change at Month 13n=12 Participants	-1.5	2.50
Placebo (Cohort Q)Baselinen=6 Participants	20.3	3.27
Change at Month 13n=6 Participants	-3.3	6.68
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Baselinen=12 Participants	20.7	3.68
Change at Month 13n=12 Participants	-1.3	3.57
Placebo (Cohort M)Baselinen=6 Participants	21.7	4.84
Change at Month 13n=4 Participants	-2.8	3.20

LS Mean Difference1.3590% CI-1.90 - 4.60p0.4855ANCOVA

Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.

LS Mean Difference1.4590% CI-2.27 - 5.16p0.5132ANCOVA

Month 13: Analysis of covariance (ANCOVA) with cohort by treatment interaction as fixed effect and baseline scores as covariate.

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18

Time frame:Baseline, Month 6, 13, 18

change from baseline, improvement

Secondary/registry result

Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18

Time frame:Baseline, Month 6, 13, 18

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)Baselinen=12 Participants	90.2	12.58
Change at Month 6n=12 Participants	-2.1	4.51
Change at Month 13n=12 Participants	-9.5	16.63
Change at Month 18n=12 Participants	-19.9	21.43
Placebo (Cohort Q)Baselinen=6 Participants	85.6	15.35
Change at Month 6n=6 Participants	-3.4	9.19
Change at Month 13n=6 Participants	-20.1	22.81
Change at Month 18n=6 Participants	-28.0	12.04
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Baselinen=12 Participants	75.4	17.85
Change at Month 6n=12 Participants	-1.2	13.06
Change at Month 13n=12 Participants	-8.5	23.78
Change at Month 18n=11 Participants	-17.1	24.18
Placebo (Cohort M)Baselinen=6 Participants	87.3	19.09
Change at Month 6n=6 Participants	-1.0	8.33
Change at Month 13n=5 Participants	-10.4	19.10
Change at Month 18n=5 Participants	-14.7	14.54

LS Mean Difference2.0090% CI-12.68 - 16.69p0.8205Mixed Models Analysis

Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference11.3790% CI-3.31 - 26.06p0.2007Mixed Models Analysis

Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference8.9090% CI-5.78 - 23.59p0.3152Mixed Models Analysis

Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference-2.2090% CI-17.18 - 12.79p0.8071Mixed Models Analysis

Month 6: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference-0.1090% CI-15.72 - 15.52p0.9918Mixed Models Analysis

Month 13: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

LS Mean Difference-3.0190% CI-18.73 - 12.70p0.7498Mixed Models Analysis

Month 18: Mixed model repeated measures (MMRM) analysis with cohort, treatment by time interaction as fixed effects and baseline as covariate.

Amyloid biomarkers

28 endpoints

Primary/protocol endpoint

Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M

Time frame:Baseline, Month 13

change from baseline, improvement

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0

Time frame:0 hour on Day 0 (Day prior to dosing)

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M

Time frame:216 hours post-dose on Day 1

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M

Time frame:456 hours post-dose on Day 1

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M

Time frame:0 hour (pre-dose) on Day 30

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q

Time frame:936 hours post-dose on Day 1 (Samples taken on Day 40)

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q

Time frame:1176 hours post-dose on Day 1 (Samples taken on Day 50)

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q

Time frame:1416 hours post-dose on Day 1 (Samples taken on Day 60)

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q

Time frame:0 hour (pre-dose) on Day 90

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180

Time frame:0 hour (pre-dose) on Day 180

concentration, descriptive

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360

Time frame:0 hour (pre-dose) on Day 360

concentration, descriptive

Primary/registry result

Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M

Time frame:Baseline, Month 13

change from baseline, improvement

Posted result

Group	Value (mean), Standard update value ratio	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Baseline: Frontal Cortexn=12 Participants	2.781	0.6769
Baseline: Parietal Cortexn=12 Participants	2.480	0.5175
Baseline: Lateral Temporal Cortexn=12 Participants	2.492	0.4945
Baseline: Occipital Cortexn=12 Participants	2.085	0.4064
Baseline: Cerebellumn=12 Participants	1.000	0.0000
Baseline: Striatumn=12 Participants	2.325	0.4351
Baseline: Anterior Cingulumn=12 Participants	2.723	0.6085
Baseline: Temporal Medialn=12 Participants	1.557	0.1693
Baseline: Posterior Cingulumn=12 Participants	2.866	0.5547
Baseline: Ponsn=12 Participants	2.042	0.3195
Baseline: Subcortical White Mattern=12 Participants	2.315	0.3442
Change at Month 13: Frontal Cortexn=12 Participants	-0.092	0.3081
Change at Month 13: Parietal Cortexn=12 Participants	-0.030	0.2039
Change at Month 13: Lateral Temporal Cortexn=12 Participants	-0.056	0.2485
Change at Month 13: Occipital Cortexn=12 Participants	-0.066	0.2027
Change at Month 13: Cerebellumn=12 Participants	0.000	0.0000
Change at Month 13: Striatumn=12 Participants	-0.047	0.1602
Change at Month 13: Anterior Cingulumn=12 Participants	-0.103	0.2397
Change at Month 13: Temporal Medialn=12 Participants	-0.009	0.0960
Change at Month 13: Posterior Cingulumn=12 Participants	-0.065	0.2770
Change at Month 13: Ponsn=12 Participants	-0.026	0.2034
Change at Month 13: Subcortical White Mattern=12 Participants	-0.083	0.2047
Placebo (Cohort M)Baseline: Frontal Cortexn=6 Participants	2.835	0.3775
Baseline: Parietal Cortexn=6 Participants	2.647	0.4020
Baseline: Lateral Temporal Cortexn=6 Participants	2.626	0.3327
Baseline: Occipital Cortexn=6 Participants	1.994	0.2066
Baseline: Cerebellumn=6 Participants	1.000	0.0000
Baseline: Striatumn=6 Participants	2.440	0.3468
Baseline: Anterior Cingulumn=6 Participants	2.845	0.3109
Baseline: Temporal Medialn=6 Participants	1.615	0.1334
Baseline: Posterior Cingulumn=6 Participants	2.927	0.3624
Baseline: Ponsn=6 Participants	2.091	0.3871
Baseline: Subcortical White Mattern=6 Participants	2.407	0.3180
Change at Month 13: Frontal Cortexn=6 Participants	-0.096	0.3243
Change at Month 13: Parietal Cortexn=6 Participants	-0.113	0.3309
Change at Month 13: Lateral Temporal Cortexn=6 Participants	-0.094	0.2956
Change at Month 13: Occipital Cortexn=6 Participants	0.047	0.2409
Change at Month 13: Cerebellumn=6 Participants	0.000	0.0000
Change at Month 13: Striatumn=6 Participants	-0.091	0.2568
Change at Month 13: Anterior Cingulumn=6 Participants	-0.068	0.3245
Change at Month 13: Temporal Medialn=6 Participants	-0.025	0.2255
Change at Month 13: Posterior Cingulumn=6 Participants	-0.103	0.3539
Change at Month 13: Ponsn=6 Participants	-0.013	0.2181
Change at Month 13: Subcortical White Mattern=6 Participants	-0.024	0.2781

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0

Time frame:0 hour on Day 0 (Day prior to dosing)

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter (pg/mL)	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)A-beta 1-xn=12 Participants	31150.00	9063.66
A-beta 1-40n=12 Participants	15794.17	7569.38
A-beta 1-42n=12 Participants	1003.75	358.30
Placebo (Cohort Q)A-beta 1-xn=6 Participants	28533.33	5269.41
A-beta 1-40n=6 Participants	13296.67	2428.35
A-beta 1-42n=6 Participants	882.00	185.95
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)A-beta 1-xn=12 Participants	30497.50	16885.00
A-beta 1-40n=12 Participants	11688.33	3813.40
A-beta 1-42n=12 Participants	758.67	204.65
Placebo (Cohort M)A-beta 1-xn=6 Participants	28500.00	8696.44
A-beta 1-40n=6 Participants	12215.00	2674.13
A-beta 1-42n=6 Participants	870.00	270.25

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M

Time frame:216 hours post-dose on Day 1

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)A-beta 1-xn=4 Participants	22.32	17.55
A-beta 1-40n=4 Participants	9.24	44.06
A-beta 1-42n=4 Participants	-0.46	14.59
Placebo (Cohort M)A-beta 1-xn=1 Participants	-21.21	NA
A-beta 1-40n=1 Participants	1.43	NA
A-beta 1-42n=1 Participants	-3.78	NA

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M

Time frame:456 hours post-dose on Day 1

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)A-beta 1-xn=4 Participants	-2.38	14.01
A-beta 1-40n=4 Participants	4.23	25.16
A-beta 1-42n=4 Participants	8.14	31.37
Placebo (Cohort M)A-beta 1-xn=1 Participants	-5.95	NA
A-beta 1-40n=1 Participants	-8.75	NA
A-beta 1-42n=1 Participants	-24.57	NA

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M

Time frame:0 hour (pre-dose) on Day 30

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)A-beta 1-xn=4 Participants	0.80	31.57
A-beta 1-40n=4 Participants	43.33	20.67
A-beta 1-42n=4 Participants	14.15	17.45
Placebo (Cohort M)A-beta 1-xn=2 Participants	-0.79	30.68
A-beta 1-40n=2 Participants	-17.07	19.05
A-beta 1-42n=2 Participants	-13.98	12.48

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q

Time frame:936 hours post-dose on Day 1 (Samples taken on Day 40)

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)A-beta 1-xn=4 Participants	16.78	9.69
A-beta 1-40n=4 Participants	26.77	16.01
A-beta 1-42n=4 Participants	17.30	14.03
Placebo (Cohort Q)A-beta 1-xn=2 Participants	5.05	3.71
A-beta 1-40n=2 Participants	160.62	51.13
A-beta 1-42n=2 Participants	-7.40	13.74

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q

Time frame:1176 hours post-dose on Day 1 (Samples taken on Day 50)

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)A-beta 1-xn=4 Participants	12.35	11.45
A-beta 1-40n=4 Participants	-17.98	37.02
A-beta 1-42n=4 Participants	2.32	16.51
Placebo (Cohort Q)A-beta 1-xn=2 Participants	-1.60	9.02
A-beta 1-40n=2 Participants	-6.67	9.43
A-beta 1-42n=2 Participants	-3.36	18.68

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q

Time frame:1416 hours post-dose on Day 1 (Samples taken on Day 60)

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)A-beta 1-xn=4 Participants	9.62	6.51
A-beta 1-40n=4 Participants	27.85	35.55
A-beta 1-42n=4 Participants	9.52	14.31
Placebo (Cohort Q)A-beta 1-xn=2 Participants	0.04	1.33
A-beta 1-40n=2 Participants	-5.61	0.44
A-beta 1-42n=2 Participants	-12.08	2.95

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q

Time frame:0 hour (pre-dose) on Day 90

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)A-beta 1-xn=4 Participants	-0.51	8.96
A-beta 1-40n=4 Participants	27.67	40.65
A-beta 1-42n=4 Participants	-15.62	18.01
Placebo (Cohort Q)A-beta 1-xn=1 Participants	-15.57	NA
A-beta 1-40n=1 Participants	-23.23	NA
A-beta 1-42n=1 Participants	-38.65	NA

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180

Time frame:0 hour (pre-dose) on Day 180

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)A-beta 1-xn=8 Participants	-37.94	9.81
A-beta 1-40n=8 Participants	-60.93	13.99
A-beta 1-42n=7 Participants	18.57	19.99
Placebo (Cohort Q)A-beta 1-xn=4 Participants	-44.49	10.99
A-beta 1-40n=4 Participants	-60.42	7.98
A-beta 1-42n=4 Participants	-4.18	22.66
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)A-beta 1-xn=12 Participants	13.91	21.25
A-beta 1-40n=12 Participants	179.14	121.44
A-beta 1-42n=12 Participants	75.58	45.47
Placebo (Cohort M)A-beta 1-xn=5 Participants	-0.57	23.16
A-beta 1-40n=5 Participants	147.17	126.47
A-beta 1-42n=5 Participants	-15.77	34.09

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360

Time frame:0 hour (pre-dose) on Day 360

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)A-beta 1-xn=12 Participants	-16.70	22.23
A-beta 1-40n=9 Participants	98.33	133.77
A-beta 1-42n=12 Participants	-26.70	40.32
Placebo (Cohort Q)A-beta 1-xn=5 Participants	-30.01	11.85
A-beta 1-40n=4 Participants	35.60	122.29
A-beta 1-42n=4 Participants	-40.24	14.77
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)A-beta 1-xn=12 Participants	-27.69	28.11
A-beta 1-40n=12 Participants	3.07	69.15
A-beta 1-42n=12 Participants	49.15	54.18
Placebo (Cohort M)A-beta 1-xn=5 Participants	-42.16	17.77
A-beta 1-40n=5 Participants	56.66	90.93
A-beta 1-42n=5 Participants	-27.46	11.27

Secondary/protocol endpoint

Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)

Time frame:Cohort M&Q: 0 hour(hr) & 0.25 hrs post dose (pd) on Day (D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936,1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D 60, 0 hr & 0.25 hrs pd on D 30,120,150,210,240,300,330

concentration, descriptive

Secondary/protocol endpoint

Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)

Time frame:Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390,540; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330

concentration, descriptive

Secondary/protocol endpoint

Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)

Time frame:Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330

concentration, descriptive

Secondary/registry result

Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)0 Hour Day 1n=12 Participants	128.92	129.49
0.25 Hours Day 1n=10 Participants	454.50	214.42
0 Hour Day 40n=4 Participants	97225.00	18871.56
0 Hour Day 50n=3 Participants	104833.33	15671.10
0 Hour Day 60n=3 Participants	112100.00	14255.88
0 Hour Day 90n=8 Participants	69650.00	19280.49
0.25 Hours Day 90n=8 Participants	56450.00	20203.96
0 Hour Day 180n=3 Participants	76533.33	11019.23
0.25 Hours Day 180n=4 Participants	67000.00	12926.20
0 Hour Day 270n=8 Participants	72775.00	16698.40
0.25 Hours Day 270n=1 Participants	74000.00	NA
0 Hour Day 360n=6 Participants	81483.33	11155.34
0.25 Hours Day 360n=8 Participants	63462.50	25395.10
Placebo (Cohort Q)0 Hour Day 1n=6 Participants	136.00	107.16
0.25 Hours Day 1n=6 Participants	191.17	97.01
0 Hour Day 40n=2 Participants	266.00	29.70
0 Hour Day 50n=2 Participants	299.00	50.91
0 Hour Day 60n=2 Participants	455.50	78.49
0 Hour Day 90n=4 Participants	327.25	162.98
0.25 Hours Day 90n=4 Participants	349.50	180.97
0 Hour Day 180n=1 Participants	459.00	NA
0.25 Hours Day 180n=1 Participants	399.00	NA
0 Hour Day 270n=3 Participants	353.33	127.41
0.25 Hours Day 270n=3 Participants	286.67	105.04
0 Hour Day 360n=3 Participants	433.33	128.94
0 Hour Day 390n=2 Participants	90.00	127.28
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)0 Hour Day 1n=12 Participants	190.67	133.79
0.25 Hours Day 1n=12 Participants	551.33	344.39
0 Hour Day 10n=4 Participants	86025.00	17717.48
0 Hour Day 20n=3 Participants	97633.33	16223.54
0 Hour Day 30n=7 Participants	112571.43	20332.79
0.25 Hours Day 30n=5 Participants	90900.00	21793.12
0 Hour Day 60n=6 Participants	114650.00	15162.55
0.25 Hours Day 60n=5 Participants	115600.00	8763.56
0 Hour Day 90n=3 Participants	107400.00	14208.45
0.25 Hours Day 90n=3 Participants	94166.67	18315.11
0 Hour Day 120n=5 Participants	114440.00	20378.13
0.25 Hours Day 120n=4 Participants	99425.00	18753.38
0 Hour Day 150n=5 Participants	112920.00	18388.37
0.25 Hours Day 150n=6 Participants	100266.67	28577.87
0 Hour Day 180n=6 Participants	123333.33	14066.51
0.25 Hours Day 180n=6 Participants	106500.00	20753.31
0 Hour Day 210n=5 Participants	120400.00	34173.09
0.25 Hours Day 210n=4 Participants	103075.00	18902.09
0 Hour Day 240n=6 Participants	115700.00	22991.74
0.25 Hours Day 240n=5 Participants	101700.00	25123.69
0 Hour Day 270n=6 Participants	114500.00	10329.57
0.25 Hours Day 270n=6 Participants	104400.00	23665.25
0 Hour Day 300n=4 Participants	112750.00	6075.91
0.25 Hours Day 300n=3 Participants	101000.00	19672.32
0 Hour Day 330n=5 Participants	119400.00	31413.37
0.25 Hours Day 330n=4 Participants	117000.00	19899.75
0 Hour Day 360n=4 Participants	115925.00	21198.01
0.25 Hours Day 360n=5 Participants	111980.00	19276.98
0 Hour Day 390n=1 Participants	140000.00	NA
Placebo (Cohort M)0 Hour Day 1n=6 Participants	167.17	169.34
0.25 Hours Day 1n=5 Participants	196.00	152.32
0 Hour Day 10n=1 Participants	171.00	NA
0 Hour Day 20n=2 Participants	268.50	55.86
0 Hour Day 30n=4 Participants	273.25	125.07
0.25 Hours Day 30n=4 Participants	288.25	124.20
0 Hour Day 60n=3 Participants	234.33	33.98
0.25 Hours Day 60n=1 Participants	226.00	NA
0 Hour Day 90n=4 Participants	340.75	183.38
0.25 Hours Day 90n=4 Participants	381.00	171.66
0 Hour Day 120n=4 Participants	373.50	181.21
0.25 Hours Day 120n=1 Participants	249.00	NA
0 Hour Day 150n=3 Participants	276.67	292.63
0.25 Hours Day 150n=3 Participants	336.33	233.34
0 Hour Day 180n=3 Participants	280.33	256.41
0.25 Hours Day 180n=3 Participants	278.00	297.64
0 Hour Day 210n=3 Participants	265.33	95.93
0.25 Hours Day 210n=1 Participants	570.00	NA
0 Hour Day 240n=3 Participants	334.00	430.61
0.25 Hours Day 240n=3 Participants	303.33	339.46
0 Hour Day 270n=3 Participants	304.67	358.70
0.25 Hours Day 270n=2 Participants	142.00	200.82
0 Hour Day 300n=3 Participants	230.67	230.00
0.25 Hours Day 300n=1 Participants	0.00	NA
0 Hour Day 330n=3 Participants	283.33	251.46
0.25 Hours Day 330n=3 Participants	256.33	222.01
0 Hour Day 360n=5 Participants	267.60	188.12
0.25 Hours Day 360n=5 Participants	247.80	226.73

Secondary/registry result

Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)0 Hour Day 1n=9 Participants	219.44	163.52
0.25 Hours Day 1n=8 Participants	618.00	73.00
0 Hour Day 40n=3 Participants	65100.00	13163.97
0 Hour Day 50n=4 Participants	105075.00	26779.77
0 Hour Day 60n=4 Participants	106625.00	27207.15
0 Hour Day 90n=9 Participants	54244.44	12650.31
0.25 Hours Day 90n=10 Participants	50280.00	15748.78
0 Hour Day 180n=12 Participants	67566.67	20145.35
0.25 Hours Day 180n=11 Participants	62000.00	20374.15
0 Hour Day 270n=8 Participants	89062.50	36384.45
0.25 Hours Day 270n=2 Participants	95550.00	43062.80
0 Hour Day 360n=7 Participants	77442.86	38989.14
0.25 Hours Day 360n=7 Participants	70228.57	33633.25
Placebo (Cohort Q)0 Hour Day 1n=5 Participants	136.60	125.87
0.25 Hours Day 1n=3 Participants	163.67	141.99
0 Hour Day 60n=2 Participants	269.50	125.16
0 Hour Day 90n=3 Participants	225.67	61.01
0.25 Hours Day 90n=3 Participants	174.67	163.48
0 Hour Day 180n=6 Participants	228.17	51.76
0.25 Hours Day 180n=6 Participants	211.17	107.37
0 Hour Day 270n=6 Participants	607.17	400.20
0.25 Hours Day 270n=4 Participants	735.50	481.31
0 Hour Day 360n=6 Participants	1450.83	2634.66
0.25 Hours Day 360n=4 Participants	3287.50	2585.41
0 Hour Day 390n=3 Participants	673.67	629.67
0 Hour Day 540n=4 Participants	369.00	71.73
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)0 Hour Day 1n=10 Participants	166.20	102.44
0.25 Hours Day 1n=12 Participants	530.33	215.49
0 Hour Day 10n=3 Participants	71233.33	2345.92
0 Hour Day 20n=4 Participants	97725.00	29818.05
0 Hour Day 30n=11 Participants	87045.45	17785.41
0.25 Hours Day 30n=10 Participants	93720.00	14011.17
0 Hour Day 60n=12 Participants	86383.33	22189.79
0.25 Hours Day 60n=10 Participants	91280.00	25493.13
0 Hour Day 90n=12 Participants	92341.67	31491.97
0.25 Hours Day 90n=10 Participants	73400.00	29078.63
0 Hour Day 120n=12 Participants	88850.00	36003.07
0.25 Hours Day 120n=10 Participants	78230.00	32535.90
0 Hour Day 150n=9 Participants	113788.89	36944.09
0.25 Hours Day 150n=8 Participants	107850.00	44298.95
0 Hour Day 180n=7 Participants	136800.00	57309.80
0.25 Hours Day 180n=6 Participants	154666.67	67813.47
0 Hour Day 210n=7 Participants	154142.86	68875.32
0.25 Hours Day 210n=6 Participants	139066.67	62146.49
0 Hour Day 240n=7 Participants	156714.29	69257.28
0.25 Hours Day 240n=5 Participants	128000.00	43069.71
0 Hour Day 270n=6 Participants	113766.67	25223.53
0.25 Hours Day 270n=6 Participants	150333.33	43738.62
0 Hour Day 300n=6 Participants	130000.00	30880.41
0.25 Hours Day 300n=5 Participants	138780.00	72485.46
0 Hour Day 330n=7 Participants	100285.71	51435.12
0.25 Hours Day 330n=3 Participants	103666.67	81733.31
0 Hour Day 360n=8 Participants	114612.50	17519.82
0.25 Hours Day 360n=4 Participants	131000.00	33724.37
Placebo (Cohort M)0 Hour Day 1n=5 Participants	157.20	152.25
0.25 Hours Day 1n=5 Participants	190.40	26.29
0 Hour Day 20n=2 Participants	197.50	28.99
0 Hour Day 30n=6 Participants	216.00	39.09
0.25 Hours Day 30n=6 Participants	275.67	120.27
0 Hour Day 60n=6 Participants	137.67	107.77
0.25 Hours Day 60n=4 Participants	197.00	133.61
0 Hour Day 90n=6 Participants	179.17	94.84
0.25 Hours Day 90n=6 Participants	206.67	74.95
0 Hour Day 120n=6 Participants	243.83	54.15
0.25 Hours Day 120n=3 Participants	181.00	158.09
0 Hour Day 150n=5 Participants	1341.00	1913.05
0.25 Hours Day 150n=4 Participants	1422.00	1655.19
0 Hour Day 180n=6 Participants	623.50	505.02
0.25 Hours Day 180n=4 Participants	796.50	502.64
0 Hour Day 210n=2 Participants	696.50	598.92
0.25 Hours Day 210n=3 Participants	663.67	413.37
0 Hour Day 240n=4 Participants	616.25	292.13
0.25 Hours Day 240n=4 Participants	744.50	533.68
0 Hour Day 270n=3 Participants	473.67	61.27
0.25 Hours Day 270n=4 Participants	540.50	382.69
0 Hour Day 300n=6 Participants	607.50	194.00
0.25 Hours Day 300n=3 Participants	609.67	204.23
0 Hour Day 330n=5 Participants	1251.40	1767.97
0.25 Hours Day 330n=4 Participants	1545.75	1545.67
0 Hour Day 360n=3 Participants	1486.33	1673.10
0.25 Hours Day 360n=5 Participants	766.00	685.10
0 Hour Day 390n=2 Participants	330.00	11.31
0 Hour Day 540n=4 Participants	311.00	37.26

Secondary/registry result

Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)0 Hour Day 1n=12 Participants	4.62	15.99
0.25 Hours Day 1n=10 Participants	5.76	18.21
0 Hour Day 40n=4 Participants	0.00	0.00
0 Hour Day 50n=4 Participants	0.00	0.00
0 Hour Day 60n=4 Participants	18.58	37.15
0 Hour Day 90n=12 Participants	6.18	16.04
0.25 Hours Day 90n=11 Participants	5.22	17.31
0 Hour Day 180n=12 Participants	6.52	15.24
0.25 Hours Day 180n=11 Participants	3.69	12.24
0 Hour Day 270n=11 Participants	0.00	0.00
0.25 Hours Day 270n=7 Participants	0.00	0.00
0 Hour Day 360n=12 Participants	0.00	0.00
0.25 Hours Day 360n=11 Participants	0.00	0.00
0 Hour Day 390n=9 Participants	0.00	0.00
Placebo (Cohort Q)0 Hour Day 1n=6 Participants	85.23	133.09
0.25 Hours Day 1n=6 Participants	73.23	109.30
0 Hour Day 40n=2 Participants	191.50	270.82
0 Hour Day 50n=2 Participants	46.15	65.27
0 Hour Day 60n=2 Participants	0.00	0.00
0 Hour Day 90n=6 Participants	89.73	138.77
0.25 Hours Day 90n=6 Participants	87.67	136.60
0 Hour Day 180n=6 Participants	77.83	131.64
0.25 Hours Day 180n=6 Participants	78.83	124.29
0 Hour Day 270n=6 Participants	96.83	168.84
0.25 Hours Day 270n=6 Participants	79.33	141.85
0 Hour Day 360n=6 Participants	98.33	165.43
0.25 Hours Day 360n=6 Participants	130.17	265.68
0 Hour Day 390n=5 Participants	107.40	240.15
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)0 Hour Day 1n=12 Participants	41.05	135.84
0.25 Hours Day 1n=12 Participants	34.33	112.18
0 Hour Day 10n=4 Participants	0.00	0.00
0 Hour Day 20n=4 Participants	141.25	282.50
0 Hour Day 30n=11 Participants	45.15	139.88
0.25 Hours Day 30n=10 Participants	47.24	140.36
0 Hour Day 60n=12 Participants	44.86	135.13
0.25 Hours Day 60n=10 Participants	37.12	109.15
0 Hour Day 90n=12 Participants	43.19	129.12
0.25 Hours Day 90n=10 Participants	52.09	152.20
0 Hour Day 120n=12 Participants	45.19	134.60
0.25 Hours Day 120n=10 Participants	44.29	124.45
0 Hour Day 150n=12 Participants	42.48	129.48
0.25 Hours Day 150n=11 Participants	45.51	132.38
0 Hour Day 180n=12 Participants	16.67	57.74
0.25 Hours Day 180n=10 Participants	14.70	46.49
0 Hour Day 210n=12 Participants	3.96	13.71
0.25 Hours Day 210n=12 Participants	21.08	73.03
0 Hour Day 240n=12 Participants	3.18	11.00
0.25 Hours Day 240n=11 Participants	38.73	128.44
0 Hour Day 270n=12 Participants	22.50	77.94
0.25 Hours Day 270n=11 Participants	1.85	6.15
0 Hour Day 300n=11 Participants	38.91	129.05
0.25 Hours Day 300n=10 Participants	14.60	46.17
0 Hour Day 330n=12 Participants	0.00	0.00
0.25 Hours Day 330n=10 Participants	0.00	0.00
0 Hour Day 360n=12 Participants	44.59	146.44
0.25 Hours Day 360n=11 Participants	31.64	104.93
0 Hour Day 390n=12 Participants	12.17	42.15
Placebo (Cohort M)0 Hour Day 1n=6 Participants	11.82	28.94
0.25 Hours Day 1n=5 Participants	15.96	22.68
0 Hour Day 10n=1 Participants	30.00	NA
0 Hour Day 20n=2 Participants	0.00	0.00
0 Hour Day 30n=6 Participants	17.48	30.18
0.25 Hours Day 30n=6 Participants	18.72	33.96
0 Hour Day 60n=6 Participants	17.43	29.00
0.25 Hours Day 60n=4 Participants	7.80	15.60
0 Hour Day 90n=6 Participants	17.52	31.33
0.25 Hours Day 90n=6 Participants	14.77	24.91
0 Hour Day 120n=6 Participants	14.90	25.03
0.25 Hours Day 120n=3 Participants	17.40	30.14
0 Hour Day 150n=6 Participants	4.28	10.49
0.25 Hours Day 150n=6 Participants	4.67	11.43
0 Hour Day 180n=6 Participants	0.00	0.00
0.25 Hours Day 180n=6 Participants	0.00	0.00
0 Hour Day 210n=5 Participants	0.00	0.00
0.25 Hours Day 210n=3 Participants	0.00	0.00
0 Hour Day 240n=5 Participants	0.00	0.00
0.25 Hours Day 240n=5 Participants	0.00	0.00
0 Hour Day 270n=5 Participants	0.00	0.00
0.25 Hours Day 270n=4 Participants	0.00	0.00
0 Hour Day 300n=6 Participants	0.00	0.00
0.25 Hours Day 300n=3 Participants	0.00	0.00
0 Hour Day 330n=5 Participants	0.00	0.00
0.25 Hours Day 330n=5 Participants	0.00	0.00
0 Hour Day 360n=5 Participants	0.00	0.00
0.25 Hours Day 360n=5 Participants	0.00	0.00
0 Hour Day 390n=4 Participants	0.00	0.00

Tau biomarkers

2 endpoints

Other/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins

Time frame:Cohort M&Q: Pre dose (0 hr) on Day 0, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30

concentration, descriptive

Other_pre_specified/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins

concentration, descriptive

Posted result

Group	Value (mean), pg/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)0 Hour Day 0: taun=12 Participants	185.70	58.11
0 Hour Day 40: taun=4 Participants	-21.13	9.99
0 Hour Day 50: taun=4 Participants	7.70	24.02
0 Hour Day 60: taun=4 Participants	15.90	22.71
0 Hour Day 90: taun=4 Participants	-6.88	22.64
0 Hour Day 180: taun=8 Participants	-15.76	18.49
0 Hour Day 360: taun=10 Participants	1.37	22.13
0 Hour Day 0: p-taun=12 Participants	67.19	18.05
0 Hour Day 40: p-taun=4 Participants	21.41	27.96
0 Hour Day 50: p-taun=4 Participants	39.51	63.57
0 Hour Day 60: p-taun=4 Participants	2.28	19.79
0 Hour Day 90: p-taun=4 Participants	16.04	24.13
0 Hour Day 180: p-taun=8 Participants	-8.31	29.96
0 Hour Day 360: p-taun=12 Participants	4.29	38.32
Placebo (Cohort Q)0 Hour Day 0: taun=6 Participants	194.00	88.75
0 Hour Day 40: taun=2 Participants	-4.07	3.13
0 Hour Day 50: taun=2 Participants	7.92	6.19
0 Hour Day 60: taun=2 Participants	-10.43	3.35
0 Hour Day 90: taun=1 Participants	-9.18	NA
0 Hour Day 180: taun=4 Participants	-37.35	13.67
0 Hour Day 360: taun=6 Participants	-2.07	19.78
0 Hour Day 0: p-taun=6 Participants	65.77	20.21
0 Hour Day 40: p-taun=2 Participants	6.53	1.72
0 Hour Day 50: p-taun=2 Participants	62.96	100.89
0 Hour Day 60: p-taun=2 Participants	-3.10	10.26
0 Hour Day 90: p-taun=1 Participants	-3.95	NA
0 Hour Day 180: p-taun=4 Participants	-7.45	43.56
0 Hour Day 360: p-taun=6 Participants	24.55	35.01
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)0 Hour Day 0: taun=12 Participants	140.93	50.96
0 Hour Day 10: taun=4 Participants	-15.09	16.44
0 Hour Day 20: taun=4 Participants	-11.67	12.82
0 Hour Day 30: taun=4 Participants	6.60	17.76
0 Hour Day 180: taun=11 Participants	-16.47	22.01
0 Hour Day 360: taun=11 Participants	-13.15	21.38
0 Hour Day 0: p-taun=12 Participants	60.27	26.26
0 Hour Day 10: p-taun=4 Participants	0.25	36.71
0 Hour Day 20: p-taun=4 Participants	24.79	73.39
0 Hour Day 30: p-taun=4 Participants	2.91	6.51
0 Hour Day 180: p-taun=12 Participants	-10.79	58.37
0 Hour Day 360: p-taun=12 Participants	8.96	68.60
Placebo (Cohort M)0 Hour Day 0: taun=6 Participants	165.83	49.77
0 Hour Day 10: taun=1 Participants	2.55	NA
0 Hour Day 20: taun=1 Participants	4.72	NA
0 Hour Day 30: taun=2 Participants	4.22	1.36
0 Hour Day 180: taun=4 Participants	8.60	7.16
0 Hour Day 360: taun=4 Participants	-9.75	9.61
0 Hour Day 0: p-taun=6 Participants	74.00	27.73
0 Hour Day 10: p-taun=1 Participants	32.52	NA
0 Hour Day 20: p-taun=1 Participants	34.55	NA
0 Hour Day 30: p-taun=2 Participants	0.92	3.82
0 Hour Day 180: p-taun=5 Participants	10.04	24.97
0 Hour Day 360: p-taun=4 Participants	-7.31	41.09

Neuroimaging

4 endpoints

Primary/protocol endpoint

Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities

Time frame:Baseline up to Month 18

change from baseline, improvement

Primary/protocol endpoint

Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)

Time frame:Baseline up to Month 18

change from baseline, improvement

Primary/registry result

Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities

Time frame:Baseline up to Month 18

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 10 mg/kg (Cohort Q)Micro Hemorrhagen=12 Participants	1	-
Othern=12 Participants	2	-
Placebo (Cohort Q)Micro Hemorrhagen=6 Participants	0	-
Othern=6 Participants	0	-
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Micro Hemorrhagen=12 Participants	1	-
Othern=12 Participants	0	-
Placebo (Cohort M)Micro Hemorrhagen=6 Participants	1	-
Othern=6 Participants	0	-

Primary/registry result

Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)

Time frame:Baseline up to Month 18

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 10 mg/kg (Cohort Q)n=12 Participants	0	-
Placebo (Cohort Q)n=6 Participants	0	-
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	0	-
Placebo (Cohort M)n=6 Participants	0	-

Fluid / digital biomarkers

26 endpoints

Primary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0

Time frame:0 hour on Day 0 (Day prior to dosing)

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M

Time frame:216 hours post dose on Day 1 (samples taken on Day 10)

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M

Time frame:456 hours post dose on Day 1 (samples taken on Day 20)

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M

Time frame:0 hour (pre-dose) on Day 30

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q

Time frame:936 hours post dose on Day 1 (samples taken on Day 40)

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q

Time frame:1176 hours post dose on Day 1 (samples taken on Day 50)

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q

Time frame:1416 hours post-dose on Day 1 (samples taken on Day 60)

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90

Time frame:0 hour (pre-dose) on Day 90

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180

Time frame:0 hour (pre-dose) on Day 180

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360

Time frame:0 hour (pre-dose) on Day 360

concentration, descriptive

Primary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0

Time frame:0 hour on Day 0 (Day prior to dosing)

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter (ng/mL)	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=11 Participants	0.00	0.00
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	0.00	0.00

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M

Time frame:216 hours post dose on Day 1 (samples taken on Day 10)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)CSFn=4 Participants	167.25	52.68
Plasman=4 Participants	77466.25	11446.87

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M

Time frame:456 hours post dose on Day 1 (samples taken on Day 20)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)CSFn=4 Participants	192.50	90.50
Plasman=4 Participants	68219.25	18837.66

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M

Time frame:0 hour (pre-dose) on Day 30

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)CSFn=4 Participants	185.33	86.53
Plasman=11 Participants	46321.00	5902.85

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q

Time frame:936 hours post dose on Day 1 (samples taken on Day 40)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)CSFn=4 Participants	121.73	35.25
Plasman=4 Participants	34794.50	4381.87

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q

Time frame:1176 hours post dose on Day 1 (samples taken on Day 50)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)CSFn=4 Participants	107.03	44.93
Plasman=4 Participants	40038.50	11862.03

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q

Time frame:1416 hours post-dose on Day 1 (samples taken on Day 60)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)CSFn=4 Participants	84.50	25.51
Plasman=3 Participants	22917.00	4432.31

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90

Time frame:0 hour (pre-dose) on Day 90

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)CSFn=4 Participants	61.15	11.76
Plasman=12 Participants	16094.08	4932.12
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Plasman=12 Participants	68110.83	12594.63

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180

Time frame:0 hour (pre-dose) on Day 180

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)CSFn=8 Participants	89.20	26.12
Plasman=12 Participants	23708.42	5039.46
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)CSFn=11 Participants	324.82	119.92
Plasman=12 Participants	76593.58	14452.02

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360

Time frame:0 hour (pre-dose) on Day 360

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)CSFn=12 Participants	68.71	27.52
Plasman=12 Participants	20347.00	8570.57
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)CSFn=12 Participants	240.19	93.38
Plasman=12 Participants	70238.33	23030.37

Other/protocol endpoint

Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360

Time frame:Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360

change from baseline, improvement

Posted result

Group	Value (mean), gram per liter (g/L)	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)Baselinen=12 Participants	0.32	0.091
Change at 0 Hour Day 40n=4 Participants	0.00	0.015
Change at 0 Hour Day 50n=4 Participants	0.00	0.031
Change at 0 Hour Day 60n=4 Participants	0.02	0.108
Change at 0 Hour Day 90n=4 Participants	-0.01	0.015
Change at 0 Hour Day 180n=8 Participants	0.04	0.088
Change at 0 Hour Day 360n=12 Participants	0.02	0.059
Placebo (Cohort Q)Baselinen=6 Participants	0.30	0.230
Change at 0 Hour Day 40n=2 Participants	0.02	0.013
Change at 0 Hour Day 50n=2 Participants	0.06	0.064
Change at 0 Hour Day 60n=2 Participants	0.07	0.080
Change at 0 Hour Day 90n=1 Participants	0.01	NA
Change at 0 Hour Day 180n=4 Participants	0.09	0.081
Change at 0 Hour Day 360n=6 Participants	0.05	0.056
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Baselinen=12 Participants	0.32	0.198
Change at 0 Hour Day 10n=4 Participants	-0.01	0.013
Change at 0 Hour Day 20n=4 Participants	0.04	0.077
Change at 0 Hour Day 30n=4 Participants	0.02	0.027
Change at 0 Hour Day 180n=12 Participants	0.02	0.029
Change at 0 Hour Day 360n=12 Participants	0.00	0.036
Placebo (Cohort M)Baselinen=6 Participants	0.22	0.050
Change at 0 Hour Day 10n=2 Participants	0.01	0.011
Change at 0 Hour Day 20n=1 Participants	0.01	NA
Change at 0 Hour Day 30n=2 Participants	0.00	0.014
Change at 0 Hour Day 180n=5 Participants	0.04	0.026
Change at 0 Hour Day 360n=5 Participants	0.02	0.017

Other_pre_specified/registry result

Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360

change from baseline, improvement

Posted result

Group	Value (mean), 10^6 cells per liter	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)Baseline: RBCn=12 Participants	30.08	83.842
Change at 0 Hour Day 40: RBCn=4 Participants	-75.75	146.227
Change at 0 Hour Day 50: RBCn=4 Participants	-4.50	9.000
Change at 0 Hour Day 60: RBCn=4 Participants	2.50	8.660
Change at 0 Hour Day 90: RBCn=4 Participants	-70.75	149.295
Change at 0 Hour Day 180: RBCn=8 Participants	72.00	191.426
Change at 0 Hour Day 360: RBCn=12 Participants	-26.67	84.610
Baseline: WBCn=12 Participants	1.34	1.310
Change at 0 Hour Day 40: WBCn=4 Participants	0.75	0.957
Change at 0 Hour Day 50: WBCn=4 Participants	0.35	1.814
Change at 0 Hour Day 60: WBCn=4 Participants	-0.48	0.618
Change at 0 Hour Day 90: WBCn=4 Participants	1.00	1.155
Change at 0 Hour Day 180: WBCn=8 Participants	-0.35	0.862
Change at 0 Hour Day 360: WBCn=12 Participants	-0.04	2.097
Placebo (Cohort Q)Baseline: RBCn=6 Participants	1.17	2.041
Change at 0 Hour Day 40: RBCn=2 Participants	0.50	0.707
Change at 0 Hour Day 50: RBCn=2 Participants	0.00	0.000
Change at 0 Hour Day 60: RBCn=2 Participants	0.00	0.000
Change at 0 Hour Day 90: RBCn=1 Participants	-1.00	NA
Change at 0 Hour Day 180: RBCn=4 Participants	1.75	2.217
Change at 0 Hour Day 360: RBCn=6 Participants	21.83	37.870
Baseline: WBCn=6 Participants	0.98	1.250
Change at 0 Hour Day 40: WBCn=2 Participants	-0.50	0.707
Change at 0 Hour Day 50: WBCn=2 Participants	-0.65	0.919
Change at 0 Hour Day 60: WBCn=2 Participants	0.30	0.424
Change at 0 Hour Day 90: WBCn=1 Participants	-1.00	NA
Change at 0 Hour Day 180: WBCn=4 Participants	-0.33	1.087
Change at 0 Hour Day 360: WBCn=6 Participants	-0.48	0.801
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Baseline: RBCn=12 Participants	2.58	2.392
Change at 0 Hour Day 10: RBCn=4 Participants	-0.25	0.500
Change at 0 Hour Day 20: RBCn=4 Participants	80.50	141.576
Change at 0 Hour Day 30: RBCn=4 Participants	12.75	25.513
Change at 0 Hour Day 180: RBCn=12 Participants	6.25	15.516
Change at 0 Hour Day 360: RBCn=12 Participants	26.67	74.644
Baseline: WBCn=12 Participants	1.47	1.798
Change at 0 Hour Day 10: WBCn=4 Participants	0.50	2.517
Change at 0 Hour Day 20: WBCn=4 Participants	0.50	1.000
Change at 0 Hour Day 30: WBCn=4 Participants	0.00	0.000
Change at 0 Hour Day 180: WBCn=12 Participants	0.06	0.876
Change at 0 Hour Day 360: WBCn=12 Participants	0.22	0.944
Placebo (Cohort M)Baseline: RBCn=6 Participants	8.17	12.287
Change at 0 Hour Day 10: RBCn=2 Participants	67.50	95.459
Change at 0 Hour Day 20: RBCn=1 Participants	-18.00	NA
Change at 0 Hour Day 30: RBCn=2 Participants	1.50	2.121
Change at 0 Hour Day 180: RBCn=5 Participants	24.60	62.528
Change at 0 Hour Day 360: RBCn=5 Participants	-6.80	9.960
Baseline: WBCn=6 Participants	1.42	1.563
Change at 0 Hour Day 10: WBCn=2 Participants	0.00	0.000
Change at 0 Hour Day 20: WBCn=1 Participants	0.00	NA
Change at 0 Hour Day 30: WBCn=2 Participants	-0.30	0.424
Change at 0 Hour Day 180: WBCn=5 Participants	0.14	0.699
Change at 0 Hour Day 360: WBCn=5 Participants	0.14	1.182

Other_pre_specified/registry result

Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360

change from baseline, improvement

Posted result

Group	Value (mean), millimole per liter (mmol/L)	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)Baselinen=12 Participants	3.47	0.267
Change at 0 Hour Day 40n=4 Participants	-0.10	0.141
Change at 0 Hour Day 50n=4 Participants	-0.08	0.171
Change at 0 Hour Day 60n=4 Participants	-0.08	0.275
Change at 0 Hour Day 90n=4 Participants	0.00	0.216
Change at 0 Hour Day 180n=8 Participants	-0.01	0.295
Change at 0 Hour Day 360n=12 Participants	-0.03	0.246
Placebo (Cohort Q)Baselinen=6 Participants	3.40	0.438
Change at 0 Hour Day 40n=2 Participants	0.10	0.283
Change at 0 Hour Day 50n=2 Participants	0.05	0.071
Change at 0 Hour Day 60n=2 Participants	-0.30	0.283
Change at 0 Hour Day 90n=1 Participants	0.00	NA
Change at 0 Hour Day 180n=4 Participants	-0.18	0.411
Change at 0 Hour Day 360n=6 Participants	0.00	0.358
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)Baselinen=12 Participants	3.41	0.188
Change at 0 Hour Day 10n=4 Participants	0.00	0.082
Change at 0 Hour Day 20n=4 Participants	0.03	0.126
Change at 0 Hour Day 30n=4 Participants	-0.03	0.206
Change at 0 Hour Day 180n=12 Participants	-0.01	0.156
Change at 0 Hour Day 360n=12 Participants	0.58	1.012
Placebo (Cohort M)Baselinen=6 Participants	3.35	0.288
Change at 0 Hour Day 10n=2 Participants	-0.20	0.141
Change at 0 Hour Day 20n=1 Participants	-0.10	NA
Change at 0 Hour Day 30n=2 Participants	0.00	0.141
Change at 0 Hour Day 180n=5 Participants	0.00	0.187
Change at 0 Hour Day 360n=5 Participants	0.04	0.182

Safety / tolerability / PK

54 endpoints

Primary/protocol endpoint

Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame:Day 1 up to 6 months after last dose of study medication (up to 18 months)

event count, event

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1

Time frame:0 hour (pre-dose) on Day 1

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1

Time frame:0.25 hours post-infusion start on Day 1

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M

Time frame:0.25 hours post-infusion start on Day 30

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M

Time frame:0 hour (pre-dose) on Day 60

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M

Time frame:0.25 hours post-infusion start on Day 60

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90

Time frame:0.25 hours post-infusion start on Day 90

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M

Time frame:0 hour (pre-dose) on Day 120

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M

Time frame:0.25 hours post-infusion start on Day 120

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M

Time frame:0 hour (pre-dose) on Day 150

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M

Time frame:0.25 hours post-infusion start on Day 150

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180

Time frame:0.25 hours post-infusion start on Day 180

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M

Time frame:0 hour (pre-dose) on Day 210

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M

Time frame:0.25 hours post-infusion start on Day 210

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M

Time frame:0 hour (pre-dose) on Day 240

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M

Time frame:0.25 hours post-infusion start on Day 240

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270

Time frame:0 hour (pre-dose) on Day 270

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270

Time frame:0.25 hours post-infusion start on Day 270

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M

Time frame:0 hour (pre-dose) on Day 300

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M

Time frame:0.25 hours post-infusion start on Day 300

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M

Time frame:0 hour (pre-dose) on Day 330

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M

Time frame:0.25 hours post-infusion start on Day 330

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360

Time frame:0.25 hours post-infusion start on Day 360

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q

Time frame:720 hours post-dose on Day 360 (samples taken on Day 390)

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M

Time frame:0 hour (pre-dose) on Day 390

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q

Time frame:0 hours (pre-dose) on Day 540

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M

Time frame:0 hour (pre-dose) on Day 540

concentration, descriptive

Primary/registry result

Number of Participants With Treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Time frame:Day 1 up to 6 months after last dose of study medication (up to 18 months)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 10 mg/kg (Cohort Q)AEsn=12 Participants	9	-
SAEsn=12 Participants	2	-
Placebo (Cohort Q)AEsn=6 Participants	5	-
SAEsn=6 Participants	1	-
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)AEsn=12 Participants	10	-
SAEsn=12 Participants	1	-
Placebo (Cohort M)AEsn=6 Participants	5	-
SAEsn=6 Participants	0	-

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1

Time frame:0 hour (pre-dose) on Day 1

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=12 Participants	0.00	0.00
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=11 Participants	0.00	0.00

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1

Time frame:0.25 hours post-infusion start on Day 1

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=11 Participants	191080.73	27645.17
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	190826.33	64016.37

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M

Time frame:0.25 hours post-infusion start on Day 30

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=11 Participants	196752.82	25216.35

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M

Time frame:0 hour (pre-dose) on Day 60

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	62261.92	13196.38

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M

Time frame:0.25 hours post-infusion start on Day 60

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=10 Participants	199861.90	33651.83

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90

Time frame:0.25 hours post-infusion start on Day 90

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=11 Participants	218031.73	30864.41
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=10 Participants	212299.30	20405.36

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M

Time frame:0 hour (pre-dose) on Day 120

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	73285.25	20795.73

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M

Time frame:0.25 hours post-infusion start on Day 120

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=10 Participants	227156.80	23587.30

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M

Time frame:0 hour (pre-dose) on Day 150

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	76083.50	19076.47

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M

Time frame:0.25 hours post-infusion start on Day 150

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=11 Participants	222737.91	28714.06

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180

Time frame:0.25 hours post-infusion start on Day 180

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=11 Participants	226842.91	22478.66
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=10 Participants	210905.00	26474.96

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M

Time frame:0 hour (pre-dose) on Day 210

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	77315.33	14237.02

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M

Time frame:0.25 hours post-infusion start on Day 210

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	223667.00	28942.32

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M

Time frame:0 hour (pre-dose) on Day 240

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	82563.83	21690.43

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M

Time frame:0.25 hours post-infusion start on Day 240

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=11 Participants	223715.91	29306.75

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270

Time frame:0 hour (pre-dose) on Day 270

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=11 Participants	22140.00	8996.92
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	69838.25	16735.16

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270

Time frame:0.25 hours post-infusion start on Day 270

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=7 Participants	219643.86	21122.06
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=11 Participants	218116.27	20328.81

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M

Time frame:0 hour (pre-dose) on Day 300

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=11 Participants	71822.18	16913.55

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M

Time frame:0.25 hours post-infusion start on Day 300

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=10 Participants	227333.20	30922.55

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M

Time frame:0 hour (pre-dose) on Day 330

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	71668.67	19448.75

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M

Time frame:0.25 hours post-infusion start on Day 330

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=9 Participants	216841.22	38575.76

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360

Time frame:0.25 hours post-infusion start on Day 360

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=11 Participants	222927.73	29419.72
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=11 Participants	213278.09	31361.98

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q

Time frame:720 hours post-dose on Day 360 (samples taken on Day 390)

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=9 Participants	59095.22	9470.32

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M

Time frame:0 hour (pre-dose) on Day 390

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	74846.08	25913.06

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q

Time frame:0 hours (pre-dose) on Day 540

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg (Cohort Q)n=12 Participants	6245.83	3567.48

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M

Time frame:0 hour (pre-dose) on Day 540

concentration, descriptive

Posted result

Group	Value (mean), ng/mL	Standard deviation
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	5987.08	3571.64

Other (unclassified)

2 endpoints

Other/protocol endpoint/low confidence

Number of Participants With Measurable Serum Anti-Drug Antibody (ADA) Concentration

Time frame:Day 1 up to Month 18

concentration, descriptive

Other_pre_specified/registry result/low confidence

Number of Participants With Measurable Serum Anti-Drug Antibody (ADA) Concentration

Time frame:Day 1 up to Month 18

concentration, descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 10 mg/kg (Cohort Q)n=12 Participants	0	-
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)n=12 Participants	0	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.