← Trials/Trial dossier/NCT00722046

CompletedPhase 2Results posted

Multiple IV Dose Study Of PF-04360365 In Patients With Mild To Moderate Alzheimer's Disease

A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF 04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE.

Lead sponsor

Pfizer

Asset

PF-04360365

Listed sites

Recruiting sites

Enrollment

198

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 number2008-000986-42

Org study IDA9951002

Secondary IDMD IN AD PATIENTAlias Study Number

NCT IDNCT00722046

Timeline

Milestones

Study first posted2008-07-25estimated

Study start2008-12-05actual

Primary completion2011-08-16actual

Study completion2011-08-16actual

Last update posted2022-11-07actual

Results first posted2022-11-07actual

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 criterial 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 (88)

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

Function / daily living

Neuroimaging

Tau biomarkers

Other (unclassified)

Global cognition

4 endpoints

Secondary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline

Time frame:Baseline

ADAS-Cog

descriptive

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19

Time frame:Baseline and Month 19

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline

Time frame:Baseline

ADAS-Cog

descriptive

Posted result

Group	Value (mean), Units on a scale	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	20.0	7.87
PF-04360365 0.5 mg/kg (Part A)n=24 Participants	20.4	8.19
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	20.8	6.08
Placebo (Part A)n=24 Participants	20.0	6.98
PF-04360365 3.0 mg/kg (Part B)n=31 Participants	19.4	6.96
PF-04360365 8.5 mg/kg (Part B)n=31 Participants	24.5	10.15
Placebo (Part B)n=32 Participants	18.4	7.45

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19

Time frame:Baseline and Month 19

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
PF-04360365 0.1 mg/kg (Part A)n=22 Participants	8.36	2.07
PF-04360365 0.5 mg/kg (Part A)n=18 Participants	9.00	2.20
PF-04360365 1.0 mg/kg (Part A)n=16 Participants	9.25	2.20
Placebo (Part A)n=18 Participants	6.98	2.22
PF-04360365 3.0 mg/kg (Part B)n=21 Participants	9.58	1.95
PF-04360365 8.5 mg/kg (Part B)n=21 Participants	8.71	1.99
Placebo (Part B)n=27 Participants	7.85	1.81

Least Squares (LS) Mean Difference1.3890% CI-3.68 - 6.45p0.6504Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference2.0290% CI-3.20 - 7.23p0.5213Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference2.2790% CI-2.94 - 7.48p0.4698Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference1.7390% CI-2.71 - 6.17p0.5183Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference0.8590% CI-3.65 - 5.35p0.7529Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

Function / daily living

4 endpoints

Secondary/protocol endpoint

Disability Assessment for Dementia (DAD) Score at Baseline

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19

Time frame:Baseline and Month 19

change from baseline, improvement

Secondary/registry result

Disability Assessment for Dementia (DAD) Score at Baseline

Time frame:Baseline

descriptive

Posted result

Group	Value (mean), Units on a scale	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	79.6	13.73
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	83.4	12.83
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	78.1	20.55
Placebo (Part A)n=24 Participants	78.0	16.40
PF-04360365 3.0 mg/kg (Part B)n=32 Participants	83.5	13.16
PF-04360365 8.5 mg/kg (Part B)n=31 Participants	77.1	20.16
Placebo (Part B)n=32 Participants	80.7	15.60

Secondary/registry result

Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19

Time frame:Baseline and Month 19

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
PF-04360365 0.1 mg/kg (Part A)n=21 Participants	-20.09	3.80
PF-04360365 0.5 mg/kg (Part A)n=21 Participants	-16.20	3.90
PF-04360365 1.0 mg/kg (Part A)n=18 Participants	-15.18	3.91
Placebo (Part A)n=18 Participants	-16.02	4.07
PF-04360365 3.0 mg/kg (Part B)n=24 Participants	-22.53	4.17
PF-04360365 8.5 mg/kg (Part B)n=22 Participants	-18.12	4.30
Placebo (Part B)n=27 Participants	-18.44	4.00

LS Mean Difference-4.0790% CI-13.38 - 5.24p0.4688Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference-0.1890% CI-9.59 - 9.22p0.9743Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference0.8490% CI-8.57 - 10.25p0.8824Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference-4.0990% CI-13.77 - 5.58p0.4831Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

LS Mean Difference0.3290% CI-9.48 - 10.13p0.9562Mixed Models Analysis

Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.

Amyloid biomarkers

12 endpoints

Secondary/protocol endpoint

Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)

Time frame:0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720

concentration, descriptive

Secondary/protocol endpoint

Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)

Time frame:0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720

concentration, descriptive

Secondary/protocol endpoint

Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)

Time frame:0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720

concentration, descriptive

Secondary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Secondary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Secondary/protocol endpoint

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Secondary/registry result

Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)

Time frame:0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)0 Hour Day 1n=25 Participants	294.12	95.78
2 Hours Day 1n=22 Participants	2128.73	537.63
0 Hour Day 60n=24 Participants	1828.13	976.47
2 Hours Day 60n=23 Participants	3892.17	1013.64
Day 90n=25 Participants	3997.20	1322.48
0 Hour Day 120n=25 Participants	2440.00	1054.77
2 Hours Day 120n=22 Participants	4425.05	1427.10
Day 150n=24 Participants	4531.25	1597.31
0 Hour Day 180n=24 Participants	3017.50	1296.78
2 Hours Day 180n=21 Participants	5544.76	2044.34
Day 210n=24 Participants	4673.33	1524.00
0 Hour Day 240n=25 Participants	3085.20	1190.23
2 Hours Day 240n=21 Participants	5269.05	1614.58
0 Hour Day 300n=25 Participants	2963.6	1047.13
2 Hours Day 300n=24 Participants	4984.58	1496.74
0 Hour Day 360n=23 Participants	3053.04	972.76
2 Hours Day 360n=22 Participants	5253.18	1802.73
Day 390n=22 Participants	4300.82	1647.44
0 Hour Day 420n=21 Participants	3123.19	1245.10
2 Hours Day 420n=18 Participants	5090.56	1713.37
0 Hour Day 480n=23 Participants	2899.17	1058.84
2 Hours Day 480n=21 Participants	5196.19	1676.54
0 Hour Day 540n=23 Participants	3163.48	1389.06
2 Hours Day 540n=20 Participants	5755.50	3402.11
Day 570n=22 Participants	4568.64	2097.91
Day 660n=21 Participants	2422.29	1956.43
Day 720n=21 Participants	1383.76	449.57
PF-04360365 0.5 mg/kg (Part A)0 Hour Day 1n=25 Participants	229.68	112.23
2 Hours Day 1n=20 Participants	2106.50	480.76
0 Hour Day 60n=25 Participants	8122.40	2209.66
2 Hours Day 60n=23 Participants	9645.22	1953.32
Day 90n=25 Participants	20476.00	5034.49
0 Hour Day 120n=24 Participants	11435.00	3379.92
2 Hours Day 120n=25 Participants	12988.80	4021.06
Day 150n=25 Participants	23600.00	6871.74
0 Hour Day 180n=25 Participants	14386.00	5203.12
2 Hours Day 180n=23 Participants	16894.78	5283.81
Day 210n=24 Participants	25108.33	8120.77
0 Hour Day 240n=24 Participants	15445.83	5718.03
2 Hours Day 240n=22 Participants	15930.91	6681.72
0 Hour Day 300n=22 Participants	14710.45	6472.62
2 Hours Day 300n=20 Participants	15878.00	7211.88
0 Hour Day 360n=21 Participants	14313.81	6254.35
2 Hours Day 360n=19 Participants	14153.16	6473.23
Day 390n=21 Participants	19984.76	7108.94
0 Hour Day 420n=21 Participants	14675.24	6367.51
2 Hours Day 420n=19 Participants	14711.58	5023.57
0 Hour Day 480n=21 Participants	13864.29	6772.94
2 Hours Day 480n=19 Participants	16105.79	7332.47
0 Hour Day 540n=19 Participants	14449.47	6474.26
2 Hours Day 540n=15 Participants	15516.00	6002.06
Day 570n=21 Participants	22257.14	10734.97
Day 660n=18 Participants	8181.11	7497.62
Day 720n=20 Participants	3773.5	2447.14
PF-04360365 1.0 mg/kg (Part A)0 Hour Day 1n=25 Participants	355.80	514.90
2 Hours Day 1n=23 Participants	2199.87	621.29
0 Hour Day 60n=25 Participants	15558.40	4994.54
2 Hours Day 60n=24 Participants	16952.50	4358.13
Day 90n=25 Participants	36904.00	12258.21
0 Hour Day 120n=25 Participants	22416.00	6636.56
2 Hours Day 120n=23 Participants	22260.87	6276.85
Day 150n=25 Participants	43872.00	10714.22
0 Hour Day 180n=25 Participants	26036.00	7745.58
2 Hours Day 180n=22 Participants	27118.18	7787.09
Day 210n=25 Participants	49676.00	12637.16
0 Hour Day 240n=24 Participants	28520.83	8766.83
2 Hours Day 240n=24 Participants	25532.50	7102.35
0 Hour Day 300n=24 Participants	28366.67	14592.96
2 Hours Day 300n=23 Participants	28647.83	14306.10
0 Hour Day 360n=23 Participants	27999.13	13280.23
2 Hours Day 360n=21 Participants	23664.29	11040.37
Day 390n=22 Participants	40330.45	13327.52
0 Hour Day 420n=21 Participants	26109.52	13214.13
2 Hours Day 420n=18 Participants	23987.78	9082.14
0 Hour Day 480n=20 Participants	29448.00	11647.42
2 Hours Day 480n=19 Participants	28064.21	11182.90
0 Hour Day 540n=16 Participants	32468.13	14928.53
2 Hours Day 540n=15 Participants	30778.67	16628.98
Day 570n=17 Participants	49461.76	22369.81
Day 660n=18 Participants	20496.11	20540.31
Day 720n=18 Participants	7876.67	5846.23
Placebo (Part A)0 Hour Day 1n=24 Participants	273.21	96.00
2 Hours Day 1n=22 Participants	282.86	75.09
0 Hour Day 60n=24 Participants	332.46	94.47
2 Hours Day 60n=21 Participants	291.62	108.42
Day 90n=24 Participants	341.33	80.25
0 Hour Day 120n=23 Participants	340.87	96.43
2 Hours Day 120n=20 Participants	361.80	53.92
Day 150n=23 Participants	360.30	74.99
0 Hour Day 180n=22 Participants	367.55	63.64
2 Hours Day 180n=18 Participants	363.61	72.24
Day 210n=22 Participants	385.27	71.98
0 Hour Day 240n=21 Participants	327.29	67.08
2 Hours Day 240n=21 Participants	336.24	47.77
0 Hour Day 300n=21 Participants	311.43	63.44
2 Hours Day 300n=20 Participants	297.20	97.78
0 Hour Day 360n=21 Participants	287.90	103.73
2 Hours Day 360n=18 Participants	277.72	94.14
Day 390n=21 Participants	303.76	125.67
0 Hour Day 420n=20 Participants	318.45	76.39
2 Hours Day 420n=16 Participants	318.88	61.86
0 Hour Day 480n=19 Participants	339.16	86.94
2 Hours Day 480n=16 Participants	396.44	98.10
0 Hour Day 540n=18 Participants	359.06	91.66
2 Hours Day 540n=17 Participants	387.65	119.66
Day 570n=17 Participants	356.71	151.05
Day 660n=17 Participants	421.71	140.09
Day 720n=18 Participants	419.11	143.12
PF-04360365 3.0 mg/kg (Part B)0 Hour Day 1n=32 Participants	607.50	765.24
2 Hours Day 1n=28 Participants	2446.64	1055.11
0 Hour Day 60n=29 Participants	48603.45	20147.32
2 Hours Day 60n=29 Participants	41772.41	11979.65
Day 90n=30 Participants	89856.67	20377.45
0 Hour Day 120n=30 Participants	61270.00	22462.23
2 Hours Day 120n=27 Participants	49233.33	18308.66
Day 150n=30 Participants	85203.33	21436.55
0 Hour Day 180n=28 Participants	55125.00	15273.79
2 Hours Day 180n=25 Participants	47316.00	15189.79
Day 210n=28 Participants	84810.71	20382.91
0 Hour Day 240n=27 Participants	48344.44	14065.65
2 Hours Day 240n=25 Participants	47100.00	15547.48
0 Hour Day 300n=26 Participants	62607.69	21254.16
2 Hours Day 300n=24 Participants	53808.33	18101.79
0 Hour Day 360n=26 Participants	58157.69	15871.24
2 Hours Day 360n=24 Participants	50820.83	16118.20
Day 390n=26 Participants	75133.85	23426.25
0 Hour Day 420n=23 Participants	55273.91	22852.20
2 Hours Day 420n=21 Participants	54461.90	22287.94
0 Hour Day 480n=24 Participants	75033.33	29410.21
2 Hours Day 480n=21 Participants	77633.33	35071.25
0 Hour Day 540n=22 Participants	53154.55	18919.37
2 Hours Day 540n=20 Participants	54190.00	20426.89
Day 570n=21 Participants	69914.29	19836.82
Day 660n=22 Participants	28198.18	10933.08
Day 720n=23 Participants	14912.65	8037.28
PF-04360365 8.5 mg/kg (Part B)0 Hour Day 1n=31 Participants	337.87	112.84
2 Hours Day 1n=28 Participants	2648.93	695.78
0 Hour Day 60n=29 Participants	91475.86	22246.33
2 Hours Day 60n=22 Participants	83050.00	28159.10
Day 90n=28 Participants	127132.14	25567.72
0 Hour Day 120n=27 Participants	110074.07	23932.00
2 Hours Day 120n=23 Participants	91508.70	20558.34
Day 150n=27 Participants	135288.89	29714.08
0 Hour Day 180n=25 Participants	93180.00	28531.81
2 Hours Day 180n=23 Participants	81960.87	26561.69
Day 210n=26 Participants	116703.85	37969.45
0 Hour Day 240n=26 Participants	83653.85	28195.07
2 Hours Day 240n=24 Participants	78354.17	28042.48
0 Hour Day 300n=27 Participants	96537.04	44313.44
2 Hours Day 300n=21 Participants	79900.00	26477.07
0 Hour Day 360n=23 Participants	100691.30	37696.25
2 Hours Day 360n=19 Participants	84168.42	34779.51
Day 390n=23 Participants	114104.35	31087.60
0 Hour Day 420n=21 Participants	89038.10	31754.61
2 Hours Day 420n=15 Participants	89080.00	25517.79
0 Hour Day 480n=23 Participants	97239.57	40197.50
2 Hours Day 480n=17 Participants	100941.18	36351.53
0 Hour Day 540n=20 Participants	77400.00	37951.50
2 Hours Day 540n=14 Participants	94271.43	36384.07
Day 570n=21 Participants	90576.19	60817.37
Day 660n=21 Participants	49011.19	35384.55
Day 720n=20 Participants	22663.00	14507.34
Placebo (Part B)0 Hour Day 1n=31 Participants	382.10	158.90
2 Hours Day 1n=27 Participants	380.07	101.11
0 Hour Day 60n=32 Participants	405.44	245.46
2 Hours Day 60n=29 Participants	380.90	119.24
Day 90n=32 Participants	386.50	167.65
0 Hour Day 120n=32 Participants	375.22	118.27
2 Hours Day 120n=29 Participants	396.10	117.46
Day 150n=32 Participants	363.38	126.56
0 Hour Day 180n=31 Participants	297.87	122.91
2 Hours Day 180n=29 Participants	289.24	139.31
Day 210n=31 Participants	301.84	110.90
0 Hour Day 240n=30 Participants	318.37	116.19
2 Hours Day 240n=29 Participants	350.28	130.39
0 Hour Day 300n=30 Participants	327.83	112.77
2 Hours Day 300n=29 Participants	353.24	129.21
0 Hour Day 360n=28 Participants	353.86	108.68
2 Hours Day 360n=26 Participants	351.31	105.35
Day 390n=28 Participants	338.79	92.17
0 Hour Day 420n=26 Participants	376.08	172.83
2 Hours Day 420n=25 Participants	394.04	229.59
0 Hour Day 480n=27 Participants	356.11	197.30
2 Hours Day 480n=25 Participants	402.72	195.38
0 Hour Day 540n=24 Participants	493.71	251.99
2 Hours Day 540n=24 Participants	455.04	201.94
Day 570n=24 Participants	400.58	175.08
Day 660n=26 Participants	475.46	386.01
Day 720n=25 Participants	421.44	170.96

Secondary/registry result

Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)

Time frame:0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)0 Hour Day 1n=25 Participants	185.52	109.70
2 Hours Day 1n=22 Participants	1239.41	388.07
0 Hour Day 60n=24 Participants	1073.50	409.71
2 Hours Day 60n=23 Participants	2502.39	920.12
Day 90n=25 Participants	2096.40	896.20
0 Hour Day 120n=25 Participants	1345.72	525.64
2 Hours Day 120n=22 Participants	3000.00	1145.59
Day 150n=24 Participants	2564.21	1566.85
0 Hour Day 180n=24 Participants	1632.54	931.22
2 Hours Day 180n=21 Participants	2973.05	1614.36
Day 210n=24 Participants	2274.58	878.71
0 Hour Day 240n=25 Participants	1471.84	549.70
2 Hours Day 240n=21 Participants	2868.10	778.74
0 Hour Day 300n=25 Participants	1630.16	662.16
2 Hours Day 300n=24 Participants	2756.25	1012.41
0 Hour Day 360n=23 Participants	1694.26	566.45
2 Hours Day 360n=22 Participants	3277.27	983.77
Day 390n=22 Participants	2543.50	1446.05
0 Hour Day 420n=21 Participants	1451.33	602.01
2 Hours Day 420n=18 Participants	2647.78	826.97
0 Hour Day 480n=23 Participants	1931.78	1339.28
2 Hours Day 480n=21 Participants	3336.29	1529.23
0 Hour Day 540n=23 Participants	2437.70	1483.48
2 Hours Day 540n=20 Participants	4149.30	1711.36
Day 570n=22 Participants	3147.27	1910.78
Day 660n=21 Participants	1318.67	927.31
Day 720n=21 Participants	913.57	273.04
PF-04360365 0.5 mg/kg (Part A)0 Hour Day 1n=25 Participants	145.92	104.50
2 Hours Day 1n=20 Participants	1580.70	500.06
0 Hour Day 60n=25 Participants	5860.00	1923.23
2 Hours Day 60n=23 Participants	8676.09	2600.95
Day 90n=25 Participants	13888.80	5357.63
0 Hour Day 120n=24 Participants	7823.75	3119.88
2 Hours Day 120n=25 Participants	11108.00	3594.09
Day 150n=25 Participants	16254.80	5774.43
0 Hour Day 180n=25 Participants	8604.40	3269.47
2 Hours Day 180n=23 Participants	11533.48	3718.57
Day 210n=24 Participants	14409.58	5966.02
0 Hour Day 240n=24 Participants	8583.75	4003.84
2 Hours Day 240n=22 Participants	11830.45	5542.51
0 Hour Day 300n=22 Participants	8989.55	4776.13
2 Hours Day 300n=20 Participants	10428.50	2989.20
0 Hour Day 360n=21 Participants	8194.76	3665.29
2 Hours Day 360n=19 Participants	11555.79	3710.85
Day 390n=21 Participants	10594.76	3948.17
0 Hour Day 420n=21 Participants	7863.81	3449.31
2 Hours Day 420n=19 Participants	10538.42	4177.09
0 Hour Day 480n=21 Participants	10108.10	5878.70
2 Hours Day 480n=19 Participants	12793.68	5639.73
0 Hour Day 540n=19 Participants	10103.16	6545.00
2 Hours Day 540n=15 Participants	12428.67	6799.53
Day 570n=21 Participants	16370.00	10166.72
Day 660n=17 Participants	4411.24	3426.58
Day 720n=20 Participants	3631.50	2062.26
PF-04360365 1.0 mg/kg (Part A)0 Hour Day 1n=25 Participants	162.04	125.00
2 Hours Day 1n=23 Participants	1665.57	953.50
0 Hour Day 60n=25 Participants	11643.20	4588.36
2 Hours Day 60n=24 Participants	14517.08	6129.96
Day 90n=25 Participants	25008.00	8167.92
0 Hour Day 120n=25 Participants	16724.00	7330.78
2 Hours Day 120n=23 Participants	20834.78	8115.40
Day 150n=25 Participants	27640.00	11619.21
0 Hour Day 180n=25 Participants	17727.60	7878.69
2 Hours Day 180n=22 Participants	23146.36	9074.15
Day 210n=25 Participants	28548.00	11006.03
0 Hour Day 240n=24 Participants	16937.08	7343.63
2 Hours Day 240n=24 Participants	20021.25	7600.16
0 Hour Day 300n=24 Participants	17817.08	13181.85
2 Hours Day 300n=23 Participants	17809.57	6105.73
0 Hour Day 360n=23 Participants	15651.74	5075.04
2 Hours Day 360n=21 Participants	16970.95	6137.24
Day 390n=22 Participants	21660.45	7216.95
0 Hour Day 420n=21 Participants	14975.24	7980.85
2 Hours Day 420n=18 Participants	16612.22	5658.05
0 Hour Day 480n=20 Participants	16535.00	9242.28
2 Hours Day 480n=19 Participants	16610.00	6540.14
0 Hour Day 540n=16 Participants	27048.75	23150.54
2 Hours Day 540n=15 Participants	31972.67	24882.62
Day 570n=17 Participants	32728.24	20157.92
Day 660n=18 Participants	8720.00	4958.03
Day 720n=17 Participants	6642.94	5669.98
Placebo (Part A)0 Hour Day 1n=24 Participants	180.54	108.32
2 Hours Day 1n=22 Participants	187.95	55.99
0 Hour Day 60n=24 Participants	209.46	71.27
2 Hours Day 60n=21 Participants	227.57	60.84
Day 90n=24 Participants	204.25	71.71
0 Hour Day 120n=23 Participants	192.91	110.77
2 Hours Day 120n=20 Participants	191.95	76.36
Day 150n=23 Participants	195.96	78.74
0 Hour Day 180n=22 Participants	182.41	86.46
2 Hours Day 180n=18 Participants	225.17	94.23
Day 210n=22 Participants	191.82	92.92
0 Hour Day 240n=21 Participants	164.29	46.78
2 Hours Day 240n=21 Participants	182.71	60.37
0 Hour Day 300n=21 Participants	190.38	80.76
2 Hours Day 300n=20 Participants	208.85	108.79
0 Hour Day 360n=21 Participants	236.71	190.38
2 Hours Day 360n=18 Participants	211.33	101.44
Day 390n=21 Participants	150.81	85.06
0 Hour Day 420n=20 Participants	157.80	91.81
2 Hours Day 420n=16 Participants	151.13	86.07
0 Hour Day 480n=18 Participants	139.61	106.88
2 Hours Day 480n=15 Participants	133.53	91.30
0 Hour Day 540n=18 Participants	190.94	127.00
2 Hours Day 540n=16 Participants	186.69	95.55
Day 570n=17 Participants	237.12	176.71
Day 660n=16 Participants	290.63	244.94
Day 720n=18 Participants	330.11	112.78
PF-04360365 3.0 mg/kg (Part B)0 Hour Day 1n=32 Participants	318.09	495.37
2 Hours Day 1n=28 Participants	1924.50	773.00
0 Hour Day 60n=29 Participants	33203.45	13116.74
2 Hours Day 60n=29 Participants	32306.90	11373.09
Day 90n=30 Participants	57333.33	15829.03
0 Hour Day 120n=30 Participants	36926.67	15677.13
2 Hours Day 120n=27 Participants	38466.67	12659.44
Day 150n=30 Participants	52753.33	19076.48
0 Hour Day 180n=28 Participants	35539.29	12873.73
2 Hours Day 180n=25 Participants	38644.00	13630.61
Day 210n=28 Participants	51135.71	14603.53
0 Hour Day 240n=27 Participants	36451.85	10133.13
2 Hours Day 240n=25 Participants	35996.00	9149.79
0 Hour Day 300n=26 Participants	37692.31	15132.16
2 Hours Day 300n=24 Participants	42245.83	12637.11
0 Hour Day 360n=26 Participants	30459.62	13619.52
2 Hours Day 360n=24 Participants	31191.67	10742.40
Day 390n=25 Participants	54165.20	20804.90
0 Hour Day 420n=24 Participants	47820.83	23683.71
2 Hours Day 420n=21 Participants	44047.62	21069.28
0 Hour Day 480n=23 Participants	74334.78	21163.94
2 Hours Day 480n=21 Participants	66049.05	37625.89
0 Hour Day 540n=22 Participants	52720.91	26005.06
2 Hours Day 540n=20 Participants	52960.00	25018.95
Day 570n=21 Participants	58548.10	25034.67
Day 660n=22 Participants	27949.09	14956.33
Day 720n=23 Participants	13954.48	9828.94
PF-04360365 8.5 mg/kg (Part B)0 Hour Day 1n=31 Participants	192.03	199.53
2 Hours Day 1n=28 Participants	1764.64	546.77
0 Hour Day 60n=29 Participants	66972.41	19944.83
2 Hours Day 60n=22 Participants	69627.27	21824.67
Day 90n=28 Participants	95967.86	27202.68
0 Hour Day 120n=27 Participants	75514.81	22013.70
2 Hours Day 120n=23 Participants	76860.87	22351.34
Day 150n=27 Participants	75033.33	19112.32
0 Hour Day 180n=26 Participants	67450.00	21320.30
2 Hours Day 180n=23 Participants	61634.78	21758.96
Day 210n=27 Participants	71200.00	17902.92
0 Hour Day 240n=26 Participants	58873.08	21088.17
2 Hours Day 240n=24 Participants	58225.00	20401.28
0 Hour Day 300n=27 Participants	55488.89	17874.01
2 Hours Day 300n=21 Participants	54838.10	14484.59
0 Hour Day 360n=23 Participants	48904.35	18386.82
2 Hours Day 360n=19 Participants	64868.42	30014.29
Day 390n=23 Participants	77274.78	33435.47
0 Hour Day 420n=21 Participants	65819.05	42467.11
2 Hours Day 420n=15 Participants	70846.67	41555.50
0 Hour Day 480n=22 Participants	77302.27	44463.25
2 Hours Day 480n=18 Participants	102094.44	43738.40
0 Hour Day 540n=21 Participants	77010.48	50743.64
2 Hours Day 540n=16 Participants	84750.00	42228.62
Day 570n=21 Participants	77292.38	46608.10
Day 660n=21 Participants	42087.62	26245.07
Day 720n=20 Participants	22094.00	13058.87
Placebo (Part B)0 Hour Day 1n=31 Participants	184.19	124.59
2 Hours Day 1n=27 Participants	180.22	117.09
0 Hour Day 60n=32 Participants	158.16	121.12
2 Hours Day 60n=29 Participants	195.83	110.94
Day 90n=32 Participants	157.31	107.72
0 Hour Day 120n=32 Participants	168.41	81.95
2 Hours Day 120n=29 Participants	177.55	94.50
Day 150n=32 Participants	148.47	106.04
0 Hour Day 180n=31 Participants	161.48	166.60
2 Hours Day 180n=29 Participants	150.79	99.12
Day 210n=31 Participants	189.13	78.73
0 Hour Day 240n=30 Participants	141.40	106.52
2 Hours Day 240n=29 Participants	171.66	98.41
0 Hour Day 300n=30 Participants	149.20	122.88
2 Hours Day 300n=29 Participants	245.31	239.90
0 Hour Day 360n=28 Participants	87.18	96.11
2 Hours Day 360n=25 Participants	156.68	148.86
Day 390n=28 Participants	131.07	102.02
0 Hour Day 420n=26 Participants	201.31	165.16
2 Hours Day 420n=24 Participants	181.83	123.40
0 Hour Day 480n=25 Participants	252.00	135.67
2 Hours Day 480n=23 Participants	310.39	302.75
0 Hour Day 540n=23 Participants	198.00	114.84
2 Hours Day 540n=23 Participants	230.30	71.67
Day 570n=24 Participants	192.13	104.14
Day 660n=16 Participants	321.46	140.99
Day 720n=25 Participants	358.04	148.65

Secondary/registry result

Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)

Time frame:0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)0 Hour Day 1n=25 Participants	NA	NA
2 Hours Day 1n=25 Participants	NA	NA
0 Hour Day 60n=25 Participants	NA	NA
2 Hours Day 60n=25 Participants	NA	NA
Day 90n=25 Participants	NA	NA
0 Hour Day 120n=25 Participants	NA	NA
2 Hours Day 120n=25 Participants	NA	NA
Day 150n=25 Participants	NA	NA
0 Hour Day 180n=25 Participants	NA	NA
2 Hours Day 180n=25 Participants	NA	NA
Day 210n=25 Participants	NA	NA
0 Hour Day 240n=25 Participants	NA	NA
2 Hours Day 240n=25 Participants	NA	NA
0 Hour Day 300n=25 Participants	NA	NA
2 Hours Day 300n=25 Participants	NA	NA
0 Hour Day 360n=25 Participants	NA	NA
2 Hours Day 360n=25 Participants	NA	NA
Day 390n=25 Participants	NA	NA
0 Hour Day 420n=25 Participants	NA	NA
2 Hours Day 420n=25 Participants	NA	NA
0 Hour Day 480n=25 Participants	NA	NA
2 Hours Day 480n=25 Participants	NA	NA
0 Hour Day 540n=25 Participants	NA	NA
2 Hours Day 540n=25 Participants	NA	NA
Day 570n=25 Participants	NA	NA
Day 660n=25 Participants	NA	NA
Day 720n=25 Participants	NA	NA
PF-04360365 0.5 mg/kg (Part A)0 Hour Day 1n=25 Participants	NA	NA
2 Hours Day 1n=25 Participants	NA	NA
0 Hour Day 60n=25 Participants	NA	NA
2 Hours Day 60n=25 Participants	NA	NA
Day 90n=25 Participants	NA	NA
0 Hour Day 120n=25 Participants	NA	NA
2 Hours Day 120n=25 Participants	NA	NA
Day 150n=25 Participants	NA	NA
0 Hour Day 180n=25 Participants	NA	NA
2 Hours Day 180n=25 Participants	NA	NA
Day 210n=25 Participants	NA	NA
0 Hour Day 240n=25 Participants	NA	NA
2 Hours Day 240n=25 Participants	NA	NA
0 Hour Day 300n=25 Participants	NA	NA
2 Hours Day 300n=25 Participants	NA	NA
0 Hour Day 360n=25 Participants	NA	NA
2 Hours Day 360n=25 Participants	NA	NA
Day 390n=25 Participants	NA	NA
0 Hour Day 420n=25 Participants	NA	NA
2 Hours Day 420n=25 Participants	NA	NA
0 Hour Day 480n=25 Participants	NA	NA
2 Hours Day 480n=25 Participants	NA	NA
0 Hour Day 540n=25 Participants	NA	NA
2 Hours Day 540n=25 Participants	NA	NA
Day 570n=25 Participants	NA	NA
Day 660n=25 Participants	NA	NA
Day 720n=25 Participants	NA	NA
PF-04360365 1.0 mg/kg (Part A)0 Hour Day 1n=25 Participants	NA	NA
2 Hours Day 1n=25 Participants	NA	NA
0 Hour Day 60n=25 Participants	NA	NA
2 Hours Day 60n=25 Participants	NA	NA
Day 90n=25 Participants	NA	NA
0 Hour Day 120n=25 Participants	NA	NA
2 Hours Day 120n=25 Participants	NA	NA
Day 150n=25 Participants	NA	NA
0 Hour Day 180n=25 Participants	NA	NA
2 Hours Day 180n=25 Participants	NA	NA
Day 210n=25 Participants	NA	NA
0 Hour Day 240n=25 Participants	NA	NA
2 Hours Day 240n=25 Participants	NA	NA
0 Hour Day 300n=25 Participants	NA	NA
2 Hours Day 300n=25 Participants	NA	NA
0 Hour Day 360n=25 Participants	NA	NA
2 Hours Day 360n=25 Participants	NA	NA
Day 390n=25 Participants	NA	NA
0 Hour Day 420n=25 Participants	NA	NA
2 Hours Day 420n=25 Participants	NA	NA
0 Hour Day 480n=25 Participants	NA	NA
2 Hours Day 480n=25 Participants	NA	NA
0 Hour Day 540n=25 Participants	NA	NA
2 Hours Day 540n=25 Participants	NA	NA
Day 570n=25 Participants	NA	NA
Day 660n=25 Participants	NA	NA
Day 720n=25 Participants	NA	NA
Placebo (Part A)0 Hour Day 1n=24 Participants	NA	NA
2 Hours Day 1n=24 Participants	NA	NA
0 Hour Day 60n=24 Participants	NA	NA
2 Hours Day 60n=24 Participants	NA	NA
Day 90n=24 Participants	NA	NA
0 Hour Day 120n=24 Participants	NA	NA
2 Hours Day 120n=24 Participants	NA	NA
Day 150n=24 Participants	NA	NA
0 Hour Day 180n=24 Participants	NA	NA
2 Hours Day 180n=24 Participants	NA	NA
Day 210n=24 Participants	NA	NA
0 Hour Day 240n=24 Participants	NA	NA
2 Hours Day 240n=24 Participants	NA	NA
0 Hour Day 300n=24 Participants	NA	NA
2 Hours Day 300n=24 Participants	NA	NA
0 Hour Day 360n=24 Participants	NA	NA
2 Hours Day 360n=24 Participants	NA	NA
Day 390n=24 Participants	NA	NA
0 Hour Day 420n=24 Participants	NA	NA
2 Hours Day 420n=24 Participants	NA	NA
0 Hour Day 480n=24 Participants	NA	NA
2 Hours Day 480n=24 Participants	NA	NA
0 Hour Day 540n=24 Participants	NA	NA
2 Hours Day 540n=24 Participants	NA	NA
Day 570n=24 Participants	NA	NA
Day 660n=24 Participants	NA	NA
Day 720n=24 Participants	NA	NA
PF-04360365 3.0 mg/kg (Part B)0 Hour Day 1n=30 Participants	13.43	25.72
2 Hours Day 1n=25 Participants	11.13	24.15
0 Hour Day 60n=28 Participants	24.82	50.09
2 Hours Day 60n=29 Participants	15.27	38.72
Day 90n=27 Participants	15.34	37.22
0 Hour Day 120n=30 Participants	13.62	31.54
2 Hours Day 120n=27 Participants	11.35	27.02
Day 150n=30 Participants	12.01	32.98
0 Hour Day 180n=27 Participants	13.11	30.57
2 Hours Day 180n=25 Participants	12.66	27.27
Day 210n=27 Participants	10.08	32.66
0 Hour Day 240n=27 Participants	13.19	26.27
2 Hours Day 240n=25 Participants	8.83	20.44
0 Hour Day 300n=26 Participants	12.68	25.00
2 Hours Day 300n=24 Participants	12.21	22.64
0 Hour Day 360n=26 Participants	12.08	30.02
2 Hours Day 360n=24 Participants	11.93	22.97
Day 390n=26 Participants	12.57	30.68
0 Hour Day 420n=24 Participants	9.89	28.01
2 Hours Day 420n=21 Participants	6.09	22.85
0 Hour Day 480n=24 Participants	6.94	16.00
2 Hours Day 480n=21 Participants	7.50	14.00
0 Hour Day 540n=22 Participants	5.05	14.19
2 Hours Day 540n=20 Participants	4.36	11.09
Day 570n=21 Participants	4.53	15.68
Day 660n=22 Participants	7.09	33.26
Day 720n=22 Participants	7.70	29.70
PF-04360365 8.5 mg/kg (Part B)0 Hour Day 1n=31 Participants	19.14	46.75
2 Hours Day 1n=28 Participants	22.23	56.62
0 Hour Day 60n=29 Participants	33.21	51.41
2 Hours Day 60n=22 Participants	60.77	210.62
Day 90n=28 Participants	41.53	89.72
0 Hour Day 120n=27 Participants	32.26	56.72
2 Hours Day 120n=23 Participants	14.86	37.79
Day 150n=27 Participants	43.57	125.33
0 Hour Day 180n=26 Participants	41.39	77.77
2 Hours Day 180n=23 Participants	21.64	43.59
Day 210n=27 Participants	24.06	57.43
0 Hour Day 240n=26 Participants	35.47	83.01
2 Hours Day 240n=24 Participants	28.11	66.93
0 Hour Day 300n=27 Participants	55.96	142.05
2 Hours Day 300n=21 Participants	57.44	156.63
0 Hour Day 360n=23 Participants	66.16	194.92
2 Hours Day 360n=19 Participants	62.57	164.16
Day 390n=23 Participants	72.92	220.09
0 Hour Day 420n=21 Participants	54.91	131.76
2 Hours Day 420n=15 Participants	64.51	162.91
0 Hour Day 480n=23 Participants	30.32	91.79
2 Hours Day 480n=18 Participants	37.13	98.93
0 Hour Day 540n=21 Participants	36.62	87.98
2 Hours Day 540n=16 Participants	26.73	70.63
Day 570n=21 Participants	43.1	114.46
Day 660n=21 Participants	26.21	106.89
Day 720n=19 Participants	33.11	144.30
Placebo (Part B)0 Hour Day 1n=32 Participants	NA	NA
2 Hours Day 1n=32 Participants	NA	NA
0 Hour Day 60n=32 Participants	NA	NA
2 Hours Day 60n=32 Participants	NA	NA
Day 90n=32 Participants	NA	NA
0 Hour Day 120n=32 Participants	NA	NA
2 Hours Day 120n=32 Participants	NA	NA
Day 150n=32 Participants	NA	NA
0 Hour Day 180n=32 Participants	NA	NA
2 Hours Day 180n=32 Participants	NA	NA
Day 210n=32 Participants	NA	NA
0 Hour Day 240n=32 Participants	NA	NA
2 Hours Day 240n=32 Participants	NA	NA
0 Hour Day 300n=32 Participants	NA	NA
2 Hours Day 300n=32 Participants	NA	NA
0 Hour Day 360n=32 Participants	NA	NA
2 Hours Day 360n=32 Participants	NA	NA
Day 390n=32 Participants	NA	NA
0 Hour Day 420n=32 Participants	NA	NA
2 Hours Day 420n=32 Participants	NA	NA
0 Hour Day 480n=32 Participants	NA	NA
2 Hours Day 480n=32 Participants	NA	NA
0 Hour Day 540n=32 Participants	NA	NA
2 Hours Day 540n=32 Participants	NA	NA
Day 570n=32 Participants	NA	NA
Day 660n=32 Participants	NA	NA
Day 720n=32 Participants	NA	NA

Secondary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)Day 0n=3 Participants	27400.00	8361.22
Day 90n=3 Participants	31766.67	6906.04
Day 570n=1 Participants	12200.00	NA
PF-04360365 0.5 mg/kg (Part A)Day 0n=8 Participants	30187.50	10584.28
Day 90n=6 Participants	31050.00	9056.88
Day 570n=3 Participants	32466.67	7305.02
PF-04360365 1.0 mg/kg (Part A)Day 0n=4 Participants	32150.00	10033.44
Day 90n=4 Participants	22775.00	3856.06
Day 570n=2 Participants	15250.00	7424.62
Placebo (Part A)Day 0n=4 Participants	18425.00	5034.13
Day 90n=4 Participants	16025.00	3279.61
Day 570n=2 Participants	11650.00	1626.35
PF-04360365 3.0 mg/kg (Part B)Day 0n=13 Participants	31553.85	10242.12
Day 90n=11 Participants	27850.00	11601.40
Day 570n=8 Participants	13378.75	3643.53
PF-04360365 8.5 mg/kg (Part B)Day 0n=11 Participants	25536.36	9602.63
Day 90n=10 Participants	31580.00	16461.79
Day 570n=7 Participants	10688.57	2937.67
Placebo (Part B)Day 0n=17 Participants	25923.53	8724.93
Day 90n=14 Participants	22888.57	9294.70
Day 570n=8 Participants	10467.50	2876.30

Secondary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)Day 0n=3 Participants	18100.00	4513.31
Day 90n=3 Participants	16833.33	4244.21
Day 570n=1 Participants	4930.00	NA
PF-04360365 0.5 mg/kg (Part A)Day 0n=8 Participants	11907.50	3569.78
Day 90n=6 Participants	14733.33	4341.27
Day 570n=4 Participants	10775.00	5811.55
PF-04360365 1.0 mg/kg (Part A)Day 0n=4 Participants	11700.00	1525.34
Day 90n=4 Participants	12350.00	2537.06
Day 570n=2 Participants	8445.00	2128.39
Placebo (Part A)Day 0n=4 Participants	7947.50	2501.00
Day 90n=4 Participants	7977.50	1542.95
Day 570n=2 Participants	5235.00	572.76
PF-04360365 3.0 mg/kg (Part B)Day 0n=13 Participants	14672.31	6776.14
Day 90n=11 Participants	14106.36	5225.42
Day 570n=9 Participants	7108.89	1712.55
PF-04360365 8.5 mg/kg (Part B)Day 0n=11 Participants	12301.82	4272.94
Day 90n=10 Participants	13733.00	4712.08
Day 570n=6 Participants	9315.00	3779.86
Placebo (Part B)Day 0n=17 Participants	12713.53	5960.78
Day 90n=14 Participants	11745.71	3627.05
Day 570n=8 Participants	4730.00	1235.86

Secondary/registry result

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)Day 0n=3 Participants	983.00	370.31
Day 90n=3 Participants	1009.00	298.29
Day 570n=1 Participants	802.00	NA
PF-04360365 0.5 mg/kg (Part A)Day 0n=8 Participants	800.13	267.63
Day 90n=6 Participants	821.33	235.97
Day 570n=3 Participants	803.00	7.55
PF-04360365 1.0 mg/kg (Part A)Day 0n=4 Participants	851.75	17.75
Day 90n=4 Participants	866.00	176.40
Day 570n=1 Participants	958.00	NA
Placebo (Part A)Day 0n=4 Participants	694.00	217.22
Day 90n=4 Participants	557.50	159.32
Day 570n=2 Participants	421.50	142.13
PF-04360365 3.0 mg/kg (Part B)Day 0n=13 Participants	959.54	281.30
Day 90n=11 Participants	949.36	223.50
Day 570n=9 Participants	487.11	483.28
PF-04360365 8.5 mg/kg (Part B)Day 0n=11 Participants	817.36	323.31
Day 90n=10 Participants	895.80	273.28
Day 570n=6 Participants	582.33	489.19
Placebo (Part B)Day 0n=17 Participants	803.41	232.38
Day 90n=14 Participants	778.29	221.01
Day 570n=8 Participants	665.25	358.57

Tau biomarkers

2 endpoints

Secondary/protocol endpoint

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

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Secondary/registry result

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

Time frame:Day 0 (Hour 0), 90, 570

concentration, descriptive

Posted result

Group	Value (mean), Picogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)Day 0: taun=3 Participants	188.90	118.60
Day 90: taun=3 Participants	202.33	112.51
Day 570: taun=1 Participants	78.00	NA
Day 0: p-taun=3 Participants	72.53	10.46
Day 90: p-taun=3 Participants	73.27	7.28
Day 570: p-taun=1 Participants	70.70	NA
PF-04360365 0.5 mg/kg (Part A)Day 0: taun=8 Participants	223.79	99.03
Day 90: taun=6 Participants	210.33	98.42
Day 570: taun=4 Participants	158.98	93.46
Day 0: p-taun=8 Participants	65.89	28.22
Day 90: p-taun=6 Participants	70.15	31.21
Day 570: p-taun=4 Participants	112.10	45.51
PF-04360365 1.0 mg/kg (Part A)Day 0: taun=4 Participants	190.43	102.86
Day 90: taun=4 Participants	167.78	83.20
Day 570: taun=2 Participants	90.80	28.57
Day 0: p-taun=4 Participants	49.13	13.83
Day 90: p-taun=4 Participants	64.50	30.38
Day 570: p-taun=2 Participants	76.45	50.28
Placebo (Part A)Day 0: taun=4 Participants	96.13	34.73
Day 90: taun=4 Participants	117.38	22.52
Day 570: taun=2 Participants	49.20	5.37
Day 0: p-taun=4 Participants	34.98	11.40
Day 90: p-taun=3 Participants	47.13	19.96
Day 570: p-taun=2 Participants	53.65	34.58
PF-04360365 3.0 mg/kg (Part B)Day 0: taun=13 Participants	219.09	192.54
Day 90: taun=10 Participants	217.64	149.25
Day 570: taun=8 Participants	166.18	115.72
Day 0: p-taun=13 Participants	56.72	30.64
Day 90: p-taun=10 Participants	60.26	36.98
Day 570: p-taun=8 Participants	54.43	31.79
PF-04360365 8.5 mg/kg (Part B)Day 0: taun=11 Participants	167.40	101.42
Day 90: taun=10 Participants	169.76	121.25
Day 570: taun=7 Participants	139.94	83.16
Day 0: p-taun=11 Participants	49.45	23.76
Day 90: p-taun=10 Participants	57.77	31.63
Day 570: p-taun=7 Participants	42.47	16.69
Placebo (Part B)Day 0: taun=17 Participants	196.31	147.04
Day 90: taun=13 Participants	158.00	62.91
Day 570: taun=8 Participants	124.24	51.28
Day 0: p-taun=17 Participants	59.17	28.41
Day 90: p-taun=13 Participants	47.98	16.91
Day 570: p-taun=8 Participants	53.59	32.04

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 24

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 24

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 24

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 0.1 mg/kg (Part A)Cerebral Edeman=25 Participants	0	-
Cerebral/Meningeal Enhancementn=25 Participants	0	-
Micro Hemorrhagen=25 Participants	4	-
Subdural Hematoman=25 Participants	0	-
Cortical Infarctsn=25 Participants	1	-
Subcortical Grey Matter Infarctsn=25 Participants	0	-
White Matter Infarctsn=25 Participants	0	-
White Matter Hyper Intensitiesn=25 Participants	0	-
Other Abnormalityn=25 Participants	12	-
PF-04360365 0.5 mg/kg (Part A)Cerebral Edeman=25 Participants	1	-
Cerebral/Meningeal Enhancementn=25 Participants	1	-
Micro Hemorrhagen=25 Participants	7	-
Subdural Hematoman=25 Participants	1	-
Cortical Infarctsn=25 Participants	0	-
Subcortical Grey Matter Infarctsn=25 Participants	0	-
White Matter Infarctsn=25 Participants	1	-
White Matter Hyper Intensitiesn=25 Participants	3	-
Other Abnormalityn=25 Participants	9	-
PF-04360365 1.0 mg/kg (Part A)Cerebral Edeman=25 Participants	0	-
Cerebral/Meningeal Enhancementn=25 Participants	0	-
Micro Hemorrhagen=25 Participants	2	-
Subdural Hematoman=25 Participants	0	-
Cortical Infarctsn=25 Participants	2	-
Subcortical Grey Matter Infarctsn=25 Participants	0	-
White Matter Infarctsn=25 Participants	0	-
White Matter Hyper Intensitiesn=25 Participants	2	-
Other Abnormalityn=25 Participants	8	-
Placebo (Part A)Cerebral Edeman=24 Participants	0	-
Cerebral/Meningeal Enhancementn=24 Participants	0	-
Micro Hemorrhagen=24 Participants	6	-
Subdural Hematoman=24 Participants	0	-
Cortical Infarctsn=24 Participants	0	-
Subcortical Grey Matter Infarctsn=24 Participants	0	-
White Matter Infarctsn=24 Participants	0	-
White Matter Hyper Intensitiesn=24 Participants	2	-
Other Abnormalityn=24 Participants	10	-
PF-04360365 3.0 mg/kg (Part B)Cerebral Edeman=31 Participants	0	-
Cerebral/Meningeal Enhancementn=31 Participants	0	-
Micro Hemorrhagen=31 Participants	3	-
Subdural Hematoman=31 Participants	0	-
Cortical Infarctsn=31 Participants	0	-
Subcortical Grey Matter Infarctsn=31 Participants	1	-
White Matter Infarctsn=31 Participants	0	-
White Matter Hyper Intensitiesn=31 Participants	4	-
Other Abnormalityn=31 Participants	8	-
PF-04360365 8.5 mg/kg (Part B)Cerebral Edeman=28 Participants	0	-
Cerebral/Meningeal Enhancementn=28 Participants	0	-
Micro Hemorrhagen=28 Participants	6	-
Subdural Hematoman=28 Participants	0	-
Cortical Infarctsn=28 Participants	1	-
Subcortical Grey Matter Infarctsn=28 Participants	1	-
White Matter Infarctsn=28 Participants	0	-
White Matter Hyper Intensitiesn=28 Participants	0	-
Other Abnormalityn=28 Participants	12	-
Placebo (Part B)Cerebral Edeman=32 Participants	0	-
Cerebral/Meningeal Enhancementn=32 Participants	0	-
Micro Hemorrhagen=32 Participants	6	-
Subdural Hematoman=32 Participants	0	-
Cortical Infarctsn=32 Participants	0	-
Subcortical Grey Matter Infarctsn=32 Participants	0	-
White Matter Infarctsn=32 Participants	2	-
White Matter Hyper Intensitiesn=32 Participants	2	-
Other Abnormalityn=32 Participants	10	-

Primary/registry result

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

Time frame:Baseline up to Month 24

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	3	-
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	1	-
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	2	-
Placebo (Part A)n=24 Participants	1	-
PF-04360365 3.0 mg/kg (Part B)n=31 Participants	1	-
PF-04360365 8.5 mg/kg (Part B)n=28 Participants	2	-
Placebo (Part B)n=32 Participants	3	-

Fluid / digital biomarkers

8 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

concentration, descriptive

Primary/protocol endpoint

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

Time frame:Day 90

concentration, descriptive

Primary/protocol endpoint

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570

Time frame:Day 570

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

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=3 Participants	0.00	0.00
PF-04360365 0.5 mg/kg (Part A)n=8 Participants	0.00	0.00
PF-04360365 1.0 mg/kg (Part A)n=4 Participants	0.00	0.00
PF-04360365 3.0 mg/kg (Part B)n=13 Participants	0.00	0.00
PF-04360365 8.5 mg/kg (Part B)n=11 Participants	0.00	0.00

Primary/registry result

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

Time frame:Day 90

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)CSFn=4 Participants	0.00	0.00
Plasman=25 Participants	286.20	133.25
PF-04360365 0.5 mg/kg (Part A)CSFn=6 Participants	0.00	0.00
Plasman=25 Participants	2074.48	558.85
PF-04360365 1.0 mg/kg (Part A)CSFn=5 Participants	6.36	14.22
Plasman=25 Participants	4277.88	1073.25
PF-04360365 3.0 mg/kg (Part B)CSFn=11 Participants	43.44	17.76
Plasman=30 Participants	16733.03	5624.57
PF-04360365 8.5 mg/kg (Part B)CSFn=10 Participants	157.40	85.17
Plasman=28 Participants	49141.68	11941.83

Primary/registry result

Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570

Time frame:Day 570

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)CSFn=2 Participants	0.00	0.00
Plasman=22 Participants	360.05	165.65
PF-04360365 0.5 mg/kg (Part A)CSFn=4 Participants	0.00	0.00
Plasman=21 Participants	2023.95	911.00
PF-04360365 1.0 mg/kg (Part A)CSFn=3 Participants	6.30	10.91
Plasman=18 Participants	4374.00	1465.99
PF-04360365 3.0 mg/kg (Part B)CSFn=10 Participants	56.77	23.14
Plasman=22 Participants	19638.68	8134.26
PF-04360365 8.5 mg/kg (Part B)CSFn=7 Participants	115.36	79.21
Plasman=22 Participants	44945.95	25370.94

Secondary/protocol endpoint

Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration

Time frame:Baseline up to Month 24

concentration, descriptive

Secondary/registry result

Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration

Time frame:Baseline up to Month 24

concentration, descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 0.1 mg/kg (Part A)CSF Protein (>ULN)n=4 Participants	1	-
CSF RBCs (>ULN)n=4 Participants	2	-
CSF WBCs (>ULN)n=4 Participants	0	-
CSF Glucose (>ULN)n=4 Participants	2	-
PF-04360365 0.5 mg/kg (Part A)CSF Protein (>ULN)n=6 Participants	3	-
CSF RBCs (>ULN)n=6 Participants	2	-
CSF WBCs (>ULN)n=6 Participants	0	-
CSF Glucose (>ULN)n=6 Participants	0	-
PF-04360365 1.0 mg/kg (Part A)CSF Protein (>ULN)n=5 Participants	1	-
CSF RBCs (>ULN)n=5 Participants	4	-
CSF WBCs (>ULN)n=5 Participants	0	-
CSF Glucose (>ULN)n=5 Participants	0	-
Placebo (Part A)CSF Protein (>ULN)n=5 Participants	3	-
CSF RBCs (>ULN)n=5 Participants	1	-
CSF WBCs (>ULN)n=5 Participants	0	-
CSF Glucose (>ULN)n=5 Participants	0	-
PF-04360365 3.0 mg/kg (Part B)CSF Protein (>ULN)n=11 Participants	4	-
CSF RBCs (>ULN)n=10 Participants	6	-
CSF WBCs (>ULN)n=11 Participants	2	-
CSF Glucose (>ULN)n=11 Participants	2	-
PF-04360365 8.5 mg/kg (Part B)CSF Protein (>ULN)n=10 Participants	4	-
CSF RBCs (>ULN)n=9 Participants	2	-
CSF WBCs (>ULN)n=9 Participants	0	-
CSF Glucose (>ULN)n=10 Participants	2	-
Placebo (Part B)CSF Protein (>ULN)n=14 Participants	4	-
CSF RBCs (>ULN)n=11 Participants	5	-
CSF WBCs (>ULN)n=14 Participants	0	-
CSF Glucose (>ULN)n=14 Participants	3	-

Safety / tolerability / PK

52 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, assessed up to Month 24

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 2 Hours on Day 1

Time frame:2 Hours on Day 1

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60

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

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60

Time frame:2 Hours on Day 60

concentration, descriptive

Primary/protocol endpoint

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

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

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120

Time frame:2 Hours on Day 120

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 on Day 150

Time frame:Day 150

concentration, descriptive

Primary/protocol endpoint

Mean Plasma 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 Concentration of PF-04360365 at 2 Hours on Day 180

Time frame:2 Hours on Day 180

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 on Day 210

Time frame:Day 210

concentration, descriptive

Primary/protocol endpoint

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

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

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240

Time frame:2 Hours on Day 240

concentration, descriptive

Primary/protocol endpoint

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

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

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300

Time frame:2 Hours on Day 300

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360

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

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360

Time frame:2 Hours on Day 360

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 on Day 390

Time frame:Day 390

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420

Time frame:0 Hour (pre-dose) on Day 420

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420

Time frame:2 Hours on Day 420

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480

Time frame:0 Hour (pre-dose) on Day 480

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480

Time frame:2 Hours on Day 480

concentration, descriptive

Primary/protocol endpoint

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

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

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540

Time frame:2 Hours on Day 540

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 on Day 660

Time frame:Day 660

concentration, descriptive

Primary/protocol endpoint

Mean Plasma Concentration of PF-04360365 on Day 720

Time frame:Day 720

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, assessed up to Month 24

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 0.1 mg/kg (Part A)AEsn=25 Participants	24	-
SAEsn=25 Participants	7	-
PF-04360365 0.5 mg/kg (Part A)AEsn=25 Participants	24	-
SAEsn=25 Participants	8	-
PF-04360365 1.0 mg/kg (Part A)AEsn=25 Participants	24	-
SAEsn=25 Participants	7	-
Placebo (Part A)AEsn=24 Participants	24	-
SAEsn=24 Participants	3	-
PF-04360365 3.0 mg/kg (Part B)AEsn=32 Participants	27	-
SAEsn=32 Participants	7	-
PF-04360365 8.5 mg/kg (Part B)AEsn=31 Participants	28	-
SAEsn=31 Participants	10	-
Placebo (Part B)AEsn=32 Participants	32	-
SAEsn=32 Participants	3	-

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), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	0.00	0.00
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	0.00	0.00
PF-04360365 1.0 mg/kg (Part A)n=24 Participants	14.25	69.81
PF-04360365 3.0 mg/kg (Part B)n=30 Participants	0.00	0.00
PF-04360365 8.5 mg/kg (Part B)n=30 Participants	38.10	208.68

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1

Time frame:2 Hours on Day 1

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=22 Participants	1731.36	605.07
PF-04360365 0.5 mg/kg (Part A)n=20 Participants	10051.85	1857.36
PF-04360365 1.0 mg/kg (Part A)n=23 Participants	21972.09	6582.50
PF-04360365 3.0 mg/kg (Part B)n=28 Participants	65832.36	23334.31
PF-04360365 8.5 mg/kg (Part B)n=27 Participants	187953.19	36763.80

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60

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

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	33.96	82.22
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	792.80	217.31
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	1747.04	311.05
PF-04360365 3.0 mg/kg (Part B)n=29 Participants	6715.34	3797.08
PF-04360365 8.5 mg/kg (Part B)n=29 Participants	30517.76	34018.99

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60

Time frame:2 Hours on Day 60

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=23 Participants	2018.13	402.12
PF-04360365 0.5 mg/kg (Part A)n=24 Participants	11372.46	2730.02
PF-04360365 1.0 mg/kg (Part A)n=24 Participants	23100.33	5598.52
PF-04360365 3.0 mg/kg (Part B)n=29 Participants	81464.62	25466.75
PF-04360365 8.5 mg/kg (Part B)n=23 Participants	209962.13	64637.17

Primary/registry result

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

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

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	106.08	116.00
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	1259.68	360.11
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	2573.64	622.86
PF-04360365 3.0 mg/kg (Part B)n=30 Participants	8781.20	3267.52
PF-04360365 8.5 mg/kg (Part B)n=27 Participants	31916.04	24631.87

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120

Time frame:2 Hours on Day 120

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=22 Participants	2083.14	549.16
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	12229.60	2813.13
PF-04360365 1.0 mg/kg (Part A)n=23 Participants	25263.43	6395.62
PF-04360365 3.0 mg/kg (Part B)n=27 Participants	69437.52	19262.08
PF-04360365 8.5 mg/kg (Part B)n=24 Participants	191019.54	65338.19

Primary/registry result

Mean Plasma Concentration of PF-04360365 on Day 150

Time frame:Day 150

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=24 Participants	344.17	157.08
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	2512.36	804.43
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	4673.32	932.48
PF-04360365 3.0 mg/kg (Part B)n=30 Participants	17636.10	6440.44
PF-04360365 8.5 mg/kg (Part B)n=27 Participants	53918.22	15265.59

Primary/registry result

Mean Plasma 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), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=24 Participants	114.71	137.86
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	1344.00	556.59
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	2819.68	819.68
PF-04360365 3.0 mg/kg (Part B)n=28 Participants	9885.71	3673.92
PF-04360365 8.5 mg/kg (Part B)n=26 Participants	30306.81	11823.33

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180

Time frame:2 Hours on Day 180

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=21 Participants	1959.05	650.77
PF-04360365 0.5 mg/kg (Part A)n=23 Participants	12096.22	3346.68
PF-04360365 1.0 mg/kg (Part A)n=23 Participants	24574.57	5989.22
PF-04360365 3.0 mg/kg (Part B)n=26 Participants	72597.58	13930.48
PF-04360365 8.5 mg/kg (Part B)n=23 Participants	194768.61	42953.08

Primary/registry result

Mean Plasma Concentration of PF-04360365 on Day 210

Time frame:Day 210

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=24 Participants	245.33	233.16
PF-04360365 0.5 mg/kg (Part A)n=24 Participants	2419.25	1034.32
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	4935.00	1349.38
PF-04360365 3.0 mg/kg (Part B)n=28 Participants	17973.43	6279.98
PF-04360365 8.5 mg/kg (Part B)n=27 Participants	55881.07	17445.49

Primary/registry result

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

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

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	170.64	389.00
PF-04360365 0.5 mg/kg (Part A)n=24 Participants	1423.83	582.13
PF-04360365 1.0 mg/kg (Part A)n=24 Participants	2782.17	1147.38
PF-04360365 3.0 mg/kg (Part B)n=27 Participants	11221.22	4030.07
PF-04360365 8.5 mg/kg (Part B)n=26 Participants	31093.81	11083.26

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240

Time frame:2 Hours on Day 240

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=21 Participants	1660.76	511.32
PF-04360365 0.5 mg/kg (Part A)n=22 Participants	10501.00	2550.48
PF-04360365 1.0 mg/kg (Part A)n=24 Participants	22340.46	5364.94
PF-04360365 3.0 mg/kg (Part B)n=25 Participants	80142.40	15093.45
PF-04360365 8.5 mg/kg (Part B)n=23 Participants	216585.87	32947.73

Primary/registry result

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

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

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=24 Participants	176.25	140.95
PF-04360365 0.5 mg/kg (Part A)n=22 Participants	1690.41	1585.87
PF-04360365 1.0 mg/kg (Part A)n=24 Participants	2958.13	1150.02
PF-04360365 3.0 mg/kg (Part B)n=26 Participants	11935.88	3779.50
PF-04360365 8.5 mg/kg (Part B)n=27 Participants	31766.30	12335.11

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300

Time frame:2 Hours on Day 300

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=24 Participants	1919.42	446.62
PF-04360365 0.5 mg/kg (Part A)n=20 Participants	10774.35	1736.85
PF-04360365 1.0 mg/kg (Part A)n=23 Participants	22273.26	6285.72
PF-04360365 3.0 mg/kg (Part B)n=24 Participants	76511.29	13832.35
PF-04360365 8.5 mg/kg (Part B)n=21 Participants	207292.95	50582.35

Primary/registry result

Mean Plasma 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), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=23 Participants	247.52	102.75
PF-04360365 0.5 mg/kg (Part A)n=21 Participants	1377.95	476.42
PF-04360365 1.0 mg/kg (Part A)n=23 Participants	3161.00	972.99
PF-04360365 3.0 mg/kg (Part B)n=26 Participants	10643.58	3986.99
PF-04360365 8.5 mg/kg (Part B)n=23 Participants	31485.52	12609.26

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360

Time frame:2 Hours on Day 360

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=22 Participants	2019.23	396.63
PF-04360365 0.5 mg/kg (Part A)n=19 Participants	11047.68	2232.06
PF-04360365 1.0 mg/kg (Part A)n=21 Participants	22833.43	4544.54
PF-04360365 3.0 mg/kg (Part B)n=24 Participants	71309.58	12691.07
PF-04360365 8.5 mg/kg (Part B)n=19 Participants	203124.84	35756.46

Primary/registry result

Mean Plasma Concentration of PF-04360365 on Day 390

Time frame:Day 390

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=22 Participants	411.00	195.94
PF-04360365 0.5 mg/kg (Part A)n=21 Participants	2344.76	780.92
PF-04360365 1.0 mg/kg (Part A)n=22 Participants	4902.36	1373.05
PF-04360365 3.0 mg/kg (Part B)n=26 Participants	18721.04	6458.67
PF-04360365 8.5 mg/kg (Part B)n=23 Participants	54956.65	20091.21

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420

Time frame:0 Hour (pre-dose) on Day 420

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=21 Participants	204.62	123.72
PF-04360365 0.5 mg/kg (Part A)n=21 Participants	1433.52	550.12
PF-04360365 1.0 mg/kg (Part A)n=21 Participants	3102.24	1146.00
PF-04360365 3.0 mg/kg (Part B)n=24 Participants	9711.42	3012.62
PF-04360365 8.5 mg/kg (Part B)n=21 Participants	30782.57	11295.55

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420

Time frame:2 Hours on Day 420

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=18 Participants	1919.50	600.41
PF-04360365 0.5 mg/kg (Part A)n=19 Participants	11513.89	1589.13
PF-04360365 1.0 mg/kg (Part A)n=18 Participants	23519.67	4499.54
PF-04360365 3.0 mg/kg (Part B)n=21 Participants	69975.00	16885.06
PF-04360365 8.5 mg/kg (Part B)n=16 Participants	196647.81	29248.03

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480

Time frame:0 Hour (pre-dose) on Day 480

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=23 Participants	162.52	161.33
PF-04360365 0.5 mg/kg (Part A)n=21 Participants	1480.95	557.75
PF-04360365 1.0 mg/kg (Part A)n=20 Participants	3125.25	1074.07
PF-04360365 3.0 mg/kg (Part B)n=24 Participants	10585.67	3272.66
PF-04360365 8.5 mg/kg (Part B)n=22 Participants	26612.45	12061.46

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480

Time frame:2 Hours on Day 480

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=21 Participants	1936.67	484.01
PF-04360365 0.5 mg/kg (Part A)n=19 Participants	11293.26	2237.99
PF-04360365 1.0 mg/kg (Part A)n=19 Participants	22930.21	4146.48
PF-04360365 3.0 mg/kg (Part B)n=21 Participants	67981.00	10368.30
PF-04360365 8.5 mg/kg (Part B)n=18 Participants	169955.72	35843.29

Primary/registry result

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

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

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=23 Participants	177.30	163.34
PF-04360365 0.5 mg/kg (Part A)n=19 Participants	1297.26	578.84
PF-04360365 1.0 mg/kg (Part A)n=16 Participants	2718.38	949.54
PF-04360365 3.0 mg/kg (Part B)n=23 Participants	10372.65	4310.28
PF-04360365 8.5 mg/kg (Part B)n=23 Participants	32303.09	35225.88

Primary/registry result

Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540

Time frame:2 Hours on Day 540

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=20 Participants	1981.20	591.23
PF-04360365 0.5 mg/kg (Part A)n=15 Participants	11291.40	2033.92
PF-04360365 1.0 mg/kg (Part A)n=15 Participants	20793.73	4168.51
PF-04360365 3.0 mg/kg (Part B)n=22 Participants	70660.14	16140.32
PF-04360365 8.5 mg/kg (Part B)n=18 Participants	178273.50	40289.00

Primary/registry result

Mean Plasma Concentration of PF-04360365 on Day 660

Time frame:Day 660

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=21 Participants	10.33	47.35
PF-04360365 0.5 mg/kg (Part A)n=18 Participants	480.78	303.49
PF-04360365 1.0 mg/kg (Part A)n=18 Participants	1212.22	596.19
PF-04360365 3.0 mg/kg (Part B)n=22 Participants	4196.50	2342.84
PF-04360365 8.5 mg/kg (Part B)n=21 Participants	7576.29	5013.34

Primary/registry result

Mean Plasma Concentration of PF-04360365 on Day 720

Time frame:Day 720

concentration, descriptive

Posted result

Group	Value (mean), Nanogram per milliliter	Standard deviation
PF-04360365 0.1 mg/kg (Part A)n=21 Participants	0.00	0.00
PF-04360365 0.5 mg/kg (Part A)n=20 Participants	198.70	206.30
PF-04360365 1.0 mg/kg (Part A)n=18 Participants	590.56	380.08
PF-04360365 3.0 mg/kg (Part B)n=23 Participants	1583.22	1163.66
PF-04360365 8.5 mg/kg (Part B)n=20 Participants	2795.30	1606.90

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Number of Participants With Serum Anti-Drug Anti Body (ADA)

Time frame:Day 1 up to Month 24

event count, event

Secondary/registry result/low confidence

Number of Participants With Serum Anti-Drug Anti Body (ADA)

Time frame:Day 1 up to Month 24

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PF-04360365 0.1 mg/kg (Part A)n=25 Participants	0	-
PF-04360365 0.5 mg/kg (Part A)n=25 Participants	0	-
PF-04360365 1.0 mg/kg (Part A)n=25 Participants	0	-
PF-04360365 3.0 mg/kg (Part B)n=32 Participants	0	-
PF-04360365 8.5 mg/kg (Part B)n=31 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.