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CompletedPhase 2Results posted

A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease

A PHASE 2 MULTICENTER, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF PF-04447943 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

Lead sponsor

Pfizer

Asset

PF-04447943

Listed sites

44

Recruiting sites

-

Enrollment

191

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 14-26

Primary endpoint

•ADAS-Cog

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 number2009-012179-82
Org study IDB0401005
NCT IDNCT00930059

Timeline

Milestones

Study first posted2009-06-30estimated
Study start2009-09-10actual
Primary completion2010-09-22actual
Study completion2010-09-22actual
Last update posted2020-11-19actual
Results first posted2020-11-19actual

Assets

Drug assets

PF-04447943

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Mild to moderate Alzheimer's disease (MMSE 14-26)
•Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)

Exclusion criteria

•Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
•Significant cardiovascular disease in the past 6 months
•Illness other than Alzheimer's disease that could contribute to cognitive impairment
•History of stroke or seizure disorder

Endpoints (24)

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

Global cognition
8
Safety / tolerability / PK
6
Behavior / neuropsychiatric
4
Other (unclassified)
4
Other clinical outcomes
2

Global cognition

8 endpoints
Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline

Time frame:Baseline (Day 1)

ADAS-Cog

descriptive

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Primary/registry result

Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline

Time frame:Baseline (Day 1)

ADAS-Cog

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Placebon=100 Participants21.8710.42
PF-04447943n=91 Participants22.6610.39
Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12

Time frame:Baseline, Week 12

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), units on a scaleStandard error
Placebon=93 Participants-1.600.50
PF-04447943n=80 Participants-1.910.54
LS mean difference-0.3190% CI-1.52 - 0.90p0.3353ANCOVA
Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9

Time frame:Baseline, Week 3, 6, 9

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9

Time frame:Baseline, Week 3, 6, 9

ADAS-Cog

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), units on a scaleStandard error
PlaceboChange at Week 3n=100 Participants-1.360.49
Change at Week 6n=96 Participants-1.170.50
Change at Week 9n=97 Participants-2.050.50
PF-04447943Change at Week 3n=89 Participants-1.160.52
Change at Week 6n=83 Participants-1.530.53
Change at Week 9n=82 Participants-2.680.53
LS mean difference0.2090% CI-0.99 - 1.38p0.6073ANCOVA
LS mean difference-0.3690% CI-1.56 - 0.84p0.3086ANCOVA
LS mean difference-0.6290% CI-1.82 - 0.58p0.1970ANCOVA
Other/protocol endpoint

Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Screening, Baseline, Post-baseline (Week 1 up to 12)

event count, event

Other_pre_specified/registry result

Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame:Screening, Baseline, Post-baseline (Week 1 up to 12)

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
PlaceboSuicidal behavior: Screeningn=100 Participants0-
Suicide attempt: Screeningn=100 Participants0-
Interrupted attempt: Screeningn=100 Participants0-
Aborted attempt: Screeningn=100 Participants0-
Imminent suicidal behavior: Screeningn=100 Participants0-
Suicidal ideation: Screeningn=100 Participants5-
Non-suicidal SIB: Screeningn=100 Participants0-
Suicidal behavior: Baselinen=100 Participants0-
Suicide attempt: Baselinen=100 Participants0-
Interrupted Attempt: Baselinen=100 Participants0-
Aborted attempt: Baselinen=100 Participants0-
Imminent suicidal behavior: Baselinen=100 Participants0-
Suicidal ideation: Baselinen=100 Participants4-
Non-Suicidal SIB: Baselinen=100 Participants0-
Suicidal behavior: Post baselinen=100 Participants0-
Suicide attempt: Post baselinen=100 Participants0-
Interrupted attempt: Post baselinen=100 Participants0-
Aborted attempt: Post baselinen=100 Participants0-
Imminent suicidal behavior:Post baselinen=100 Participants0-
Suicidal ideation: Post baselinen=100 Participants6-
Non-suicidal SIB: Post baselinen=100 Participants0-
PF-04447943Suicidal behavior: Screeningn=91 Participants0-
Suicide attempt: Screeningn=91 Participants0-
Interrupted attempt: Screeningn=91 Participants0-
Aborted attempt: Screeningn=91 Participants0-
Imminent suicidal behavior: Screeningn=91 Participants0-
Suicidal ideation: Screeningn=91 Participants6-
Non-suicidal SIB: Screeningn=91 Participants0-
Suicidal behavior: Baselinen=91 Participants0-
Suicide attempt: Baselinen=91 Participants0-
Interrupted Attempt: Baselinen=91 Participants0-
Aborted attempt: Baselinen=91 Participants0-
Imminent suicidal behavior: Baselinen=91 Participants0-
Suicidal ideation: Baselinen=91 Participants5-
Non-Suicidal SIB: Baselinen=91 Participants0-
Suicidal behavior: Post baselinen=89 Participants0-
Suicide attempt: Post baselinen=89 Participants0-
Interrupted attempt: Post baselinen=89 Participants0-
Aborted attempt: Post baselinen=89 Participants0-
Imminent suicidal behavior:Post baselinen=89 Participants0-
Suicidal ideation: Post baselinen=89 Participants6-
Non-suicidal SIB: Post baselinen=89 Participants1-

Behavior / neuropsychiatric

4 endpoints
Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI) Total Score at Baseline

Time frame:Baseline

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12

Time frame:Baseline, Week 3, 6, 9, 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Neuropsychiatric Inventory (NPI) Total Score at Baseline

Time frame:Baseline

Neuropsychiatric Inventory (NPI)

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Placebon=100 Participants12.1612.86
PF-04447943n=91 Participants10.6711.28
Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12

Time frame:Baseline, Week 3, 6, 9, 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), units on a scaleStandard error
PlaceboChange at Week 3n=100 Participants-2.020.66
Change at Week 6n=97 Participants-2.610.66
Change at Week 9n=97 Participants-3.440.66
Change at Week 12n=93 Participants-2.700.67
PF-04447943Change at Week 3n=89 Participants-1.330.70
Change at Week 6n=84 Participants-1.760.71
Change at Week 9n=82 Participants-2.490.72
Change at Week 12n=80 Participants-2.860.72
LS mean difference0.6990% CI-0.89 - 2.27p0.7634ANCOVA
LS mean difference0.8590% CI-0.75 - 2.45p0.8077ANCOVA
LS mean difference0.9690% CI-0.66 - 2.57p0.8350ANCOVA
LS mean difference-0.1690% CI-1.78 - 1.48p0.4377ANCOVA

Safety / tolerability / PK

6 endpoints
Other/protocol endpoint

Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities

Time frame:Baseline up to Week 12

event count, event

Other/protocol endpoint

PF-04447943 Plasma Concentration

Time frame:Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12

concentration, descriptive

Other/protocol endpoint

Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities

Time frame:Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension

event count, event

Other_pre_specified/registry result

Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities

Time frame:Baseline up to Week 12

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
PlaceboPR interval >=300 msecn=99 Participants0-
PR interval: 25% or 50% increasen=94 Participants0-
QRS complex >=200 msecn=99 Participants0-
QRS interval: >=25% or 50% increasen=95 Participants1-
QT interval >=500 msecn=99 Participants2-
QTcB interval: 450 to < 480 msecn=99 Participants19-
QTcB interval: 480 to < 500 msecn=99 Participants4-
QTcB interval >= 500 msecn=99 Participants0-
QTcB interval: 30 to <60 msec increasen=95 Participants11-
QTcB interval: >=60 msec increasen=95 Participants0-
QTcF interval: 450 to <480 msecn=99 Participants9-
QTcF interval: 480 to <500 msecn=99 Participants4-
QTcF Interval >= 500 msecn=99 Participants0-
QTcF interval: 30 to <60 msec increasen=95 Participants6-
QTcF interval: >=60 msec increasen=95 Participants2-
PF-04447943PR interval >=300 msecn=88 Participants0-
PR interval: 25% or 50% increasen=83 Participants0-
QRS complex >=200 msecn=91 Participants1-
QRS interval: >=25% or 50% increasen=87 Participants1-
QT interval >=500 msecn=91 Participants1-
QTcB interval: 450 to < 480 msecn=91 Participants22-
QTcB interval: 480 to < 500 msecn=91 Participants1-
QTcB interval >= 500 msecn=91 Participants3-
QTcB interval: 30 to <60 msec increasen=86 Participants13-
QTcB interval: >=60 msec increasen=86 Participants1-
QTcF interval: 450 to <480 msecn=91 Participants12-
QTcF interval: 480 to <500 msecn=91 Participants0-
QTcF Interval >= 500 msecn=91 Participants3-
QTcF interval: 30 to <60 msec increasen=86 Participants10-
QTcF interval: >=60 msec increasen=86 Participants1-
Other_pre_specified/registry result

PF-04447943 Plasma Concentration

Time frame:Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12

concentration, descriptive

Posted result

GroupValue (median), nanogram per milliliterReported bounds
PlaceboWeek 1n=1 ParticipantsNA-NA - NA
Week 3n=1 ParticipantsNA-NA - NA
Week 6n=1 ParticipantsNA-NA - NA
Week 9n=90 Participants0.0000-0.0 - 40.6
Week 12n=1 ParticipantsNA-NA - NA
PF-04447943Week 1n=79 Participants71.60-0.000 - 407
Week 3n=80 Participants241.0-0.000 - 561
Week 6n=79 Participants225.0-0.000 - 693
Week 9n=80 Participants239.5-0.000 - 738
Week 12n=80 Participants250.5-0.000 - 598
Other_pre_specified/registry result

Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities

Time frame:Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
PlaceboIncrease in supine SBP (>=30 mmHg)n=100 Participants9-
Decrease in supine SBP (>=30 mmHg)n=100 Participants5-
Increase in standing SBP (>=30 mmHg)n=100 Participants6-
Decrease in Standing SBP (>=30 mmHg)n=100 Participants11-
Increase in supine DBP (>=20 mmHg)n=100 Participants3-
Decrease in Supine DBP (>=20 mmHg) (n=100 Participants9-
Increase in standing DBP(>=20 mmHg)n=100 Participants4-
Decrease in Standing DBP(>=20 mmHg)n=100 Participants4-
Orthostatic Hypotension: Week 1n=100 Participants5-
Orthostatic Hypotension: Week 3n=100 Participants3-
Orthostatic Hypotension: Week 6n=100 Participants4-
Orthostatic Hypotension: Week 9n=100 Participants2-
Orthostatic Hypotension: Week 12n=100 Participants5-
PF-04447943Increase in supine SBP (>=30 mmHg)n=89 Participants4-
Decrease in supine SBP (>=30 mmHg)n=89 Participants8-
Increase in standing SBP (>=30 mmHg)n=88 Participants7-
Decrease in Standing SBP (>=30 mmHg)n=88 Participants9-
Increase in supine DBP (>=20 mmHg)n=89 Participants2-
Decrease in Supine DBP (>=20 mmHg) (n=89 Participants8-
Increase in standing DBP(>=20 mmHg)n=88 Participants3-
Decrease in Standing DBP(>=20 mmHg)n=88 Participants6-
Orthostatic Hypotension: Week 1n=91 Participants3-
Orthostatic Hypotension: Week 3n=91 Participants3-
Orthostatic Hypotension: Week 6n=91 Participants2-
Orthostatic Hypotension: Week 9n=91 Participants4-
Orthostatic Hypotension: Week 12n=91 Participants4-

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Clinical Global Impression - Improvement (CGI-I)

Time frame:Week 3, 6, 9, 12

descriptive

Secondary/registry result

Clinical Global Impression - Improvement (CGI-I)

Time frame:Week 3, 6, 9, 12

descriptive

Posted result

GroupValue (least_squares_mean), units on a scaleStandard error
PlaceboWeek 3n=100 Participants3.640.10
Week 6n=96 Participants3.510.10
Week 9n=97 Participants3.630.10
Week 12n=93 Participants3.530.10
PF-04447943Week 3n=89 Participants3.700.10
Week 6n=84 Participants3.580.11
Week 9n=82 Participants3.450.11
Week 12n=80 Participants3.320.11
LS mean difference0.0690% CI-0.18 - 0.29p0.6547Linear model

Week 3: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.

LS mean difference0.0890% CI-0.16 - 0.31p0.7020Linear model

Week 6: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.

LS mean difference-0.1790% CI-0.41 - 0.06p0.1138Linear model

Week 9: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.

LS mean difference-0.2090% CI-0.44 - 0.04p0.0816Linear model

Week 12: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.

Other (unclassified)

4 endpoints
Other/protocol endpoint/low confidence

Number of Participants With Laboratory Test Abnormalities

Time frame:Baseline up to Week 12

event count, event

Other/protocol endpoint/low confidence

Number of Participants With Abnormal Physical Examinations and Neurological Examinations

Time frame:Screening (28 days before Baseline), Week 12

event count, event

Other_pre_specified/registry result/low confidence

Number of Participants With Laboratory Test Abnormalities

Time frame:Baseline up to Week 12

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
Placebon=99 Participants33-
PF-04447943n=88 Participants28-
Other_pre_specified/registry result/low confidence

Number of Participants With Abnormal Physical Examinations and Neurological Examinations

Time frame:Screening (28 days before Baseline), Week 12

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
PlaceboAbdomen: Screeningn=100 Participants9-
Abdomen: Week 12n=96 Participants5-
Ears: Screeningn=99 Participants6-
Ears: Week 12n=95 Participants3-
Extremities: Screeningn=98 Participants15-
Extremities: Week 12n=95 Participants10-
Eyes: Screeningn=100 Participants26-
Eyes: Week 12n=96 Participants24-
General: Screeningn=100 Participants1-
General: Week 12n=96 Participants2-
Head: Screeningn=99 Participants1-
Head: Week 12n=95 Participants1-
Heart: Screeningn=100 Participants3-
Heart: Week 12n=96 Participants3-
Lungs: Screeningn=100 Participants3-
Lungs: Week 12n=96 Participants3-
Lymph nodes: Screeningn=92 Participants0-
Lymph nodes: Week 12n=96 Participants0-
Mouth: Screeningn=100 Participants11-
Mouth: Week 12n=96 Participants9-
Musculoskeletal: Screeningn=99 Participants11-
Musculoskeletal: Week 12n=96 Participants7-
Neck: Screeningn=100 Participants1-
Neck: Week 12n=96 Participants0-
Nose: Screeningn=98 Participants0-
Nose: Week 12n=95 Participants0-
Ocular fundi: Screeningn=85 Participants1-
Ocular fundi: Week 12n=85 Participants1-
Pulses: Screeningn=97 Participants2-
Pulses: Week 12n=96 Participants0-
Skin: Screeningn=100 Participants30-
Skin: Week 12n=95 Participants25-
Throat: Screeningn=99 Participants0-
Throat: Week 12n=96 Participants0-
Thyroid: Screeningn=100 Participants0-
Thyroid: Week 12n=96 Participants0-
Other: Screeningn=25 Participants2-
Other: Week 12n=13 Participants0-
PF-04447943Abdomen: Screeningn=89 Participants9-
Abdomen: Week 12n=86 Participants6-
Ears: Screeningn=91 Participants9-
Ears: Week 12n=86 Participants9-
Extremities: Screeningn=86 Participants15-
Extremities: Week 12n=86 Participants11-
Eyes: Screeningn=91 Participants26-
Eyes: Week 12n=86 Participants22-
General: Screeningn=91 Participants2-
General: Week 12n=86 Participants2-
Head: Screeningn=91 Participants1-
Head: Week 12n=86 Participants1-
Heart: Screeningn=90 Participants8-
Heart: Week 12n=86 Participants5-
Lungs: Screeningn=91 Participants0-
Lungs: Week 12n=86 Participants0-
Lymph nodes: Screeningn=84 Participants0-
Lymph nodes: Week 12n=85 Participants1-
Mouth: Screeningn=90 Participants3-
Mouth: Week 12n=86 Participants3-
Musculoskeletal: Screeningn=91 Participants13-
Musculoskeletal: Week 12n=86 Participants12-
Neck: Screeningn=91 Participants2-
Neck: Week 12n=86 Participants0-
Nose: Screeningn=91 Participants2-
Nose: Week 12n=86 Participants1-
Ocular fundi: Screeningn=73 Participants2-
Ocular fundi: Week 12n=75 Participants0-
Pulses: Screeningn=90 Participants3-
Pulses: Week 12n=86 Participants0-
Skin: Screeningn=91 Participants23-
Skin: Week 12n=86 Participants21-
Throat: Screeningn=91 Participants0-
Throat: Week 12n=86 Participants0-
Thyroid: Screeningn=88 Participants3-
Thyroid: Week 12n=85 Participants3-
Other: Screeningn=24 Participants1-
Other: Week 12n=17 Participants3-

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.