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CompletedPhase 1Results posted

A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease

A PHASE 1, DOUBLE-BLIND, PLACEBO-CONTROLLED, SPONSOR OPEN, RANDOMIZED, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-04447943 IN MILD TO MODERATE ALZHEIMER'S DISEASE SUBJECTS ON STABLE DONEPEZIL THERAPY

Lead sponsor

Pfizer

Asset

PF-04447943

Listed sites

3

Recruiting sites

-

Enrollment

15

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE 18-26•Study partner/caregiver required•AD symptomatic therapy: stable

Primary endpoints

•Vital Signs Abnormalities of Potential Clinical Concern•Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern•Laboratory Test Abnormalities

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

Org study IDB0401008
NCT IDNCT00988598

Timeline

Milestones

Study first posted2009-10-02estimated
Study start2009-10-26actual
Primary completion2010-07-05actual
Study completion2010-07-05actual
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

•Subjects must have Alzheimer's dementia with a Mini Mental State Examination score between 18-26, inclusive.
•Subjects must have a reliable caregiver.
•Subjects must be on Aricept
•Memantine is allowed if subjects are on a stable dose
•Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG, with no serious or unstable disease within the past 3 months

Exclusion criteria

•Subjects with clinically significant heart disease cannot participate.
•Subjects with a past or current history of seizures cannot participate.

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

Safety / tolerability / PK
18
Other (unclassified)
6

Safety / tolerability / PK

18 endpoints
Primary/protocol endpoint

Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern

Time frame:Baseline up to Day 10

event count, event

Primary/protocol endpoint

Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern

Time frame:Baseline up to Day 10

event count, event

Primary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Baseline up to Day 10

event count, event

Primary/registry result

Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern

Time frame:Baseline up to Day 10

event count, event

Posted result

GroupValue (number), participantsReported bounds
PF-04447943 25 mg + DonepezilSupine Systolic BP (<90 mmHg)n=10 Participants0-
Standing Systolic BP (<90 mmHg)n=10 Participants0-
Supine Diastolic BP (<50 mmHg)n=10 Participants0-
Standing Diastolic BP (<50 mmHg)n=10 Participants0-
Max Increase in Supine Systolic BP (>=30 mmHg)n=10 Participants0-
Max Increase in Standing Systolic BP (>=30 mmHg)n=10 Participants0-
Max Increase in Supine Diastolic BP (>=20 mmHg)n=10 Participants1-
Max Increase in Standing Diastolic BP (>=20 mmHg)n=10 Participants0-
Max Decrease in Supine Systolic BP (>=30 mmHg)n=10 Participants2-
Max Decrease in Standing Systolic BP (>=30 mmHg)n=10 Participants2-
Max Decrease in Supine Diastolic BP (>=20 mmHg)n=10 Participants0-
Max Decrease in Standing Diastolic BP (>=20 mmHg)n=10 Participants0-
Supine Pulse Rate (<40 bpm)n=10 Participants0-
Supine Pulse Rate (>120 bpm)n=10 Participants0-
Standing Pulse Rate (<40 bpm)n=10 Participants0-
Standing Pulse Rate (>140 bpm)n=10 Participants0-
Placebo + DonepezilSupine Systolic BP (<90 mmHg)n=5 Participants0-
Standing Systolic BP (<90 mmHg)n=5 Participants0-
Supine Diastolic BP (<50 mmHg)n=5 Participants0-
Standing Diastolic BP (<50 mmHg)n=5 Participants0-
Max Increase in Supine Systolic BP (>=30 mmHg)n=5 Participants2-
Max Increase in Standing Systolic BP (>=30 mmHg)n=5 Participants2-
Max Increase in Supine Diastolic BP (>=20 mmHg)n=5 Participants1-
Max Increase in Standing Diastolic BP (>=20 mmHg)n=5 Participants1-
Max Decrease in Supine Systolic BP (>=30 mmHg)n=5 Participants1-
Max Decrease in Standing Systolic BP (>=30 mmHg)n=5 Participants1-
Max Decrease in Supine Diastolic BP (>=20 mmHg)n=5 Participants1-
Max Decrease in Standing Diastolic BP (>=20 mmHg)n=5 Participants0-
Supine Pulse Rate (<40 bpm)n=5 Participants0-
Supine Pulse Rate (>120 bpm)n=5 Participants0-
Standing Pulse Rate (<40 bpm)n=5 Participants0-
Standing Pulse Rate (>140 bpm)n=5 Participants0-
Primary/registry result

Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern

Time frame:Baseline up to Day 10

event count, event

Posted result

GroupValue (number), participantsReported bounds
PF-04447943 25 mg + DonepezilMaximum PR Interval (>=300 msec)n=10 Participants0-
Maximum PR Interval Increase (>=25/50%)n=10 Participants0-
Maximum QRS Interval (>=200 msec)n=10 Participants0-
Maximum QRS Interval Increase (>=25/50%)n=10 Participants0-
Maximum QTcF Interval (>=500 msec)n=10 Participants0-
Maximum QTcF Interval Increase(Change >=30 to <60)n=10 Participants2-
Maximum QTcF Interval Increase (Change >=60)n=10 Participants0-
Placebo + DonepezilMaximum PR Interval (>=300 msec)n=5 Participants0-
Maximum PR Interval Increase (>=25/50%)n=5 Participants0-
Maximum QRS Interval (>=200 msec)n=5 Participants0-
Maximum QRS Interval Increase (>=25/50%)n=5 Participants0-
Maximum QTcF Interval (>=500 msec)n=5 Participants0-
Maximum QTcF Interval Increase(Change >=30 to <60)n=5 Participants1-
Maximum QTcF Interval Increase (Change >=60)n=5 Participants0-
Primary/registry result

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Baseline up to Day 10

event count, event

Posted result

GroupValue (number), participantsReported bounds
PF-04447943 25 mg + DonepezilAEsn=10 Participants6-
SAEsn=10 Participants0-
Placebo + DonepezilAEsn=5 Participants0-
SAEsn=5 Participants0-
Secondary/protocol endpoint

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

time to event, event

Secondary/protocol endpoint

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax) of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

time to event, event

Secondary/registry result

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hour per milliliter (ng*hr/mL)Standard deviation
PF-04447943 25 mg + DonepezilDay 1n=10 Participants1657391.88
Day 7n=8 Participants2140688.96
Secondary/registry result

Maximum Observed Plasma Concentration (Cmax) of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mLStandard deviation
PF-04447943 25 mg + DonepezilDay 1n=10 Participants303.866.655
Day 7n=8 Participants390.9109.31
Secondary/registry result

Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

time to event, event

Posted result

GroupValue (median), hoursReported bounds
PF-04447943 25 mg + DonepezilDay 1n=10 Participants1.00-1.00 - 3.00
Day 7n=8 Participants0.767-0.500 - 3.00
Secondary/registry result

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng*hr/mLStandard deviation
PF-04447943 25 mg + DonepezilDay 0n=10 Participants426.8256.08
Day 7n=8 Participants513.4314.66
Placebo + DonepezilDay 0n=5 Participants380.6127.02
Day 7n=5 Participants565.240.402
Secondary/registry result

Maximum Observed Plasma Concentration (Cmax) of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mLStandard deviation
PF-04447943 25 mg + DonepezilDay 0n=10 Participants47.6027.600
Day 7n=8 Participants52.8830.177
Placebo + DonepezilDay 0n=5 Participants42.488.1522
Day 7n=5 Participants59.614.6404
Secondary/registry result

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

time to event, event

Posted result

GroupValue (median), hoursReported bounds
PF-04447943 25 mg + DonepezilDay 0n=10 Participants3.00-1.00 - 3.00
Day 7n=8 Participants3.00-1.00 - 8.00
Placebo + DonepezilDay 0n=5 Participants3.00-1.00 - 3.02
Day 7n=5 Participants3.00-1.00 - 3.00

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Number of Participants With Laboratory Test Abnormalities

Time frame:Baseline up to Day 10

event count, event

Primary/registry result/low confidence

Number of Participants With Laboratory Test Abnormalities

Time frame:Baseline up to Day 10

event count, event

Posted result

GroupValue (number), participantsReported bounds
PF-04447943 25 mg + Donepeziln=10 Participants4-
Placebo + Donepeziln=5 Participants4-
Secondary/protocol endpoint/low confidence

Plasma Concentrations of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

concentration, descriptive

Secondary/protocol endpoint/low confidence

Plasma Concentrations of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

concentration, descriptive

Secondary/registry result/low confidence

Plasma Concentrations of PF-04447943

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7

concentration, descriptive

Posted result

GroupValue (mean), nanogram per milliliter (ng/mL)Standard deviation
PF-04447943 25 mg + DonepezilDay 1: 0 hoursn=10 Participants0.010500.033204
Day 1: 0.5 hoursn=10 Participants179.6127.67
Day 1: 1 hourn=10 Participants296.783.312
Day 1: 3 hoursn=10 Participants225.946.905
Day 1: 8 hoursn=10 Participants91.7630.400
Day 1: 12 hoursn=10 Participants51.9921.018
Day 7: 0 hoursn=8 Participants73.4928.023
Day 7: 0.5 hoursn=8 Participants340.4168.41
Day 7: 1 hourn=8 Participants353.6112.63
Day 7: 3 hoursn=8 Participants284.083.881
Day 7: 8 hoursn=8 Participants124.849.247
Day 7: 12 hoursn=8 Participants69.0828.483
Secondary/registry result/low confidence

Plasma Concentrations of Donepezil

Time frame:0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7

concentration, descriptive

Posted result

GroupValue (mean), ng/mLStandard deviation
PF-04447943 25 mg + DonepezilDay 0: 0 hoursn=10 Participants29.3022.982
Day 0: 0.5 hoursn=10 Participants29.9322.874
Day 0: 1 hourn=10 Participants41.0820.592
Day 0: 3 hoursn=10 Participants54.0928.122
Day 0: 8 hoursn=10 Participants42.1524.360
Day 0: 12 hoursn=9 Participants34.0420.659
Day 7: 0 hoursn=8 Participants34.9422.579
Day 7: 0.5 hoursn=8 Participants39.5626.766
Day 7: 1 hourn=8 Participants47.2930.726
Day 7: 3 hoursn=8 Participants58.1530.916
Day 7: 8 hoursn=8 Participants46.9023.802
Day 7: 12 hoursn=8 Participants42.8323.299
Placebo + DonepezilDay 0: 0 hoursn=5 Participants19.1010.562
Day 0: 0.5 hoursn=5 Participants23.9216.478
Day 0: 1 hourn=5 Participants36.189.6916
Day 0: 3 hoursn=5 Participants41.5611.088
Day 0: 8 hoursn=5 Participants30.9211.339
Day 0: 12 hoursn=5 Participants28.0211.308
Day 7: 0 hoursn=5 Participants33.863.7031
Day 7: 0.5 hoursn=5 Participants35.823.8226
Day 7: 1 hourn=5 Participants45.0412.347
Day 7: 3 hoursn=5 Participants56.365.6783
Day 7: 8 hoursn=5 Participants45.424.4404
Day 7: 12 hoursn=5 Participants41.784.7505

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.