CompletedPhase 2

A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

PF-04494700

Listed sites

Recruiting sites

Enrollment

402

actual

Study population

Alzheimer’s disease

Key I/E criteria

•MMSE 14-26•AD symptomatic therapy: stable ≥4 months

Primary endpoints

•Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline•Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse

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 IDB0341002

NCT IDNCT00566397

Timeline

Milestones

Study start2007-12 (month precision)

Study first posted2007-12-03estimated

Primary completion2010-12actual (month precision)

Study completion2010-12actual (month precision)

Last update posted2018-11-30actual

Assets

Drug assets

PF-04494700

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.

•Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization

Exclusion criteria

•Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.

•Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.

•Evidence or history of diabetes mellitus Type 1 or Type 2.

•History or symptoms of autoimmune disorders.

Endpoints (5)

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

Amyloid biomarkers

Neuroimaging

Safety / tolerability / PK

Other (unclassified)

Global cognition

1 endpoint

Primary/protocol endpoint

Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.

Time frame:18 Month

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)

Time frame:18 Month

descriptive

Neuroimaging

1 endpoint

Primary/protocol endpoint

Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).

Time frame:18 Month

event count, event

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints

Time frame:18 Month

descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Evaluate the potential dose response of PF 04494700

Time frame:18 Month

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.