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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: PF-04494700; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00566397

B0341002

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.

Enrollment: 402 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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402 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: PF-04494700

Drug: PF-04494700

2

Experimental group

Treatment:

Drug: PF-04494700

Drug: PF-04494700

3

Placebo Comparator group

Treatment:

Drug: Placebo