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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: PF-04447943; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988598

B0401008

Details and patient eligibility

About

The purpose of the study is to evaluate the safety of PF-04447943 when given in combination with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the absorption and distribution of both PF-04447943 and donepezil.

Enrollment: 15 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

PF-04447943

Active Comparator group

Treatment:

Drug: PF-04447943

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo