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

NCT ID: NCT00988598

Last Updated: 2020-11-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-26

Study Completion Date

2010-07-05

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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phase 1 Alzheimer's disease donepezil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-04447943

Group Type ACTIVE_COMPARATOR

PF-04447943

Intervention Type DRUG

25 mg of PF-04447943 orally every 12 hours for 7 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days

Interventions

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PF-04447943

25 mg of PF-04447943 orally every 12 hours for 7 days

Intervention Type DRUG

Placebo

25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Glendale Adventist Medical Center

Glendale, California, United States

Site Status

University of Florida - Center for Clinical Trials Research

Gainesville, Florida, United States

Site Status

MD Clinical

Hallandale, Florida, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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B0401008

Identifier Type: -

Identifier Source: org_study_id