A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

NCT ID: NCT00141661

Last Updated: 2009-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-06-30

Brief Summary

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A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.

Detailed Description

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Conditions

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Alzheimer Disease

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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Low Dose Arm

Group Type EXPERIMENTAL

PF-04494700 - Low Dose Arm

Intervention Type DRUG

30 mg loading dose for 6 days, followed by 10 mg daily

High Dose Arm

Group Type EXPERIMENTAL

PF-04494700 - High Dose Arm

Intervention Type DRUG

60 mg loading dose for 6 days, followed by 20 mg daily

Placebo Control

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Matching placebo.

Interventions

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PF-04494700 - Low Dose Arm

30 mg loading dose for 6 days, followed by 10 mg daily

Intervention Type DRUG

PF-04494700 - High Dose Arm

60 mg loading dose for 6 days, followed by 20 mg daily

Intervention Type DRUG

Placebo Comparator

Matching placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of probably Alzheimer's disease for at least 1 year.
* Mini Mental State Exam (MMSE) score between 12-26 at screening.
* Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.

Exclusion Criteria

* Current evidence of a neurological or psychiatric illness that could contribute to dementia.
* Living alone.
* Poorly controlled high blood pressure.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trans Tech Pharmaceuticals

UNKNOWN

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Sun City, Arizona, United States

Site Status

Pfizer Investigational Site

Fresno, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

San Francisco, California, United States

Site Status

Pfizer Investigational Site

Fort Lauderdale, Florida, United States

Site Status

Pfizer Investigational Site

Fort Myers, Florida, United States

Site Status

Pfizer Investigational Site

Hallandale, Florida, United States

Site Status

Pfizer Investigational Site

Jacksonville, Florida, United States

Site Status

Pfizer Investigational Site

Largo, Florida, United States

Site Status

Pfizer Investigational Site

Orlando, Florida, United States

Site Status

Pfizer Investigational Site

West Palm Beach, Florida, United States

Site Status

Pfizer Investigational Site

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

Other Identifiers

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TTP488-201

Identifier Type: -

Identifier Source: secondary_id

B0341008

Identifier Type: -

Identifier Source: org_study_id

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