A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

June 28, 2010 updated by: Pfizer

A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild-to-Moderate Alzheimer's disease
  • MMSE score 10-24 inclusive

Exclusion Criteria:

  • Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days
  • Complication of other causes of dementia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo three times daily for 6 months
Drug: Placebo
Placebo three times daily for 6 months
Experimental: PF-01913539 5 mg three times daily
PF-01913539 5 mg three times daily for 6 months
Drug: PF-01913539 5 mg
PF-01913539 5 mg three times daily for 6 months
Experimental: PF-01913539 20 mg three times daily
PF-01913539 20 mg three times daily for 6 months
Drug: PF-01913539 5 mg
PF-01913539 5 mg three times daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
Time Frame: 26 weeks
26 weeks
Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.
Time Frame: 12, 26 weeks
12, 26 weeks
Mean change in Neuropsychiatric Inventory (NPI) score from baseline.
Time Frame: 12, 26 weeks
12, 26 weeks
Mean change in Mini-Mental State Examination (MMSE) score from baseline.
Time Frame: 6, 12, 18, 26 weeks
6, 12, 18, 26 weeks
Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.
Time Frame: 12, 26 weeks
12, 26 weeks
Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).
Time Frame: 12, 26 weeks
12, 26 weeks
Population PK parameters (CL/F, V/F, etc.)
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 29, 2010

Last Update Submitted That Met QC Criteria

June 28, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1451010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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