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

NCT ID: NCT01066481

Last Updated: 2010-06-29

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Alzheimer's Disease Dementia Dimebon Investigational Drug

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-01913539 5 mg three times daily

PF-01913539 5 mg three times daily for 6 months

Group Type EXPERIMENTAL

PF-01913539 5 mg

Intervention Type DRUG

PF-01913539 5 mg three times daily for 6 months

PF-01913539 20 mg three times daily

PF-01913539 20 mg three times daily for 6 months

Group Type EXPERIMENTAL

PF-01913539 5 mg

Intervention Type DRUG

PF-01913539 5 mg three times daily for 6 months

Placebo

Placebo three times daily for 6 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo three times daily for 6 months

Interventions

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PF-01913539 5 mg

PF-01913539 5 mg three times daily for 6 months

Intervention Type DRUG

PF-01913539 5 mg

PF-01913539 5 mg three times daily for 6 months

Intervention Type DRUG

Placebo

Placebo three times daily for 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

Related Links

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Other Identifiers

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B1451010

Identifier Type: -

Identifier Source: org_study_id

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