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An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease

NCT ID: NCT01066546

Last Updated: 2012-10-02

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe Alzheimer's Disease.

Detailed Description

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This study was terminated on May 7, 2010 due to modification of the dimebon development plan, following the lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well-tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Conditions

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Alzheimer's Disease

Keywords

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Delirium Dementia Amnestic Cognitive Disorders Mental Disorders Nervous System Diseases Central Nervous System Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dimebon

Group Type EXPERIMENTAL

Dimebon tablet for oral administration

Intervention Type DRUG

10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Interventions

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Dimebon tablet for oral administration

10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon study

Exclusion Criteria

* Any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medivation, Inc.

INDUSTRY

Sponsor Role collaborator

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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Pfizer Investigational Site

Costa Mesa, California, United States

Site Status

Pfizer Investigational Site

Encino, California, United States

Site Status

Pfizer Investigational Site

Los Alamitos, California, United States

Site Status

Pfizer Investigational Site

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

Delray Beach, Florida, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1451030&StudyName=An%20Extension%20To%20The%20B1451006%20Protocol%20To%20Evaluate%20The%20Safety%20and%20Efficacy%20of%20Dimebon%20In%20Subjects%20With%20Moderate-to-Severe%20Alzheimer%27s%20D

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1451030

Identifier Type: -

Identifier Source: org_study_id