Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

NCT ID: NCT00829374

Last Updated: 2016-09-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1003 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Dimebon, 5 mg orally three times daily

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

5 mg orally three times daily

2

Dimebon, 20 mg orally three times daily

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

20 mg orally three times daily

3

Placebo orally three times daily

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

Placebo orally three times daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dimebon

5 mg orally three times daily

Intervention Type DRUG

Dimebon

20 mg orally three times daily

Intervention Type DRUG

Placebo comparator

Placebo orally three times daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mild-to-moderate Alzheimer's disease (AD)
* Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))
* Mini-Mental State Examination (MMSE) score between 12 and 24, inclusive
* Stable on donepezil for at least 6 months

Exclusion Criteria

* Other causes of dementia
* Major structural brain disease
* Unstable medical condition or significant hepatic or renal disease
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Medivation, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phoenix, Arizona, United States

Site Status

Sun City, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Costa Mesa, California, United States

Site Status

Encino, California, United States

Site Status

Escondido, California, United States

Site Status

Fresno, California, United States

Site Status

Garden Grove, California, United States

Site Status

La Jolla, California, United States

Site Status

Los Alamitos, California, United States

Site Status

Los Angeles, California, United States

Site Status

Martinez, California, United States

Site Status

Newport, California, United States

Site Status

Paramount, California, United States

Site Status

Pasadena, California, United States

Site Status

San Diego, California, United States

Site Status

San Francisco, California, United States

Site Status

Boulder, Colorado, United States

Site Status

Denver, Colorado, United States

Site Status

New Haven, Connecticut, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Deerfield Beach, Florida, United States

Site Status

Delray Beach, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Honolulu, Hawaii, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Lexington, Kentucky, United States

Site Status

Eaton, Maryland, United States

Site Status

Boston, Massachusetts, United States

Site Status

Ann Arbor, Michigan, United States

Site Status

Las Vegas, Nevada, United States

Site Status

Mount Arlington, New Jersey, United States

Site Status

Princeton, New Jersey, United States

Site Status

Albany, New York, United States

Site Status

Cedarhurst, New York, United States

Site Status

New York, New York, United States

Site Status

Rochester, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Beachwood, Ohio, United States

Site Status

Toledo, Ohio, United States

Site Status

Jenkintown, Pennsylvania, United States

Site Status

Norristown, Pennsylvania, United States

Site Status

Providence, Rhode Island, United States

Site Status

Austin, Texas, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Charlottesville, Virginia, United States

Site Status

Seattle, Washington, United States

Site Status

Middleton, Wisconsin, United States

Site Status

Newcastle, New South Wales, Australia

Site Status

Sydney, New South Wales, Australia

Site Status

Brisbane, Queensland, Australia

Site Status

Adelaide, South Australia, Australia

Site Status

Geelong, Victoria, Australia

Site Status

Melbourne, Victoria, Australia

Site Status

Perth, Western Australia, Australia

Site Status

Antwerp, , Belgium

Site Status

Leuven, , Belgium

Site Status

Sint-Truiden, , Belgium

Site Status

Kuppio, , Finland

Site Status

Oulu, , Finland

Site Status

Turku, , Finland

Site Status

Bordeaux, , France

Site Status

Concert, , France

Site Status

Lille, , France

Site Status

Montpellier, , France

Site Status

Nice, , France

Site Status

Toulouse, , France

Site Status

Berlin, , Germany

Site Status

Bochum, , Germany

Site Status

Freiburg im Breisgau, , Germany

Site Status

Hattingen, , Germany

Site Status

Mannheim, , Germany

Site Status

Munich, , Germany

Site Status

Brescia, , Italy

Site Status

Florence, , Italy

Site Status

Genoa, , Italy

Site Status

Perugia, , Italy

Site Status

Rome, , Italy

Site Status

Christchurch, Canterbury, New Zealand

Site Status

Auckland, , New Zealand

Site Status

Malmo, , Sweden

Site Status

Norrköping, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Brentford, Middlesex, United Kingdom

Site Status

Rushden, Northhamptonshire, United Kingdom

Site Status

Glasgow, Scotland, United Kingdom

Site Status

Worthington, West Sussex, United Kingdom

Site Status

Bath, , United Kingdom

Site Status

Blackpool, , United Kingdom

Site Status

Bradford, , United Kingdom

Site Status

Greater Manchester, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Newcastle upon Tyne, , United Kingdom

Site Status

Norfolk, , United Kingdom

Site Status

Oxford, , United Kingdom

Site Status

Southampton, , United Kingdom

Site Status

Swindon, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Belgium Finland France Germany Italy New Zealand Sweden United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DIM18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.