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A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

NCT ID: NCT00838110

Last Updated: 2018-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-01-31

Brief Summary

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This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.

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Detailed Description

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Conditions

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Alzheimer's Disease

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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Dimebon 20 mg TID (Cohort 1)

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

10 mg TID for week 1 followed by 20 mg TID through Week 26

Placebo TID (Cohort 1)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10 mg TID for week 1 followed by 20 mg TID through Week 26

Dimebon 20 mg TID (Cohort 2)

Group Type EXPERIMENTAL

Dimebon

Intervention Type DRUG

10 mg TID for week 1 followed by 20 mg TID through Week 12

Placebo TID (Cohort 2)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

Interventions

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Dimebon

10 mg TID for week 1 followed by 20 mg TID through Week 26

Intervention Type DRUG

Placebo

10 mg TID for week 1 followed by 20 mg TID through Week 26

Intervention Type DRUG

Dimebon

10 mg TID for week 1 followed by 20 mg TID through Week 12

Intervention Type DRUG

Placebo

20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Alzheimer's Disease.
* MMSE 12-26 inclusive.
* If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
* If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Exclusion Criteria

* Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region \[e.g., thalamus, hippocampus\]).
* Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
* Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
* Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.
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

Mobile, Alabama, United States

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Northport, Alabama, United States

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Little Rock, Arkansas, United States

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Oceanside, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Pueblo, Colorado, United States

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Hockessin, Delaware, United States

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Bradenton, Florida, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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Daytona Beach, Florida, United States

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Destin, Florida, United States

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Fort Myers, Florida, United States

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Fort Walton Beach, Florida, United States

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Fruitland Park, Florida, United States

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Melbourne, Florida, United States

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Naples, Florida, United States

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Ocala, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Plant City, Florida, United States

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Port Charlotte, Florida, United States

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Port Orange, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Burr Ridge, Illinois, United States

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Elk Grove Village, Illinois, United States

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Elkhart, Indiana, United States

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Evansville, Indiana, United States

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Fort Wayne, Indiana, United States

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Greenfield, Indiana, United States

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Prairie Village, Kansas, United States

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Wichita, Kansas, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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West Yarmouth, Massachusetts, United States

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Flowood, Mississippi, United States

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Olive Branch, Mississippi, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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Great Falls, Montana, United States

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Eatontown, New Jersey, United States

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Oakhurst, New Jersey, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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Amherst, New York, United States

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Buffalo, New York, United States

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Buffalo, New York, United States

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Orchard Park, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Beaver, Pennsylvania, United States

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Bridgeville, Pennsylvania, United States

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Grove City, Pennsylvania, United States

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Indiana, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Upper Saint Clair, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Murrells Inlet, South Carolina, United States

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North Charleston, South Carolina, United States

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Orangeburg, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Franklin, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Carrollton, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Grand Prairie, Texas, United States

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Houston, Texas, United States

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Lake Jackson, Texas, United States

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Williamsburg, Virginia, United States

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Kirkland, Washington, United States

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Spokane, Washington, United States

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Charleston, West Virginia, United States

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La Crosse, Wisconsin, United States

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Calgary, Alberta, Canada

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Medicine Hat, Alberta, Canada

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Surrey, British Columbia, Canada

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Victoria, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Bay Roberts, Newfoundland and Labrador, Canada

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Kentville, Nova Scotia, Canada

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Pictou, Nova Scotia, Canada

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Burlington, Ontario, Canada

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Corunna, Ontario, Canada

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London, Ontario, Canada

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Sarnia, Ontario, Canada

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Greenfield Park, Quebec, Canada

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L'Ancienne-Lorette, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Saint-Léonard, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Cayey, PR, Puerto Rico

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Rio Piedras, PR, Puerto Rico

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San Juan, PR, Puerto Rico

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San Juan, PR, Puerto Rico

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Cidra, , Puerto Rico

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Countries

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United States Canada Puerto Rico

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1451027

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

Other Identifiers

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B1451027

Identifier Type: -

Identifier Source: org_study_id

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