MedDataX Logo

A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease

NCT ID: NCT00912288

Last Updated: 2012-10-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-08-31

Brief Summary

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

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Detailed Description

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

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

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

Alzheimer Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alzheimer disease moderate-to-severe memantine safety and efficacy

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.

Dimebon

Group Type EXPERIMENTAL

Dimebon 20 mg po TID

Intervention Type DRUG

Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo po TID

Intervention Type DRUG

Placebo (matched to Dimebon) po for 26 weeks

Interventions

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

Dimebon 20 mg po TID

Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks

Intervention Type DRUG

Placebo po TID

Placebo (matched to Dimebon) po for 26 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PF-01913539 Latrepirdine Dihydrochloride

Eligibility Criteria

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

Inclusion Criteria

* Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.
* Have a Mini-Mental State Exam between 5 and 14 inclusive.
* Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.
* Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.

Exclusion Criteria

* Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.
* Dementia other than Alzheimers disease.
* Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.
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.

Medivation, Inc.

INDUSTRY

Sponsor Role collaborator

Pfizer

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

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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

Pfizer Investigational Site

Phoenix, Arizona, United States

Site Status

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

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

Denver, Colorado, United States

Site Status

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Pfizer Investigational Site

Brooksville, Florida, United States

Site Status

Pfizer Investigational Site

Delray Beach, Florida, United States

Site Status

Pfizer Investigational Site

West Palm Beach, Florida, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Lexington, Kentucky, United States

Site Status

Pfizer Investigational Site

Pittsfield, Massachusetts, United States

Site Status

Pfizer Investigational Site

Princeton, New Jersey, United States

Site Status

Pfizer Investigational Site

Rochester, New York, United States

Site Status

Pfizer Investigational Site

Syracuse, New York, United States

Site Status

Pfizer Investigational Site

Norristown, Pennsylvania, United States

Site Status

Pfizer Investigational Site

East Providence, Rhode Island, United States

Site Status

Pfizer Investigational Site

Cordova, Tennessee, United States

Site Status

Pfizer Investigational Site

Middleton, Wisconsin, United States

Site Status

Pfizer Investigational Site

Winnipeg, Manitoba, Canada

Site Status

Pfizer Investigational Site

Montreal, Quebec, Canada

Site Status

Pfizer Investigational Site

Québec, Quebec, Canada

Site Status

Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Bochum, , Germany

Site Status

Pfizer Investigational Site

Günzburg, , Germany

Site Status

Pfizer Investigational Site

Leipzig, , Germany

Site Status

Pfizer Investigational Site

Mainz, , Germany

Site Status

Pfizer Investigational Site

Mittweida, , Germany

Site Status

Pfizer Investigational Site

Budapest, , Hungary

Site Status

Pfizer Investigational Site

Gyula, , Hungary

Site Status

Pfizer Investigational Site

Székesfehérvár, , Hungary

Site Status

Pfizer Investigational Site

Amadora, , Portugal

Site Status

Pfizer Investigational Site

Coimbra, , Portugal

Site Status

Pfizer Investigational Site

Bratislava, , Slovakia

Site Status

Pfizer Investigational Site

Michalovce, , Slovakia

Site Status

Pfizer Investigational Site

Rožňava, , Slovakia

Site Status

Pfizer Investigational Site

Žilina, , Slovakia

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Algorta, Getxo, Bilbao, Spain

Site Status

Pfizer Investigational Site

Salt, Girona, Spain

Site Status

Pfizer Investigational Site

Seville, Sevilla, Spain

Site Status

Pfizer Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Kocaeli, , Turkey (Türkiye)

Site Status

Pfizer Investigational Site

Samsun, , Turkey (Türkiye)

Site Status

Countries

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

United States Canada Germany Hungary Portugal Slovakia Spain Turkey (Türkiye)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1451006&StudyName=A%20Phase%203%20Efficacy%20Study%20Of%20Dimebon%20In%20Patients%20With%20Moderate%20To%20Severe%20Alzheimer%27s%20Disease

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

Other Identifiers

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

B1451006

Identifier Type: -

Identifier Source: org_study_id