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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

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Costa Mesa, California, 92626 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01066546
Pfizer
Terminated
An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease

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Descriptive Information
Brief Title  ICMJE An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease
Official Title  ICMJE An Open-Label Extension To The B1451006 Protocol To Evaluate The Safety And Efficacy Of Dimebon (Latrepirdine, PF-01913539) In Subjects With Moderate-To-Severe Alzheimer's Disease
Brief SummaryThe 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 DescriptionThis 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE Drug: Dimebon tablet for oral administration
10 mg TID for Week 1, followed by 20 mg TID for remainder of study
Study Arms  ICMJE Experimental: Dimebon
Intervention: Drug: Dimebon tablet for oral administration
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 8, 2010)
5
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2010)
576
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion DateJuly 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01066546
Other Study ID Numbers  ICMJE B1451030
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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