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

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85006 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer 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

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

- 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.

NCT00912288
Pfizer
Terminated
A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease

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A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 26-Week Trial To Evaluate The Efficacy And Safety Of Dimebon In Patients With Moderate-To-Severe Alzheimer's Disease
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer Disease
  • Drug: Dimebon 20 mg po TID
    Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks
    Other Names:
    • PF-01913539
    • Latrepirdine Dihydrochloride
  • Drug: Placebo po TID
    Placebo (matched to Dimebon) po for 26 weeks
  • Experimental: Dimebon
    Intervention: Drug: Dimebon 20 mg po TID
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo po TID
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
86
August 2010
August 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Hungary,   Portugal,   Slovakia,   Spain,   Turkey,   United States
 
 
NCT00912288
B1451006
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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