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A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease (CONTACT)

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00954590
First received: August 6, 2009
Last updated: August 27, 2012
Last verified: August 2012

August 6, 2009
August 27, 2012
October 2009
August 2010   (final data collection date for primary outcome measure)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 26 weeks post baseline ] [ Designated as safety issue: No ]
    To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)
  • Activities of Daily Living (severe) (ADCS ADLsev) [ Time Frame: 26 weeks post baseline ] [ Designated as safety issue: No ]
    To evaluate the efficacy of dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer's Disease Cooperative Study - Activities of Daily Living (severe) (ADCS ADLsev).
Not Provided
Complete list of historical versions of study NCT00954590 on ClinicalTrials.gov Archive Site
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A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease
CONTACT: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Six-Month Safety and Efficacy Study of Dimebon in Patients With Moderate-to-Severe Alzheimer's Disease

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Moderate to Severe Alzheimer
  • Drug: Dimebon (latrepirdine)
    20 mg orally three times daily
  • Drug: Placebo
    Placebo orally three times daily
  • Experimental: Dimebon (latrepirdine)
    Dimebon, 20 mg orally three times daily
    Intervention: Drug: Dimebon (latrepirdine)
  • Placebo Comparator: Placebo
    Placebo orally three times daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
89
Not Provided
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate-to-Severe Alzheimer's disease
  • MMSE Score between 5 to 14, 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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Chile,   United Kingdom
 
NCT00954590
DIM19
Yes
Medivation, Inc.
Medivation, Inc.
Pfizer
Not Provided
Medivation, Inc.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP