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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: September 24, 2016
Last verified: September 2016
August 6, 2009
September 24, 2016
October 2009
August 2010   (Final data collection date for primary outcome measure)
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 26 weeks post baseline ]
    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 ]
    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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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
  • Mini-Mental State Examination (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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   United Kingdom
 
 
NCT00954590
DIM19
Yes
Not Provided
Not Provided
Not Provided
Medivation, Inc.
Medivation, Inc.
Pfizer
Not Provided
Medivation, Inc.
September 2016

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