Back to resultsA Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease (CONTACT)
Primary Purpose
Moderate to Severe Alzheimer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dimebon (latrepirdine)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Moderate to Severe Alzheimer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dimebon (latrepirdine)
Placebo
Arm Description
Dimebon, 20 mg orally three times daily
Placebo orally three times daily
Outcomes
Primary Outcome Measures
Neuropsychiatric Inventory (NPI)
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)
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00954590
First Posted
August 6, 2009
Last Updated
September 24, 2016
Sponsor
Medivation, Inc.
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00954590
Brief Title
A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease
Acronym
CONTACT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Alzheimer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dimebon (latrepirdine)
Arm Type
Experimental
Arm Description
Dimebon, 20 mg orally three times daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo orally three times daily
Intervention Type
Drug
Intervention Name(s)
Dimebon (latrepirdine)
Intervention Description
20 mg orally three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally three times daily
Primary Outcome Measure Information:
Title
Neuropsychiatric Inventory (NPI)
Description
To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)
Time Frame
26 weeks post baseline
Title
Activities of Daily Living (severe) (ADCS ADLsev)
Description
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).
Time Frame
26 weeks post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Santiago
Country
Chile
City
Glasgow
State/Province
Scotland
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease
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