Back to resultsA Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-089
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
INCLUSION CRITERIA: Current diagnosis of probable Alzheimer's disease. ADAS-cog score of at least 12 and MMSE score of 10 to 26. Non-smoker Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person. Fluent in English. EXCLUSION CRITERIA: Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks. Has clinically significant or uncontrolled medical condition other than Alzheimer's disease. Nursing home resident.
Sites / Locations
Outcomes
Primary Outcome Measures
MMSE
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00069849
Brief Title
A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease
Official Title
A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Terminated
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ABT-089
Primary Outcome Measure Information:
Title
MMSE
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Current diagnosis of probable Alzheimer's disease.
ADAS-cog score of at least 12 and MMSE score of 10 to 26.
Non-smoker
Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person.
Fluent in English.
EXCLUSION CRITERIA:
Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks.
Has clinically significant or uncontrolled medical condition other than Alzheimer's disease.
Nursing home resident.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine A Tracy, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Fresno
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Florence
State/Province
Kentucky
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Bennington
State/Province
Vermont
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease
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