Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00555204
Last Updated: 2011-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
337 participants
INTERVENTIONAL
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
ABT-089
5 mg - capsules once daily for 12 weeks
B
ABT-089
10 mg - capsules once daily for 12 weeks
C
ABT-089
15 mg - capsules once daily for 12 weeks
D
ABT-089
20 mg - capsules once daily for 12 weeks
E
ABT-089
30 mg - capsules once daily for 12 weeks
F
ABT-089
35 mg - capsules once daily for 12 weeks
G
placebo
placebo - capsules once daily for 12 weeks
Interventions
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ABT-089
10 mg - capsules once daily for 12 weeks
ABT-089
5 mg - capsules once daily for 12 weeks
ABT-089
15 mg - capsules once daily for 12 weeks
ABT-089
20 mg - capsules once daily for 12 weeks
ABT-089
30 mg - capsules once daily for 12 weeks
ABT-089
35 mg - capsules once daily for 12 weeks
placebo
placebo - capsules once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Patient has been receiving a stable dose of an acetylcholinesterase inhibitor
* Patient has a MMSE score between 12 and 26
* Patient has a MHIS score of less than or equal to 4
* Females must be postmenopausal for at least two years or surgically sterile
* Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit
Exclusion Criteria
* Patient has a history of any significant neurologic disease other than Alzheimer's disease
* Patient has any uncontrolled medical illness
* Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence
55 Years
90 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Lenz, MD, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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Phoenix, Arizona, United States
Sun City, Arizona, United States
Fresno, California, United States
San Diego, California, United States
Santa Ana, California, United States
Santa Monica, California, United States
Hamden, Connecticut, United States
New Haven, Connecticut, United States
Brooksville, Florida, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Hallendale, Florida, United States
Hialeah, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Palm Beach Gardens, Florida, United States
Sunrise, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
West Palm Beach, Florida, United States
Indianapolis, Indiana, United States
Paducah, Kentucky, United States
Pittsfield, Massachusetts, United States
Grand Rapids, Michigan, United States
St Louis, Missouri, United States
Long Branch, New Jersey, United States
Nutley, New Jersey, United States
Princeton, New Jersey, United States
Ridgewood, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Staten Island, New York, United States
The Bronx, New York, United States
Hickory, North Carolina, United States
Winston-Salem, North Carolina, United States
Centerville, Ohio, United States
Cleveland, Ohio, United States
Jenkintown, Pennsylvania, United States
Norristown, Pennsylvania, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
Bennington, Vermont, United States
Countries
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References
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Lenz RA, Pritchett YL, Berry SM, Llano DA, Han S, Berry DA, Sadowsky CH, Abi-Saab WM, Saltarelli MD. Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. doi: 10.1097/WAD.0000000000000093.
Other Identifiers
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M06-876
Identifier Type: -
Identifier Source: org_study_id
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