A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study
September 1, 2011 updated by: Abbott
The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease.
Study Overview
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85006
- Site Reference ID/Investigator# 16543
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Sun City, Arizona, United States, 85351
- Site Reference ID/Investigator# 16528
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California
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Fresno, California, United States, 93720
- Site Reference ID/Investigator# 16524
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San Diego, California, United States, 92108
- Site Reference ID/Investigator# 16520
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Santa Monica, California, United States, 90404
- Site Reference ID/Investigator# 16521
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Connecticut
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Hamden, Connecticut, United States, 06518
- Site Reference ID/Investigator# 16533
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Florida
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Brooksville, Florida, United States, 34601
- Site Reference ID/Investigator# 16516
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Deerfield Beach, Florida, United States, 33064
- Site Reference ID/Investigator# 16510
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Delray Beach, Florida, United States, 33445
- Site Reference ID/Investigator# 16508
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Miami, Florida, United States, 33180
- Site Reference ID/Investigator# 16515
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Palm Beach Gardens, Florida, United States, 33418
- Site Reference ID/Investigator# 16545
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Sunrise, Florida, United States, 33351
- Site Reference ID/Investigator# 16541
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Tampa, Florida, United States, 33613
- Site Reference ID/Investigator# 16542
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West Palm Beach, Florida, United States, 33407
- Site Reference ID/Investigator# 16529
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Indiana
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Indianapolis, Indiana, United States, 46260
- Site Reference ID/Investigator# 16526
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New Jersey
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Eatontown, New Jersey, United States, 07724
- Site Reference ID/Investigator# 16527
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Ridgewood, New Jersey, United States, 07450
- Site Reference ID/Investigator# 16523
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New York
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New York, New York, United States, 10021
- Site Reference ID/Investigator# 16532
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North Carolina
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Winston Salem, North Carolina, United States, 27103
- Site Reference ID/Investigator# 16519
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Ohio
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Centerville, Ohio, United States, 45459
- Site Reference ID/Investigator# 16525
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Texas
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Wichita Falls, Texas, United States, 76309
- Site Reference ID/Investigator# 16507
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Vermont
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Bennington, Vermont, United States, 05201
- Site Reference ID/Investigator# 16509
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject was randomized into Study M06-876 and completed the study.
- The subject must remain on the same dose of AChEI that was used during the M06-876 study.
- The subject is in general good health, as judged by the investigator
Exclusion Criteria:
- The subject is currently, or plans to participate in another experimental study during the course of this trial.
- The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
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20 mg ABT-089 taken once-daily for 6 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time Frame: Month 1, 2, 4, 6
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Month 1, 2, 4, 6
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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ADAS-Cog, CIBIC-plus, MMSE, QoL-AD
Time Frame: Month 1, 2, 4, 6
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Month 1, 2, 4, 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert Lenz, Abbott
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
December 15, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
September 2, 2011
Last Update Submitted That Met QC Criteria
September 1, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10-745
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.