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
This study has been terminated.
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00809510
First received: December 15, 2008
Last updated: September 1, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: ABT-089 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Abbott:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- ADAS-Cog, CIBIC-plus, MMSE, QoL-AD [ Time Frame: Month 1, 2, 4, 6 ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | January 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: ABT-089
20 mg ABT-089 taken once-daily for 6 months
Other Name: ABT-089
|
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809510
Locations
| United States, Arizona | |
| Site Reference ID/Investigator# 16543 | |
| Phoenix, Arizona, United States, 85006 | |
| Site Reference ID/Investigator# 16528 | |
| Sun City, Arizona, United States, 85351 | |
| United States, California | |
| Site Reference ID/Investigator# 16524 | |
| Fresno, California, United States, 93720 | |
| Site Reference ID/Investigator# 16520 | |
| San Diego, California, United States, 92108 | |
| Site Reference ID/Investigator# 16521 | |
| Santa Monica, California, United States, 90404 | |
| United States, Connecticut | |
| Site Reference ID/Investigator# 16533 | |
| Hamden, Connecticut, United States, 06518 | |
| United States, Florida | |
| Site Reference ID/Investigator# 16516 | |
| Brooksville, Florida, United States, 34601 | |
| Site Reference ID/Investigator# 16510 | |
| Deerfield Beach, Florida, United States, 33064 | |
| Site Reference ID/Investigator# 16508 | |
| Delray Beach, Florida, United States, 33445 | |
| Site Reference ID/Investigator# 16515 | |
| Miami, Florida, United States, 33180 | |
| Site Reference ID/Investigator# 16545 | |
| Palm Beach Gardens, Florida, United States, 33418 | |
| Site Reference ID/Investigator# 16541 | |
| Sunrise, Florida, United States, 33351 | |
| Site Reference ID/Investigator# 16542 | |
| Tampa, Florida, United States, 33613 | |
| Site Reference ID/Investigator# 16529 | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Indiana | |
| Site Reference ID/Investigator# 16526 | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, New Jersey | |
| Site Reference ID/Investigator# 16527 | |
| Eatontown, New Jersey, United States, 07724 | |
| Site Reference ID/Investigator# 16523 | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| Site Reference ID/Investigator# 16532 | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Site Reference ID/Investigator# 16519 | |
| Winston Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 16525 | |
| Centerville, Ohio, United States, 45459 | |
| United States, Texas | |
| Site Reference ID/Investigator# 16507 | |
| Wichita Falls, Texas, United States, 76309 | |
| United States, Vermont | |
| Site Reference ID/Investigator# 16509 | |
| Bennington, Vermont, United States, 05201 | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Robert Lenz | Abbott |
More Information
No publications provided
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00809510 History of Changes |
| Other Study ID Numbers: | M10-745 |
| Study First Received: | December 15, 2008 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013