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
1 other identifier
interventional
63
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2008
CompletedFirst Posted
Study publicly available on registry
December 17, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedSeptember 2, 2011
September 1, 2011
5 months
December 15, 2008
September 1, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Month 1, 2, 4, 6
Secondary Outcomes (1)
ADAS-Cog, CIBIC-plus, MMSE, QoL-AD
Month 1, 2, 4, 6
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (22)
Site Reference ID/Investigator# 16543
Phoenix, Arizona, 85006, United States
Site Reference ID/Investigator# 16528
Sun City, Arizona, 85351, United States
Site Reference ID/Investigator# 16524
Fresno, California, 93720, United States
Site Reference ID/Investigator# 16520
San Diego, California, 92108, United States
Site Reference ID/Investigator# 16521
Santa Monica, California, 90404, United States
Site Reference ID/Investigator# 16533
Hamden, Connecticut, 06518, United States
Site Reference ID/Investigator# 16516
Brooksville, Florida, 34601, United States
Site Reference ID/Investigator# 16510
Deerfield Beach, Florida, 33064, United States
Site Reference ID/Investigator# 16508
Delray Beach, Florida, 33445, United States
Site Reference ID/Investigator# 16515
Miami, Florida, 33180, United States
Site Reference ID/Investigator# 16545
Palm Beach Gardens, Florida, 33418, United States
Site Reference ID/Investigator# 16541
Sunrise, Florida, 33351, United States
Site Reference ID/Investigator# 16542
Tampa, Florida, 33613, United States
Site Reference ID/Investigator# 16529
West Palm Beach, Florida, 33407, United States
Site Reference ID/Investigator# 16526
Indianapolis, Indiana, 46260, United States
Site Reference ID/Investigator# 16527
Eatontown, New Jersey, 07724, United States
Site Reference ID/Investigator# 16523
Ridgewood, New Jersey, 07450, United States
Site Reference ID/Investigator# 16532
New York, New York, 10021, United States
Site Reference ID/Investigator# 16519
Winston-Salem, North Carolina, 27103, United States
Site Reference ID/Investigator# 16525
Centerville, Ohio, 45459, United States
Site Reference ID/Investigator# 16507
Wichita Falls, Texas, 76309, United States
Site Reference ID/Investigator# 16509
Bennington, Vermont, 05201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Lenz
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2008
First Posted
December 17, 2008
Study Start
January 1, 2009
Primary Completion
June 1, 2009
Last Updated
September 2, 2011
Record last verified: 2011-09