Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease
A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
1 other identifier
interventional
337
1 country
42
Brief Summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
42 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
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 7, 2007
CompletedFirst Posted
Study publicly available on registry
November 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedAugust 23, 2011
August 1, 2011
1.6 years
November 7, 2007
August 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability
Baseline to Final Evaluation
Secondary Outcomes (2)
Pharmacokinetics (how the body handles the study drug)
Baseline to Final Evaluation
Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)
Baseline to Final Evaluation
Study Arms (7)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALD
EXPERIMENTALE
EXPERIMENTALF
EXPERIMENTALG
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patient has mild to moderate Alzheimer's disease
- 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
You may not qualify if:
- Patient is living in a nursing home
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (42)
Unknown Facility
Phoenix, Arizona, 85006, United States
Unknown Facility
Sun City, Arizona, 85351, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Santa Ana, California, 92705, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Hamden, Connecticut, 06518, United States
Unknown Facility
New Haven, Connecticut, 06510, United States
Unknown Facility
Brooksville, Florida, 34613, United States
Unknown Facility
Delray Beach, Florida, 33445, United States
Unknown Facility
Fort Myers, Florida, 33901, United States
Unknown Facility
Hallendale, Florida, 33009, United States
Unknown Facility
Hialeah, Florida, 33016, United States
Unknown Facility
Largo, Florida, 33770, United States
Unknown Facility
Miami, Florida, 33180, United States
Unknown Facility
Palm Beach Gardens, Florida, 33418, United States
Unknown Facility
Sunrise, Florida, 33351, United States
Unknown Facility
Tampa, Florida, 33613, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Unknown Facility
West Palm Beach, Florida, 33409, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Paducah, Kentucky, 42003, United States
Unknown Facility
Pittsfield, Massachusetts, 01201, United States
Unknown Facility
Grand Rapids, Michigan, 49503, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Long Branch, New Jersey, 07740, United States
Unknown Facility
Nutley, New Jersey, 07110, United States
Unknown Facility
Princeton, New Jersey, 08540, United States
Unknown Facility
Ridgewood, New Jersey, 07450, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Staten Island, New York, 10312, United States
Unknown Facility
The Bronx, New York, 10454, United States
Unknown Facility
Hickory, North Carolina, 28601, United States
Unknown Facility
Winston-Salem, North Carolina, 27104, United States
Unknown Facility
Centerville, Ohio, 45459, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Jenkintown, Pennsylvania, 19046, United States
Unknown Facility
Norristown, Pennsylvania, 19401, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Wichita Falls, Texas, 76309, United States
Unknown Facility
Bennington, Vermont, 05201, United States
Related Publications (1)
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.
PMID: 25973909DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Lenz, MD, PhD
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2007
First Posted
November 8, 2007
Study Start
November 1, 2007
Primary Completion
June 1, 2009
Last Updated
August 23, 2011
Record last verified: 2011-08