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Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00555204
Recruitment Status : Terminated
First Posted : November 8, 2007
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABT-089 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2007
Actual Primary Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: ABT-089
5 mg - capsules once daily for 12 weeks

Experimental: B Drug: ABT-089
10 mg - capsules once daily for 12 weeks

Experimental: C Drug: ABT-089
15 mg - capsules once daily for 12 weeks

Experimental: D Drug: ABT-089
20 mg - capsules once daily for 12 weeks

Experimental: E Drug: ABT-089
30 mg - capsules once daily for 12 weeks

Experimental: F Drug: ABT-089
35 mg - capsules once daily for 12 weeks

Placebo Comparator: G Drug: placebo
placebo - capsules once daily for 12 weeks

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ]

Secondary Outcome Measures :
  1. Pharmacokinetics (how the body handles the study drug) [ Time Frame: Baseline to Final Evaluation ]
  2. Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory) [ Time Frame: Baseline to Final Evaluation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555204

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United States, Arizona
Phoenix, Arizona, United States, 85006
Sun City, Arizona, United States, 85351
United States, California
Fresno, California, United States, 93720
San Diego, California, United States, 92108
Santa Ana, California, United States, 92705
Santa Monica, California, United States, 90404
United States, Connecticut
Hamden, Connecticut, United States, 06518
New Haven, Connecticut, United States, 06510
United States, Florida
Brooksville, Florida, United States, 34613
Delray Beach, Florida, United States, 33445
Fort Myers, Florida, United States, 33901
Hallendale, Florida, United States, 33009
Hialeah, Florida, United States, 33016
Largo, Florida, United States, 33770
Miami, Florida, United States, 33180
Palm Beach Gardens, Florida, United States, 33418
Sunrise, Florida, United States, 33351
Tampa, Florida, United States, 33613
West Palm Beach, Florida, United States, 33407
West Palm Beach, Florida, United States, 33409
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Paducah, Kentucky, United States, 42003
United States, Massachusetts
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Grand Rapids, Michigan, United States, 49503
United States, Missouri
St Louis, Missouri, United States, 63141
United States, New Jersey
Long Branch, New Jersey, United States, 07740
Nutley, New Jersey, United States, 07110
Princeton, New Jersey, United States, 08540
Ridgewood, New Jersey, United States, 07450
United States, New York
Albany, New York, United States, 12208
Bronx, New York, United States, 10454
New York, New York, United States, 10021
Staten Island, New York, United States, 10312
United States, North Carolina
Hickory, North Carolina, United States, 28601
Winston-Salem, North Carolina, United States, 27104
United States, Ohio
Centerville, Ohio, United States, 45459
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Norristown, Pennsylvania, United States, 19401
United States, Texas
San Antonio, Texas, United States, 78229
Wichita Falls, Texas, United States, 76309
United States, Vermont
Bennington, Vermont, United States, 05201
Sponsors and Collaborators
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Study Director: Robert Lenz, MD, PhD Abbott
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00555204    
Other Study ID Numbers: M06-876
First Posted: November 8, 2007    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011
Keywords provided by Abbott:
mild to moderate Alzheimer's disease, memory, cognition, dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders