Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease
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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 |
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Recruitment Status :
Terminated
First Posted : November 8, 2007
Last Update Posted : August 23, 2011
|
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
- Study Details
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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 |
| 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
MedlinePlus Genetics related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
| 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 :
- Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ]
Secondary Outcome Measures :
- Pharmacokinetics (how the body handles the study drug) [ Time Frame: Baseline to Final Evaluation ]
- 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 |
Criteria
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
Locations
| 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
Abbott
Investigators
| Study Director: | Robert Lenz, MD, PhD | Abbott |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |