A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00069849
First received: October 1, 2003
Last updated: August 31, 2006
Last verified: August 2006
  Purpose

The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: ABT-089
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • MMSE

Estimated Enrollment: 64
Study Start Date: July 2003
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Current diagnosis of probable Alzheimer's disease.
  • ADAS-cog score of at least 12 and MMSE score of 10 to 26.
  • Non-smoker
  • Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person.
  • Fluent in English.

EXCLUSION CRITERIA:

  • Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks.
  • Has clinically significant or uncontrolled medical condition other than Alzheimer's disease.
  • Nursing home resident.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069849

Locations
United States, California
Fresno, California, United States
San Diego, California, United States
United States, Florida
Orlando, Florida, United States
West Palm Beach, Florida, United States
United States, Kentucky
Florence, Kentucky, United States
United States, Oregon
Portland, Oregon, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Vermont
Bennington, Vermont, United States
Sponsors and Collaborators
Abbott
Investigators
Study Director: Katherine A Tracy, M.D. Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00069849     History of Changes
Other Study ID Numbers: M03-614
Study First Received: October 1, 2003
Last Updated: August 31, 2006
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 September 15, 2014