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

August 31, 2006 updated by: Abbott
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States
      • San Diego, California, United States
    • Florida
      • Orlando, Florida, United States
      • West Palm Beach, Florida, United States
    • Kentucky
      • Florence, Kentucky, United States
    • Oregon
      • Portland, Oregon, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Bennington, Vermont, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
MMSE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Katherine A Tracy, M.D., Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Registration Dates

First Submitted

October 1, 2003

First Submitted That Met QC Criteria

October 1, 2003

First Posted (Estimate)

October 2, 2003

Study Record Updates

Last Update Posted (Estimate)

September 4, 2006

Last Update Submitted That Met QC Criteria

August 31, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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