A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study

September 1, 2011 updated by: Abbott
The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

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
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Site Reference ID/Investigator# 16543
      • Sun City, Arizona, United States, 85351
        • Site Reference ID/Investigator# 16528
    • California
      • Fresno, California, United States, 93720
        • Site Reference ID/Investigator# 16524
      • San Diego, California, United States, 92108
        • Site Reference ID/Investigator# 16520
      • Santa Monica, California, United States, 90404
        • Site Reference ID/Investigator# 16521
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Site Reference ID/Investigator# 16533
    • Florida
      • Brooksville, Florida, United States, 34601
        • Site Reference ID/Investigator# 16516
      • Deerfield Beach, Florida, United States, 33064
        • Site Reference ID/Investigator# 16510
      • Delray Beach, Florida, United States, 33445
        • Site Reference ID/Investigator# 16508
      • Miami, Florida, United States, 33180
        • Site Reference ID/Investigator# 16515
      • Palm Beach Gardens, Florida, United States, 33418
        • Site Reference ID/Investigator# 16545
      • Sunrise, Florida, United States, 33351
        • Site Reference ID/Investigator# 16541
      • Tampa, Florida, United States, 33613
        • Site Reference ID/Investigator# 16542
      • West Palm Beach, Florida, United States, 33407
        • Site Reference ID/Investigator# 16529
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Site Reference ID/Investigator# 16526
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Site Reference ID/Investigator# 16527
      • Ridgewood, New Jersey, United States, 07450
        • Site Reference ID/Investigator# 16523
    • New York
      • New York, New York, United States, 10021
        • Site Reference ID/Investigator# 16532
    • North Carolina
      • Winston Salem, North Carolina, United States, 27103
        • Site Reference ID/Investigator# 16519
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Site Reference ID/Investigator# 16525
    • Texas
      • Wichita Falls, Texas, United States, 76309
        • Site Reference ID/Investigator# 16507
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Site Reference ID/Investigator# 16509

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

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject was randomized into Study M06-876 and completed the study.
  • The subject must remain on the same dose of AChEI that was used during the M06-876 study.
  • The subject is in general good health, as judged by the investigator

Exclusion Criteria:

  • The subject is currently, or plans to participate in another experimental study during the course of this trial.
  • The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ABT-089
20 mg ABT-089 taken once-daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time Frame: Month 1, 2, 4, 6
Month 1, 2, 4, 6

Secondary Outcome Measures

Outcome Measure
Time Frame
ADAS-Cog, CIBIC-plus, MMSE, QoL-AD
Time Frame: Month 1, 2, 4, 6
Month 1, 2, 4, 6

Collaborators and Investigators

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

Sponsor

Abbott

Investigators

  • Study Director: Robert Lenz, 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

January 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 16, 2008

First Posted (Estimate)

December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

September 1, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-745

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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