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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00809510
First received: December 15, 2008
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ADAS-Cog, CIBIC-plus, MMSE, QoL-AD [ Time Frame: Month 1, 2, 4, 6 ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: January 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ABT-089
20 mg ABT-089 taken once-daily for 6 months
Other Name: ABT-089

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00809510

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00809510     History of Changes
Other Study ID Numbers: M10-745
Study First Received: December 15, 2008
Last Updated: September 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 22, 2014