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

Alzheimer's Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00809510
• Other study ID #: M10-745
• Status: Terminated
• Phase: Phase 2
• First received: December 15, 2008
• Last updated: September 1, 2011
• Start date: January 2009

Study information

• Verified date: September 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-089
20 mg ABT-089 taken once-daily for 6 months

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 16509	Bennington	Vermont
United States	Site Reference ID/Investigator# 16516	Brooksville	Florida
United States	Site Reference ID/Investigator# 16525	Centerville	Ohio
United States	Site Reference ID/Investigator# 16510	Deerfield Beach	Florida
United States	Site Reference ID/Investigator# 16508	Delray Beach	Florida
United States	Site Reference ID/Investigator# 16527	Eatontown	New Jersey
United States	Site Reference ID/Investigator# 16524	Fresno	California
United States	Site Reference ID/Investigator# 16533	Hamden	Connecticut
United States	Site Reference ID/Investigator# 16526	Indianapolis	Indiana
United States	Site Reference ID/Investigator# 16515	Miami	Florida
United States	Site Reference ID/Investigator# 16532	New York	New York
United States	Site Reference ID/Investigator# 16545	Palm Beach Gardens	Florida
United States	Site Reference ID/Investigator# 16543	Phoenix	Arizona
United States	Site Reference ID/Investigator# 16523	Ridgewood	New Jersey
United States	Site Reference ID/Investigator# 16520	San Diego	California
United States	Site Reference ID/Investigator# 16521	Santa Monica	California
United States	Site Reference ID/Investigator# 16528	Sun City	Arizona
United States	Site Reference ID/Investigator# 16541	Sunrise	Florida
United States	Site Reference ID/Investigator# 16542	Tampa	Florida
United States	Site Reference ID/Investigator# 16529	West Palm Beach	Florida
United States	Site Reference ID/Investigator# 16507	Wichita Falls	Texas
United States	Site Reference ID/Investigator# 16519	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)		Month 1, 2, 4, 6	Yes
Secondary	ADAS-Cog, CIBIC-plus, MMSE, QoL-AD		Month 1, 2, 4, 6	No