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

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: ABT-089

• Registration Number: NCT00809510
• Lead Sponsor: Abbott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Study Start: 2009-01
• Primary Completion: 2009-06
• Status Verified: 2011-09
• Disposition First Submitted: 2011-09-01
• Disposition First Submitted QC: 2011-09-01
• Last Update Submitted: 2011-09-01
• Disposition First Posted: 2011-09-02
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ABT-089	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
ADAS-Cog, CIBIC-plus, MMSE, QoL-AD	Month 1, 2, 4, 6

Trial Locations

Locations (22)

Site Reference ID/Investigator# 16543; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 16528; 🇺🇸 Sun City, Arizona, United States

Site Reference ID/Investigator# 16524; 🇺🇸 Fresno, California, 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# 16533; 🇺🇸 Hamden, Connecticut, United States

Site Reference ID/Investigator# 16516; 🇺🇸 Brooksville, Florida, 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# 16515; 🇺🇸 Miami, Florida, United States

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