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 is enrolling participants by invitation only.

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00809510

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

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 ]

Estimated Enrollment:	250
Study Start Date:	January 2009
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ABT-089 20 mg ABT-089 taken once-daily for 6 months

Eligibility

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809510

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Daniel Llano, MD, PhD

Abbott

More Information

Responsible Party:	Abbott ( Daniel Llano, MD, PhD )
Study ID Numbers:	M10-745
Study First Received:	December 15, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00809510
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 14, 2009