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 2TerminatedNCT00809510

Abbott63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer's Disease

Interventions

ABT-089DRUG

20 mg ABT-089 taken once-daily for 6 months

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (22)

Site Reference ID/Investigator# 16543

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

ADAS-Cog, CIBIC-plus, MMSE, QoL-AD

Time frame: Month 1, 2, 4, 6

Data from ClinicalTrials.gov

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