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

NCT ID: NCT00809510

Last Updated: 2011-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ABT-089

Intervention Type DRUG

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

Interventions

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ABT-089

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Lenz

Role: STUDY_DIRECTOR

Abbott

Locations

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Site Reference ID/Investigator# 16543

Phoenix, Arizona, United States

Site Status

Site Reference ID/Investigator# 16528

Sun City, Arizona, United States

Site Status

Site Reference ID/Investigator# 16524

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 16520

San Diego, California, United States

Site Status

Site Reference ID/Investigator# 16521

Santa Monica, California, United States

Site Status

Site Reference ID/Investigator# 16533

Hamden, Connecticut, United States

Site Status

Site Reference ID/Investigator# 16516

Brooksville, Florida, United States

Site Status

Site Reference ID/Investigator# 16510

Deerfield Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 16508

Delray Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 16515

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 16545

Palm Beach Gardens, Florida, United States

Site Status

Site Reference ID/Investigator# 16541

Sunrise, Florida, United States

Site Status

Site Reference ID/Investigator# 16542

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 16529

West Palm Beach, Florida, United States

Site Status

Site Reference ID/Investigator# 16526

Indianapolis, Indiana, United States

Site Status

Site Reference ID/Investigator# 16527

Eatontown, New Jersey, United States

Site Status

Site Reference ID/Investigator# 16523

Ridgewood, New Jersey, United States

Site Status

Site Reference ID/Investigator# 16532

New York, New York, United States

Site Status

Site Reference ID/Investigator# 16519

Winston-Salem, North Carolina, United States

Site Status

Site Reference ID/Investigator# 16525

Centerville, Ohio, United States

Site Status

Site Reference ID/Investigator# 16507

Wichita Falls, Texas, United States

Site Status

Site Reference ID/Investigator# 16509

Bennington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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M10-745

Identifier Type: -

Identifier Source: org_study_id

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