A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

NCT ID: NCT00069849

Last Updated: 2006-09-04

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Brief Summary

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The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with 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

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ABT-089

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Current diagnosis of probable Alzheimer's disease.
* ADAS-cog score of at least 12 and MMSE score of 10 to 26.
* Non-smoker
* Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person.
* Fluent in English.

Exclusion Criteria

* Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks.
* Has clinically significant or uncontrolled medical condition other than Alzheimer's disease.
* Nursing home resident.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Principal Investigators

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Katherine A Tracy, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

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Fresno, California, United States

Site Status

San Diego, California, United States

Site Status

Orlando, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Florence, Kentucky, United States

Site Status

Portland, Oregon, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Bennington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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M03-614

Identifier Type: -

Identifier Source: org_study_id