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

This study has been terminated.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00069849

First received: October 1, 2003

Last updated: August 31, 2006

Last verified: August 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

October 1, 2003

Last Updated Date

August 31, 2006

Start Date ^ICMJE

July 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

MMSE

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00069849 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: ABT-089

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00069849

Other Study ID Numbers ^ICMJE

M03-614

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Katherine A Tracy, M.D.

Abbott

Information Provided By

Abbott

Verification Date

August 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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