Agitation in Alzheimer's Disease

NCT ID: NCT00000179

Last Updated: 2005-06-24

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

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Trazodone

Intervention Type DRUG

Haloperidol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Memory problem consistent with a probable diagnosis of Alzheimer's disease (AD)
* Agitation symptoms for at least the past 2 weeks
* Patient has caregiver who can participate
* Patient lives in the same household as the caregiver
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Leon Thal, MD.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Southern Illinois University

Springfield, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

New York University Medical Center

New York, New York, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Teri L, Logsdon RG, Peskind E, Raskind M, Weiner MF, Tractenberg RE, Foster NL, Schneider LS, Sano M, Whitehouse P, Tariot P, Mellow AM, Auchus AP, Grundman M, Thomas RG, Schafer K, Thal LJ; Alzheimer's Disease Cooperative Study. Treatment of agitation in AD: a randomized, placebo-controlled clinical trial. Neurology. 2000 Nov 14;55(9):1271-8. doi: 10.1212/wnl.55.9.1271.

Reference Type RESULT
PMID: 11087767 (View on PubMed)

Related Links

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http://www.alzheimers.org/

The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA)

Other Identifiers

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3U01AG010483-08S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0003

Identifier Type: -

Identifier Source: org_study_id