Agitation in Alzheimer's Disease
2 other identifiers
interventional
N/A
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 1999
CompletedFirst Posted
Study publicly available on registry
November 1, 1999
CompletedJune 24, 2005
March 1, 2005
October 29, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of California, Los Angeles
Los Angeles, California, 90095, United States
University of California, San Diego
San Diego, California, 92093-0949, United States
University of Miami
Miami, Florida, 33140, United States
University of South Florida
Tampa, Florida, 33162, United States
Emory University
Atlanta, Georgia, 30329, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Massachusetts
Worcester, Massachusetts, 01665, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
New York University Medical Center
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of Rochester
Rochester, New York, 14620, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44120, United States
Oregon Health Sciences University
Portland, Oregon, 97201-3098, United States
Related Publications (1)
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.
PMID: 11087767RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leon Thal, MD.
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
October 29, 1999
First Posted
November 1, 1999
Last Updated
June 24, 2005
Record last verified: 2005-03