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Completed Phase 3 Interventional

Study of Melatonin: Sleep Problems in Alzheimer's Disease

ClinicalTrials.gov ID: NCT00000171

Public ClinicalTrials.gov record NCT00000171. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 7, 2026, 6:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimer's disease (AD). Frequent nocturnal awakening is a common behavioral symptom of AD. Nighttime wandering and agitated behavior may result in injuries and sleep disruption for caregivers. Alternatives are sorely needed to the currently available sleep medications that have marginal efficacy and serious side effects. Melatonin is a naturally occurring hormone secreted by the pineal gland. It has soporific effects with oral administration and is well tolerated. It enhances sleep in normal older people. Melatonin also may help sleep disturbances associated with AD; however, this remains to be proven.

Study identification

NCT ID
NCT00000171
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
55 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Jun 24, 2005

United States locations

U.S. sites
31
U.S. states
20
U.S. cities
29
Facility City State ZIP Site status
University of Arizona Tucson Arizona 85724-5023 —
University of California Irvine Institute for Brain Aging and Dementia Irvine California 92697-4285 —
University of California, San Diego La Jolla California 92037 —
University of Southern California Los Angeles California 90033-1039 —
University of California, Los Angeles Los Angeles California 90095-1769 —
Yale University, Alzheimer's Disease ResearchUnit New Haven Connecticut 06520-8037 —
Mayo Clinic Jacksonville Jacksonville Florida 32225 —
Mount Sinai (Miami) Miami Florida 33140 —
University of South Florida Tampa Florida — —
Emory University Atlanta Georgia 30329 —
Augusta VA Medical Center Augusta Georgia 30904 —
Southern Illinois University Springfield Illinois 62702 —
University of Kansas Medical Center Kansas City Kansas 66160 —
University of Kentucky Lexington Kentucky 40536-0230 —
Johns Hopkins University Baltimore Maryland 21224 —
University of Michigan Ann Arbor Michigan 48109 —
University of Minnesota Minneapolis Minnesota 55455 —
Mayo Clinic at Rochester Rochester Minnesota 14620 —
Washington University St Louis Missouri 63110 —
New York University Medical Center New York New York 10016 —
Columbia University New York New York 11032 —
University of Rochester Medical Center Rochester New York 14620 —
University Hospitals of Cleveland Cleveland Ohio 44120 —
Oregon Health Sciences University Portland Oregon 97201-3098 —
University of Pennsylvania Philadelphia Pennsylvania 19104-4283 —
University of Pittsburgh Pittsburgh Pennsylvania 15213 —
Brown University Pawtucket Rhode Island 02860 —
Vanderbilt University Medical Center Nashville Tennessee 37212-8646 —
University of Texas Dallas Texas 75235 —
Baylor College of Medicine Houston Texas 77030 —
University of Washington Seattle Washington 98108 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00000171, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 24, 2005 · Synced Oct 7, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00000171 live on ClinicalTrials.gov.

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