Study of Melatonin: Sleep Problems in Alzheimer's Disease
2 other identifiers
interventional
N/A
1 country
31
Brief Summary
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.
Trial Health
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31 active sites
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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:
- Patients must meet NINCDS-ADRDA criteria for probable Alzheimer's disease (AD). Patients must have disrupted sleep, documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors.
- A diagnosis of probable AD.
- MMSE score 0-26.
- Hachinski Ischemia Scale score less than or equal to 4.
- A 2-week history of two or more sleep disorder behaviors, occurring at least once weekly, as reported by the caregiver on the Sleep Disorder Inventory.
- CT or MRI since the onset of memory problems showing no more than one lacunar infarct in a non-strategic area and no clinical events suggestive of stroke or other intracranial disease since the CT or MRI.
- Physically acceptable for study as confirmed by medical history and exam, clinical laboratory results, and EKG.
- Actigraph evidence of a mean nocturnal sleep time of less than 7 hours per night (at least 5 nights of complete actigraph data must be collected over a single week.
- Stable home situation with no planned move during the 13-week investigational period.
- Residing with responsible spouse, family member, or professional caregiver who is present during the night and will agree to assume the role of the principal caregiver for the 13-week protocol, including arranging transport for the patient to and from the investigators' clinic, answering questions regarding the patient's condition, and assuming responsibility for medication and actigraph procedures.
- Ability to ingest oral medication and participate in all scheduled evaluations.
- Six grades of education or work history sufficient to exclude mental retardation.
- years of age or older.
- Hamilton Depression Rating Scale score of 15 or less.
- Stable medication (dose and type) for non-excluded concurrent medical conditions for 4 weeks prior to the screening visit.
You may not qualify if:
- Sleep disturbance is acute (within the last 2 weeks).
- Sleep disturbance is associated with an acute illness with delirium.
- Clinically significant movement disorder that would interfere with the actigraph readings.
- Not having a mobile upper extremity to which to attach an actigraph.
- Severe agitation.
- Pain syndrome affecting sleep.
- Unstable medical condition.
- Use of investigational or unapproved medications within 4 weeks of the screening visit.
- Patient unwilling to maintain caffeine abstinence after 2:00 pm for the duration of the protocol.
- Patient unwilling to comply with the maximum limit of two alcoholic drinks per day, and only one alcoholic drink after 6:00 pm for the duration of the protocol.
- Use of melatonin within 2 weeks of screening visit.
- Clinically significant abnormal laboratory findings that have not been approved by the Project Director.
- Residing in a facility without a consistent caregiver present during the night who can function as the primary informant.
- Caregiver deemed too unreliable to supervise the wearing of the actigraph, to maintain the sleep diary, or to bring the patient to the scheduled visits.
- Autoimmune disease, such as rheumatoid arthritis and polymyalgia rheumatica.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
University of Arizona
Tucson, Arizona, 85724-5023, United States
University of California Irvine Institute for Brain Aging and Dementia
Irvine, California, 92697-4285, United States
University of California, San Diego
La Jolla, California, 92037, United States
University of Southern California
Los Angeles, California, 90033-1039, United States
University of California, Los Angeles
Los Angeles, California, 90095-1769, United States
Yale University, Alzheimer's Disease ResearchUnit
New Haven, Connecticut, 06520-8037, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32225, United States
Mount Sinai (Miami)
Miami, Florida, 33140, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, 30329, United States
Augusta VA Medical Center
Augusta, Georgia, 30904, 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, 40536-0230, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic at Rochester
Rochester, Minnesota, 14620, United States
Washington University
St Louis, Missouri, 63110, United States
New York University Medical Center
New York, New York, 10016, United States
Columbia University
New York, New York, 11032, United States
University of Rochester Medical Center
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
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Brown University
Pawtucket, Rhode Island, 02860, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-8646, United States
University of Texas
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98108, United States
Related Publications (2)
Singer C, Tractenberg RE, Kaye J, Schafer K, Gamst A, Grundman M, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, placebo-controlled trial of melatonin for sleep disturbance in Alzheimer's disease. Sleep. 2003 Nov 1;26(7):893-901. doi: 10.1093/sleep/26.7.893.
PMID: 14655926BACKGROUNDMcCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.
PMID: 33189083DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cliff Singer, M.D.
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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