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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00000171 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease Dyssomnias |
Drug: Melatonin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
In Alzheimer's disease , sleep disruption is one of the most common behavioral problems, occurring in 45 percent of patients. These nocturnal awakenings and agitation lead to considerable burden for caregivers and frequently lead families to the decision of nursing home placement. The proposed study is a randomized, double blind, parallel group, placebo controlled, clinical trial. Placebo will be compared with two doses of melatonin: a 2.5 mg, slow- release preparation and a 10 mg immediate release preparation. One hundred and fifty community-residing AD patients with disrupted sleep will be recruited. Included subjects will meet NINCDS-ADRDA criteria for probable AD. Prior to study entry, disrupted sleep will be documented by clinical history and by 1 to 2 weeks of recording using wrist activity monitors. The treatment period will last 8 weeks. Rest/activity patterns will be recorded by wrist activity monitors. The primary outcome measure will be the change in nocturnal sleep time from baseline to the end of the treatment phase.
Other outcomes also will be examined, including the time awake after sleep onset, sleep latency, sleep efficiency, daytime agitation, and changes in cognition. The relative effectiveness of high and low dose melatonin will be assessed. Adverse events and side effects will be compared by treatment. This study should provide the data necessary to determine whether melatonin is a safe and effective treatment for disrupted sleep associated with AD.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724-5023 | |
| United States, California | |
| University of California Irvine Institute for Brain Aging and Dementia | |
| Irvine, California, United States, 92697-4285 | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095-1769 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033-1039 | |
| University of California, San Diego | |
| La Jolla, California, United States, 92037 | |
| United States, Connecticut | |
| Yale University, Alzheimer's Disease ResearchUnit | |
| New Haven, Connecticut, United States, 06520-8037 | |
| United States, Florida | |
| Mayo Clinic Jacksonville | |
| Jacksonville, Florida, United States, 32225 | |
| Mount Sinai (Miami) | |
| Miami, Florida, United States, 33140 | |
| University of South Florida | |
| Tampa, Florida, United States | |
| United States, Georgia | |
| Augusta VA Medical Center | |
| Augusta, Georgia, United States, 30904 | |
| Emory University | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Illinois | |
| Southern Illinois University | |
| Springfield, Illinois, United States, 62702 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536-0230 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic at Rochester | |
| Rochester, Minnesota, United States, 14620 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 11032 | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14620 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44120 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Brown University | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37212-8646 | |
| United States, Texas | |
| University of Texas | |
| Dallas, Texas, United States, 75235 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98108 | |
| Study Director: | Cliff Singer, M.D. | Oregon Health and Science University |
More Information
| Study ID Numbers: | IA0006, 3U01AG10483-08S2 |
| Study First Received: | October 29, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000171 History of Changes |
| Health Authority: | United States: Federal Government |
|
Alzheimer's disease Sleep disorders Melatonin |
|
Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Dyssomnias Central Nervous System Diseases Sleep Disorders Central Nervous System Depressants Brain Diseases |
Neurodegenerative Diseases Protective Agents Pharmacologic Actions Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Melatonin Dementia Tauopathies Central Nervous System Agents |