Study of Melatonin: Sleep Problems in Alzheimer's Disease

June 23, 2005 updated by: National Institute on Aging (NIA)
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 55 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Study Director: Cliff Singer, M.D., Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 6, 2022

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

October 29, 1999

First Submitted That Met QC Criteria

October 29, 1999

First Posted (Estimate)

November 1, 1999

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0006
  • 3U01AG010483-08S2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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