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← Trials/Trial dossier/NCT00000171

CompletedPhase 3

Study of Melatonin: Sleep Problems in Alzheimer's Disease

Asset

Melatonin

Listed sites

31

Recruiting sites

-

Enrollment

-

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 0-26•Study partner/caregiver required

Primary endpoint

-

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIA0006
NCT IDNCT00000171

Timeline

Milestones

Study first posted1999-11-01estimated
Last update posted2005-06-24estimated

Assets

Drug assets

Melatonin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.