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NCT00000171 · ClinicalTrials.gov registry record · Phase 3
Study of Melatonin: Sleep Problems in Alzheimer's Disease
A Phase 3 study, sponsored by National Institute on Aging (NIA).
- Completed
- Registry status
- Phase 3
- Development phase
NCT00000171 is a Phase 3 study that has completed, run by National Institute on Aging (NIA).
The verdict
NCT00000171, a Phase 3 study, has completed, sponsored by National Institute on Aging (NIA).
- COMPLETED
- Registry status
- Phase 3
- Development phase
Study 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.
Interventions
- DRUG Melatonin
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000171
The ClinicalTrials.gov registry entry for NCT00000171 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute on Aging (NIA), which has 131 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Melatonin is the first listed.
NCT00000171 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000171 about?
NCT00000171 is a clinical study titled "Study of Melatonin: Sleep Problems in Alzheimer's Disease". 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. Alterna...
What is the current status of trial NCT00000171?
This trial is currently completed. It is a Phase 3 study.
What interventions are being tested in trial NCT00000171?
The interventions under investigation include: Melatonin (DRUG).
Who is sponsoring clinical trial NCT00000171?
This trial is sponsored by National Institute on Aging (NIA), which has 131 total clinical trials registered on ClinicalTrials.gov.
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