Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000171
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-29
Brief Title:
Study of Melatonin Sleep Problems in Alzheimers Disease
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is a multicenter clinical trial of melatonin for sleep disturbances associated with Alzheimers 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
Detailed Description:
In Alzheimers 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 25 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 Restactivity 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3U01AG010483-08S2 | NIH | None | httpsreporternihgovquickSearch3U01AG010483-08S2 |