Study of Melatonin: Sleep Problems in Alzheimer's Disease

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00000171
Study type	Interventional
Source	National Institute on Aging (NIA)
Contact
Status	Completed
Phase	Phase 3

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04044495` - Sleep, Rhythms and Risk of Alzheimer's Disease	N/A
Completed	`NCT04079803` - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients	Phase 2
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT04520698` - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease	N/A
Active, not recruiting	`NCT04606420` - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease	N/A
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Terminated	`NCT03672474` - REGEnLIFE RGn530 - Feasibility Pilot	N/A
Completed	`NCT03430648` - Is Tau Protein Linked to Mobility Function?
Recruiting	`NCT04949750` - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease	N/A
Recruiting	`NCT05557409` - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation	Phase 3
Recruiting	`NCT04522739` - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease	Phase 4
Recruiting	`NCT05288842` - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Completed	`NCT06194552` - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07	Phase 1
Completed	`NCT03239561` - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants	Early Phase 1
Completed	`NCT03184467` - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients	Phase 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated	`NCT03487380` - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Recruiting	`NCT05328115` - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease	Phase 1
Completed	`NCT05562583` - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.