Lead Investigator: Nathalie Germain, Universite Laval
Title of Proposal Research: Melatonin and melatonin receptor agonists for the treatment of sleep disturbances associated with neurocognitive disorders
Vivli Data Request: 9481
Funding Source: Awarded to Nathalie Germain from the Canadian Institutes of Health Research (CIHR). Master’s Award: Canada Graduate Scholarships, 2022-04-07
Potential Conflicts of Interest: None
Summary of the Proposed Research:
We want to collect and look at at various academic and pharmaceutical research studies to see if taking melatonin (a hormone that helps induce sleep) and drugs that mimic melatonin can help adults with cognitive disorders sleep better, and improve psychological symptoms. We will compare these melatonin treatments to placebo (a medication that has no active ingredient), other medications to help induce sleep, and other natural products and supplements to see which ones work best. Another type of medication we think may help is known as a melatonin receptor agonist. Receptors are like locks on the surface of cells designed to open when the right chemical binds to its surface, and agonists are like keys that fit into these locks and open them. These types of medications activate or boost melatonin receptors in the brain, helping to treat sleep problems and sometimes depression.
A neurocognitive disorder is a condition that affects mental processes like memory, thinking, and learning, usually leading to difficulties in daily-living activities, and sometimes dementia. Dementia is not a disease by itself, but instead is a general term for a cluster of symptoms characterized by a decline in mental abilities like thinking, memory and planning. All of the following types of patients are interesting for us to study for our research question, because neurocognitive disorders that may lead to dementia both affect sleep and are worsened by disturbances to sleep.
Types of patients that interest us include adults with Alzheimer’s disease (AD), where memory and thinking decline; mild cognitive impairment (MCI), where a person has noticeable memory or cognitive problems, but not severe enough to interfere significantly with daily life; Parkinson’s disease (PD), affecting movement in such a way that causes stiffness, tremors, a loss of balance and sometimes declines in cognition; Lewy body dementia (LBD), a progressive brain disorder due to abnormal protein deposits in the brain causing issues in thinking, behavior, and movement; Aphasia, which impairs communication including speaking or understanding speech and sometimes reading; Huntington’s disease (HD), a rare genetic disorder with physical and cognitive symptoms; Multiple Sclerosis (MS), a chronic disease that affects the central nervous system, involving cognitive decline; and Creutzfeldt-Jakob disease (CJD), a very rare and fatal brain disorder leading to rapid cognitive decline.
Neurocognitive disorders often disrupt sleep patterns, affecting both patients and their caregivers’ quality of life. Melatonin is believed to be a safe and affordable supplement widely used by adults, and may help improve symptoms of these types of disorders by enhancing sleep. Despite its popularity among patients and some healthcare professionals, there’s limited formal evidence supporting its effectiveness, especially in older populations with these types of disorders.
Using a type of method called a systematic review with meta analysis, our aim is to systematically search for studies from all over the world that might help answer our research question, pool data from different research articles and clinical trials, analyze the data all together in one cohesive analysis, assess the quality of the studies we found, determine the overall impact of melatonin in this population, and offer recommendations for future research improvements.
Requested Studies:
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of 8 Week Treatment of Rozerem 8 mg (QHS) in Sleep Disturbed, Mild to Moderately Severe Alzheimer’s Disease Subjects
Data Contributor: Takeda
Study ID: NCT00325728
Sponsor ID: 01-05-TL-375-061