None listed
Conditions
Brief summary
Melatonin has multiple therapeutic benefits. It has anti-oxidant and anti-hypertensive properties, it synchronises the circadian system and also promotes sleep. These are all pathways that could be targeted to slow cognitive decline. Previous randomised controlled studies have all targeted patients with developed dementia/AD in whom the cognitive decline may be too far advanced to modify clinical trajectory. We therefore propose using Melatonin in participants with Mild Cognitive Impairment (the prodromal phase of dementia) who report reduced sleep quality to target modifiable risk factors in this population at risk of for future cognitive decline. The study participants will be 40 older adults (aged 60-80 years) with multi-domain Mild Cognitive Impairment (non-amnestic or amnestic) with subjective sleep disturbance. Participants will be randomised to either daily melatonin or placebo, but both the participants and the experimenters will be blind to which treatment they are on. Primary outcomes include feasibility, acceptability and adherence. Secondary outcomes include the effect of melatonin on brain oxidative stress and sleep disturbance while neurocognition, memory, glucose, mood, blood pressure and other inflammatory biomarkers will also be measured.
Interventions
A three-month randomised controlled, double-blind, parallel group trial in participants with mild cognitive impairment. Participants will be randomly allocated to Melatonin (25mg) or placebo capsules nightly for 3 months. Participants will fill out a compliance sheet where they are required to tick a box every day to show they remembered to take the medication. Further, the amount of capsules returned will be counted.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Between 60-80 years of age. 2. Diagnosis of multi-domain MCI 3.Stability of at least four weeks on permitted medications. 4. Fluent in English
Exclusion criteria
1. Suspected dementia seen by less than or equal to 18 on MoCA Blind 2. History of cerebrovascular events (e.g. stroke, TIA) associated with persisting cognitive changes 3. Shift-work or trans meridian travel within 14 days of assessment 4. Neurological disorders (e.g. Parkinson’s Disease, Epilepsy, Multiple Sclerosis) 5. Head trauma with associated loss of consciousness > 30 mins 6. Current psychiatric disorder including; Bipolar Disorder (I and II) and schizophrenia. 7. Currently regularly taking benzodiazepines, sedatives and hypnotics 8. Current substance abuse or dependence (alcohol and/or other illicit substances) 9. Any significant systematic illness or medical condition that may hinder compliance with protocol 10. Contraindication to MRI scanning such as pace devices, coronary or peripheral artery stents, cochlear implants and renal insufficiency 11. Current major depressive episode (not excluded if receiving treatment using anti-depressants for maintenance of depression or subthreshold depression unless a medication listed in 12.) 12. Currently taking medications such as beta blockers, MAO inhibitors, macrolides, and melatonergics.
Outcome results
None listed