Melatonin Supplementation in Mild Cognitive Impairment.

Phase 2

Completed

• Conditions: Mild Cognitive Impairment; Neurological - Dementias; Neurological - Other neurological disorders

• Registration Number: ACTRN12619000876190
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-19
• Study Completion: 2022-04-14
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of people who meet inclusion and exclusion criteria and could potentially joint the study,<br><br>[After all participants have been recruited.];The amount of people who agree to be randomised (and take part in the trial).[After all participants have been recruited. ];The amount of people who correctly adhere to the study medication as instructed using both patient medication diary and capsule counts. [After all participants have concluded the study.]