Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Natalie Denburg
Study ID
NCT03954899
Status
Recruiting
Apply to this trial

Conditions

  • Cognitive Decline
  • Healthy Aging
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
56 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • melatonin — DIETARY_SUPPLEMENT
    5mg of melatonin-otc 30 minutes before sleep
  • placebo — OTHER
    placebo 30 minutes before sleep

Study Details

The study will examine whether 5mg melatonin (over the counter, OTC) over a 9-month period improves Alzheimer's disease (AD) biomarkers and cognitive function in two groups of individuals: those with mild cognitive impairment (MCI+) and those who are not (MCI-). AD biomarkers will be measured from cerebrospinal fluid (CSF) obtained from lumbar punctures. Cognitive function will be evaluated with routine neuropsychological tests. AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. BUT ARE CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING.

Key Dates

Start date
Nov 12, 2019
Status verified
Feb 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: MCI+ Melatonin 5mg
    MCI+ individuals receiving 5mg of melatonin-OTC for a period of 9 months
  • Placebo Comparator: MCI+ placebo
    MCI+ individuals receiving placebo for a period of 9 months
  • Experimental: MCI- Melatonin 5mg
    MCI- individuals receiving 5mg of melatonin-OTC for a period of 9 months
  • Placebo Comparator: MCI- placebo
    MCI- individuals receiving placebo for a period of 9 months

Primary Outcome Measure

Episodic memory [ Time Frame: Assessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals & ClinicsIowa CityIowa52242
Natalie Denburg, Ph.D.
[email protected]
3193846050
Natalie Denburg, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Iowa City, IA

By research site
University of Iowa Hospitals & Clinics· Iowa City, IA

Related Studies