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Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
Evaluating the Disease Modifying Potential of a Sleep Intervention on Alzheimer's Disease (AD) Biomarkers
Lead sponsor
Asset
Melatonin
Listed sites
1
Recruiting sites
1
Enrollment
230
estimated
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criterion
•CDR-SB ≤1
Primary endpoint
•Episodic memory
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. between ages of 56-85 years
2. all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);
3. all participants must have a clinical dementia rating (CDR) Sum of boxes <1;
4. need to be willing to undergo CSF LP on two occasions over the course of their participation,
5. need to be able and willing to stop using any prescription or non-prescription sleep aids (e.g.(e.g. Ambien, Sonata, Lunesta, Belsomra, Rozerem, Halcion, Intermezzo, Doxepin, Melatonin, etc.) for the duration of the study except for study-issued medications
6. BMI < 35 at the time of enrollment
7. willing to bring a study partner (spouse, child or friend) who knows them well to each of the four visits
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
Exclusion criteria
1. Individuals with any of the following conditions/ diseases will be excluded:
Obstructive sleep apnea (OSA) without CPAP use, chronic obstructive pulmonary disease, emphysema, major psychiatric disease (bipolar, schizophrenia), history of alcohol/drug abuse, neurodegenerative disease diagnosis (e.g. Parkinson's, Lewy body, ALS, MS), prior history of stroke or traumatic brain injury, have undergone chemotherapy in the past 2 years, have been hospitalized for injury/surgery in the past three-months.
2. CDR>=1, clinically significant depression/anxiety (GDS>=9; GAI>=9 ),
3. Participants who are on any of the following medications will be excluded: Fluvoxamine (Luvox)/ Fluoxetine (Prozac), Nifedipine (a blood pressure medication), all anti-coagulants (e.g. Warfarin, Coumadin, Heparin, , Lovenox, Xarelto, Pradaxa, etc.), anti-seizure drugs (e.g. Acetazolamide, Carbamazepine, Clobazam, Clonazepam, Gabapentin, etc.), muscle relaxants (e.g.Baclofen, Valium/ diazepam, Flexeril, etc.), or narcotic pain relievers (e.g.Codeine, Tramadol, Hydrocodone, Demerol, etc).
Endpoints (7)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsEpisodic memory
Time frame:Assessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44.
categorical status, descriptive
Overall cognitive function
Time frame:Assessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44.
descriptive
Behavior / neuropsychiatric
1 endpointSleep Efficiency
Time frame:Daily from actigraphy in the pre-treatment phase which lasts 8 weeks (phase#1) and daily from actigraphy in the post-treatment phase from week-9 to week-16 (phase#2).
descriptive
Amyloid biomarkers
1 endpointp-tau/Aβ42 ratio
Time frame:Assessed at pre-treatment (week-8) and one post-treatment occasion (week-44)
ratio, descriptive
Tau biomarkers
1 endpointt-tau
Time frame:Assessed at pre-treatment (week-8) and one post-treatment occasion (week-44)
descriptive
Fluid / digital biomarkers
2 endpointsAmplitude (Mesor) of rest-activity rhythm
Time frame:Daily from actigraphy in the pre-treatment phase which lasts 8 weeks (phase#1) and daily from actigraphy in the post-treatment phase from week-9 to week-16 (phase#2).
descriptive
Acrophase of rest-activity rhythm
Time frame:Daily from actigraphy in the pre-treatment phase which lasts 8 weeks (phase#1) and daily from actigraphy in the post-treatment phase from week-9 to week-16 (phase#2).
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.