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RecruitingPhase NA

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

Natalie Denburg

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

Nih1R01AG062673-01
Org study ID201903824
NCT IDNCT03954899

Timeline

Milestones

Study first posted2019-05-17actual
Study start2019-11-12actual
Last update posted2025-03-04actual
Primary completion2025-11estimated (month precision)
Study completion2025-11estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age56 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

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
Fluid / digital biomarkers
2
Behavior / neuropsychiatric
1
Amyloid biomarkers
1
Tau biomarkers
1

Global cognition

2 endpoints
Primary/protocol endpoint

Episodic memory

Time frame:Assessed at pre-treatment (week-8), and two post-treatment occasions: week-16 and week-44.

categorical status, descriptive

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Sleep 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 endpoint
Secondary/protocol endpoint

p-tau/Aβ42 ratio

Time frame:Assessed at pre-treatment (week-8) and one post-treatment occasion (week-44)

ratio, descriptive

Tau biomarkers

1 endpoint
Secondary/protocol endpoint

t-tau

Time frame:Assessed at pre-treatment (week-8) and one post-treatment occasion (week-44)

descriptive

Fluid / digital biomarkers

2 endpoints
Secondary/protocol endpoint

Amplitude (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

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.