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

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment; Cognitive Decline; Healthy Aging

• Registration Number: NCT03954899
• Lead Sponsor: Natalie Denburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-5-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. between ages of 56-85 years<br><br> 2. all participants must score 18 or above on Montreal Cognitive Assessment (MoCA);<br><br> 3. all participants must have a clinical dementia rating (CDR) Sum of boxes <1;<br><br> 4. need to be willing to undergo CSF LP on two occasions over the course of their<br> participation,<br><br> 5. need to be able and willing to stop using any prescription or non-prescription sleep<br> aids (e.g.(e.g. Ambien, Sonata, Lunesta, Belsomra, Rozerem, Halcion, Intermezzo,<br> Doxepin, Melatonin, etc.) for the duration of the study except for study-issued<br> medications<br><br> 6. BMI < 35 at the time of enrollment<br><br> 7. willing to bring a study partner (spouse, child or friend) who knows them well to<br> each of the four visits<br><br>AS OF AUGUST 2024, THE LUMBAR PUNCTURE PROCEDURES FOR THIS CLINICAL TRIAL HAVE BEEN<br>ELIMINATED. THAT IS, PARTICIPANTS ARE NO LONGER RECEIVING A LUMBER PUNCTURE. BUT ARE<br>CONTINUING TO RECEIVE TWO SEPARATE BLOOD DRAWS FOR BIOMARKER TESTING.<br><br>The exclusion criteria are:<br><br> 1. Individuals with any of the following conditions/ diseases will be excluded:<br><br> Obstructive sleep apnea (OSA) without CPAP use, chronic obstructive pulmonary<br> disease, emphysema, major psychiatric disease (bipolar, schizophrenia), history of<br> alcohol/drug abuse, neurodegenerative disease diagnosis (e.g. Parkinson's, Lewy<br> body, ALS, MS), prior history of stroke or traumatic brain injury, have undergone<br> chemotherapy in the past 2 years, have been hospitalized for injury/surgery in the<br> past three-months.<br><br> 2. CDR>=1, clinically significant depression/anxiety (GDS>=9; GAI>=9 ),<br><br> 3. Participants who are on any of the following medications will be excluded:<br> Fluvoxamine (Luvox)/ Fluoxetine (Prozac), Nifedipine (a blood pressure medication),<br> all anti-coagulants (e.g. Warfarin, Coumadin, Heparin, , Lovenox, Xarelto, Pradaxa,<br> etc.), anti-seizure drugs (e.g. Acetazolamide, Carbamazepine, Clobazam, Clonazepam,<br> Gabapentin, etc.), muscle relaxants (e.g.Baclofen, Valium/ diazepam, Flexeril,<br> etc.), or narcotic pain relievers (e.g.Codeine, Tramadol, Hydrocodone, Demerol,<br> etc).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episodic memory

Secondary Outcome Measures

Name	Time	Method
Overall cognitive function;p-tau/Aß42 ratio;t-tau;Sleep Efficiency;Amplitude (Mesor) of rest-activity rhythm;Acrophase of rest-activity rhythm