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Melatonin for Cognitive Impairment

N/A
Recruiting
Led By nazan aksan
Research Sponsored by Nazan Aksan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Need to be able and willing to stop using any prescription or non-prescription sleep aids (e.g. Ambien, Sonata, Lunesta, Belsomra, Rozerem, Halcion, Intermezzo, Doxepin, Melatonin, etc.) for the duration of the study except for study-issued medications
Must not have
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
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).

Summary

This trial will study whether melatonin can help improve Alzheimer's disease symptoms and cognitive function.

Who is the study for?
This trial is for adults aged 56-85 with mild cognitive impairment or healthy aging, who score at least 18 on the MoCA test and have a CDR Sum of boxes <1. Participants must not use sleep aids other than study medications, be willing to undergo two lumbar punctures, and bring a study partner to visits. Exclusions include certain medical conditions like obstructive sleep apnea without CPAP, major psychiatric diseases, neurodegenerative diseases, recent hospitalizations or chemotherapy.
What is being tested?
The trial tests if taking 5mg of melatonin daily for nine months can improve Alzheimer's disease biomarkers and cognitive function in people with mild cognitive impairment (MCI+) compared to those without (MCI-). It involves measuring AD biomarkers from spinal fluid and assessing cognition through neuropsychological tests.
What are the potential side effects?
Melatonin may cause side effects such as drowsiness, headache, dizziness or nausea. However, since it is an over-the-counter supplement widely used for sleep disorders its overall risk profile is considered low.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stop using any sleep aids not provided by the study.
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I can stop using any sleep aids not provided by the study.
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I am between 56 and 85 years old.
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I am between 56 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking specific medications like Fluvoxamine, Nifedipine, blood thinners, anti-seizure drugs, muscle relaxants, or narcotic pain relievers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Episodic memory
Secondary study objectives
Acrophase of rest-activity rhythm
Amplitude (Mesor) of rest-activity rhythm
Overall cognitive function
+3 more

Side effects data

From 2017 Phase 3 trial • 709 Patients • NCT00668707
16%
Fatgiue
11%
Insomnia
10%
Death
9%
Nausea
9%
Dyspnea
8%
Diarrhea
5%
Postoperative Pain
4%
Constipation
4%
Cough
3%
Vomiting
3%
Peripheral Neuropathy
3%
Headache
3%
Neutropenia
2%
Appetite changes
2%
Air Leak
2%
Dizziness
2%
Chest pain
2%
Cold/Flu Symptoms
1%
Flatulence
1%
GERD
1%
Back pain
1%
New Neoplasm
1%
Weight loss
1%
Acid reflux
1%
Gall bladder attack
1%
Anemia
1%
Pulmonary embolism
1%
Vertigo
1%
Pneumonia
1%
Bonchitis
1%
Pneumothorax
1%
Syncope
1%
New Neoplasm - Lung Cancer
1%
Tinnitus
1%
Anorexia
1%
Anxiety
1%
Depression
1%
Subcutaneous Emphysema
1%
dry mouth
1%
Erythema
1%
Epistaxis
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Hip replacement surgery
1%
Atrial fibrillation
1%
Indigestion
1%
Peripheral Edema
1%
C-Difficile
1%
Surgical site infection
1%
Fall
1%
Pain
1%
Radiation pneumonitis
1%
Surgical Site Pain
1%
Dry Cough
1%
Pleural effusion
1%
Hypertension
1%
Tachycardia
1%
Dysphagia
1%
Sinus infection
1%
Myalgia
1%
Hearing loss
1%
Hemoptysis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MCI- Melatonin 5mgExperimental Treatment1 Intervention
MCI- individuals receiving 5mg of melatonin-OTC for a period of 9 months
Group II: MCI+ Melatonin 5mgExperimental Treatment1 Intervention
MCI+ individuals receiving 5mg of melatonin-OTC for a period of 9 months
Group III: MCI+ placeboPlacebo Group1 Intervention
MCI+ individuals receiving placebo for a period of 9 months
Group IV: MCI- placeboPlacebo Group1 Intervention
MCI- individuals receiving placebo for a period of 9 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melatonin
2013
Completed Phase 3
~2260

Find a Location

Who is running the clinical trial?

Nazan AksanLead Sponsor
Natalie DenburgLead Sponsor
nazan aksanPrincipal InvestigatorUniversity of Iowa
Natalie Denburg, Ph.D.Principal InvestigatorUniversity of Iowa

Media Library

Melatonin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03954899 — N/A
Healthy Aging Research Study Groups: MCI+ placebo, MCI+ Melatonin 5mg, MCI- Melatonin 5mg, MCI- placebo
Healthy Aging Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT03954899 — N/A
Melatonin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03954899 — N/A
~32 spots leftby Nov 2025
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