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Melatonin for Cognitive Impairment

N/A
Recruiting
Led By Natalie Denburg, Ph.D.
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
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).
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I am between 56 and 85 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Episodic memory
Secondary outcome measures
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%
Headache
3%
Peripheral Neuropathy
3%
Neutropenia
2%
Appetite changes
2%
Air Leak
2%
Dizziness
2%
Chest pain
2%
Cold/Flu Symptoms
1%
Weight loss
1%
Pneumothorax
1%
New Neoplasm - Lung Cancer
1%
dry mouth
1%
Anorexia
1%
Anemia
1%
Pneumonia
1%
Back pain
1%
Erythema
1%
Flatulence
1%
Vertigo
1%
Bonchitis
1%
Pulmonary embolism
1%
Gall bladder attack
1%
GERD
1%
Anxiety
1%
Tinnitus
1%
Depression
1%
Syncope
1%
Acid reflux
1%
Epistaxis
1%
Pruritis
1%
Rash
1%
Prolonged Air Leak
1%
Hyperglycemia
1%
Thrush (mouth)
1%
Hip replacement surgery
1%
Subcutaneous Emphysema
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%
New Neoplasm
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
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current count of participants for this clinical investigation?

"Affirmative, the clinicaltrial.gov page indicates that this medical experiment is presently searching for participants. It was initialised on November 12th 2019 and most recently updated on February 10th 2022. The research seeks 230 individuals from a single location to partake in it."

Answered by AI

Is enrollment limited to individuals over 24 years old for this clinical trial?

"This research trial has outlined that all participants must be aged between 56 and 85. There are 25 trials dedicated to minors, whereas 576 studies focus on those beyond the age of retirement."

Answered by AI

Is this medical experiment currently in the process of enlisting participants?

"According to clinicaltrials.gov, the process of enrolling candidates is underway for this medical trial that was first publicised on November 12th 2019 and recently modified February 10th 2022."

Answered by AI

To whom is this research opportunity available?

"To be enrolled in this trial, geriatric patients aged 56 to 85 must demonstrate healthy ageing processes. The team hopes to recruit a total of 230 individuals for the study."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
University of Iowa Hospitals & Clinics
Recent research and studies
clinicaltrials.govStudy
Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging
Natalie Denburg 2019. "Disease Modifying Potential of 5mg of Melatonin on Cognition and Brain Health in Aging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03954899.
All > Mci > Melatonin
~58 spots leftby Nov 2025
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