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Melatonin in Alzheimer's Disease: Effect on Disease Progression and Epileptiform Activity.

NCT04522960 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-18

No results posted yet for this study

Summary

This is a long-term, prospective, observational study to investigate and compare the levels and rhythm of melatonin in patients with AD dementia, mild cognitive impairment due to AD and healthy volunteers. The investigators would like to validate the use of salivary and urine melatonin measurements as an alternative for blood/CSF melatonin. Furthermore, the investigators would like to assess the effects of melatonin levels on cognition by correlating the levels and changes on cognitive tasks over a two year time frame. The investigators will also investigate whether these effects could be due to its anticonvulsive properties.

Conditions

  • Alzheimer Disease

Interventions

DIAGNOSTIC_TEST

MEG+hdEEG+MRI

We will perform several tests: * Neuropsychological testing to evaluate evolution of cognition during our study. * Lumbar puncture, blood sampling, saliva and urine collection to assess melatonin levels at several timepoints within these biological fluids. * MEG+hdEEG and MRI (to project MEG information) ; LTM-EEG to detect epileptiform activity in patients and healthy controls

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04522960 on ClinicalTrials.gov