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

NCT04522960 | Unknown

• 1 other identifier: UZB-NEU-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• CSF and blood melatonin levels in patients with AD dementia, MCI due to AD and healthy volunteers

  Comparison of CSF and blood melatonin levels between patients with MCI and dementia due to AD and healthy volunteers.

  24 hours

• Blood, saliva and urine melatonin correlations

  Correlation between blood melatonin and urinary and salivary melatonin in the AD continuum

  24 hours

• Melatonin influence on cognition

  Correlations between melatonin levels and cognitive performance over a 2 year time frame. This will be assessed by use of neuropsychological testing including MMSE, MoCA, RBANS, VAT, ...

  2 years

• Melatonin influence on epileptiform activity

  Correlations between melatonin levels and (subclinical) epileptiform activity. Over a time frame of 8 weeks patients will undergo neuropsychological testing (with MMSE, MoCA, RBANS, VAT...), LTM-EEG monitoring (during 24 hours), MEG + hdEEG.

  8 weeks

Study Arms (2)

Patients with dementia or mild cognitive impairment due to AD

EXPERIMENTAL

Dementia or MCI due to AD according to NIA-AA research criteria.

Diagnostic Test: MEG+hdEEG+MRI

Healthy volunteers

ACTIVE COMPARATOR

Age-and-gender matched healthy controls.

Diagnostic Test: MEG+hdEEG+MRI

Interventions

MEG+hdEEG+MRI DIAGNOSTIC_TEST

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

Also known as: Lumbar puncture, Long-term EEG monitoring, Blood sampling, Saliva collection, Urine collection, Neuropsychological examination

Healthy volunteers; Patients with dementia or mild cognitive impairment due to AD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dementia due to AD, according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria
• MCI due to AD, according to NIA-AA criteria
• Healthy controls: Age- and gender matched healthy controls

You may not qualify if:

• Patients (AD dementia, MCI)
• Age \< 18 years old
• Pregnancy
• Expected death due to illness within 2 years
• Pacemaker or other ferrromagnetic material that is not MRI compatible
• Other neurodegenerative or cerebrovascular disease
• Pattern compatible with NPH (clinically, imaging)
• Epilepsy
• Multiple sclerosis or other demyelinating disease
• Depression, psychosis or other mental disease
• Use of anti-epileptic drugs
• Alcohol or substance abuse
• Korsakoff syndrome
• Symptomatic liver disease
• Uncontrolled thyroid disorders

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Spinal Puncture; Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Sebastiaan Engelborghs, MD, PHD

CONTACT

02 477 64 10; sebastiaan.engelborghs@uzbrussel.be

Amber Nous, MD

CONTACT

0479477937; amber.nous@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 21, 2020
• Study Start: October 20, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)