Status:
UNKNOWN
Melatonin in Alzheimer's Disease: Effect on Disease Progression and Epileptiform Activity.
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 volunt...
Detailed Description
Melatonin production gets disrupted in AD, as shown in post-mortem pineal glands and CSF of AD patients. CSF melatonin levels are known to significantly drop in patients with Alzheimer's dementia. It ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Untreated HIV or syphilis
- Clinically significant vitamin B12 deficiency
- Severe systemic medical illness (eg end-stage cardiac disease, …)
- Use of melatonin, agomelatine, or other sleep medications
- Night worker
- REM sleep behavior disorder, OSAS
- Healthy controls
- Age \< 18 years old
- Pregnancy
- Pacemaker or other ferromagnetic material that is not MRI compatible
- Mild cognitive impairment or dementia of any cause
- Epilepsy
- Multiple sclerosis or other demyelinating disease
- Depression, psychosis or other mental disease
- Use of anti-epileptic drugs
- Alcohol or substance abuse
- Symptomatic liver disease
- Uncontrolled thyroid disorders
- Untreated HIV or syphilis
- Clinically significant vitamin B12 deficiency
- Severe systemic medical illness (eg end-stage cardiac disease, …)
- Use of melatonin, agomelatine, or other sleep medications
- Night worker
- REM sleep behavior disorder, OSAS
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04522960
Start Date
October 20 2020
End Date
July 1 2023
Last Update
May 18 2022
Active Locations (1)
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1
Universitair Ziekenhuis Brussel
Brussels, Jette, Belgium, 1090