Clinical trial: Melatonin in Alzheimer's Disease: Effect on Disease Progression and Epileptiform Activity. (NCT04522960)

Eligibility criteria:
Inclusion Criteria:

          1. Dementia due to AD, according to National Institute on Aging-Alzheimer's Association
             (NIA-AA) criteria

          2. MCI due to AD, according to NIA-AA criteria

          3. Healthy controls: Age- and gender matched healthy controls

        Exclusion Criteria:

        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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? 1