Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04522960
Study Brief:
Protocol Section:
NCT04522960