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:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT03778151
Eligibility Criteria:
Inclusion Criteria:
1. The patient and the responsible caregiver have signed the Informed Consent Form.
2. The patient has probable AD, diagnosed according to NINCDS-ADRDA criteria.
3. The patient is a man or woman, aged ≤ 85 years.
4. The patient has a CDR total score of 0.5 or 1 (mild) and MMSE score of 18-26 (inclusive) at Screening.
5. Has at least one identified adult caregiver
6. The patient has been treated with acetylcholinesterase inhibitor (AChEI), i.e., donepezil, galantamine, or rivastigmine, at the time of Screening
* For at least 3 months
* The current dosage regimen must have remained stable for ≥ 8 weeks
* It must be planned that the dosage regimen will remain stable throughout participation in the study
7. The patient is able to comply with the study procedures in the view of the investigator.
Exclusion Criteria:
1. Significant neurodegenerative disorder of the central nervous system other than Alzheimer's disease
2. Significant intracranial focal or vascular pathology seen on brain MRI scan
3. History of seizure (with the exception of febrile seizures in childhood)
4. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM IV-TR) criteria met for any of the following within specified period:
* Major depressive disorder (current)
* Schizophrenia (lifetime)
* Other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders (within the past 5 years)
5. Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MR imaging.
6. Treatment currently or within 3 months before Baseline with any of the following medications:
* Typical and atypical antipsychotics (i.e. Clozapine, Olanzapine)
* Antiepileptics drugs (i.e. Carbamazepine, Primidone, Pregabalin, Gabapentin)
* Memantine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT03778151
Study Brief:
Protocol Section:
NCT03778151