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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02168920
Eligibility Criteria:
Inclusion Criteria:
* Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).
* Patients who satisfy both of the following diagnostic criteria:
* Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5)
* Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
* Hospitalized patients or care facility patients
* Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22
Exclusion Criteria:
* Patients with complications of dementia or memory impairment other than Alzheimer's type dementia
* Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher
* Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances
* Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke
* Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV
* Patients who require drug therapy for arrhythmia or ischemic heart disease
* Body weight of less than 30 kg
* Patients with a high risk of suicide
* Patients with a complication or history of seizure disorder
* Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis
* Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
89 Years
Study:
NCT02168920
Study Brief:
Protocol Section:
NCT02168920