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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT02020356
Eligibility Criteria:
Inclusion Criteria:
* Subjects of either sex aged 65 years and over, living in an institution for the dependent elderly for at least 3 months
* Subjects with Alzheimer-type dementia (DSM-IV and National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria)or related symptoms
* If treated, Treated for at least 6 months with a stable dose of cholinesterase inhibitor or memantine
* Mini-Mental State Examination (MMSE) score between 5 and 20
* Patients with disruptive behaviour (at least one disruptive item on the NPI: oppositional behaviour/aggressiveness/agitation, aberrant motor behaviour, with a severity score grater than or equal to 4) and treated with at least one neuroleptic whose dose which could not be decreased because of persistence of the behavioural problems for at least 15 days.
Exclusion Criteria:
* Decompensated physical disease
* Inability to give informed consent
* Lack of health insurance coverage
* Non-corrected hearing impairment
* treatment ongoing with two or more neuroleptics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
100 Years
Study:
NCT02020356
Study Brief:
Protocol Section:
NCT02020356