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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT03507504
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of primary dementia (DSM IV)
* MMSE score ≤ 24
* NPI global score ≥ 32/144
* a caregiver (informal/family member or formal caregiver) who commits her/himself to accompany the patient along the three-year course of the study
* living at home (nursing home residents are excluded).
Exclusion Criteria:
* presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD
* concomitant psychiatric disorders or chronic alcoholism
* concomitant diseases severe enough to reduce life expectancy \< 6 months
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03507504
Study Brief:
Protocol Section:
NCT03507504