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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT04948450
Eligibility Criteria:
Inclusion criteria:
We aim to enroll participants aged over 60 years old, living in nursing home, who have a diagnosis of dementia (according to DSM 5 criteria), stage mild to moderate (according to Clinical Dementia Rating scale - CDR). Participants receiving pharmacological treatment for dementia must be on a stable dose for at least 3 months prior to the study. Eligible participants must be able to mobilize independently with or without a mobility aid and without physical assistance.
Exclusion criteria are:
1. Acute and malignant diseases (e.g., advanced cancers, end-stage chronic diseases, acute myocardial infarction, stroke)
2. Symptomatic cardiovascular disease, coronary revascularization within 1 year
3. Clinical evidence of schizophrenia, severe depression, psychiatric or bipolar disorder (according to DSM-V TR criteria)
4. Alcoholism or substance dependence (according to DSM-5 criteria), currently, or within the past 2 years
5. Severe loss of vision, hearing, or communicative ability (according to the interRAI Community Health Assessment)
g. Participant or family unwilling to participate in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04948450
Study Brief:
Protocol Section:
NCT04948450