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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT05432206
Eligibility Criteria:
Inclusion Criteria:
* Patients with severe dementia from different origins (Alzheimer's disease, vascular, mixed)
* Clinical Dementia Rating ≥3
* Persisting behavior problems (Neuropsychiatric Inventory \[NPI\] score \> 10) notwithstanding optimal conventional treatment
* SARS-CoV-2 recovered for two weeks, or SARS-CoV-2 fully vaccinated
* Consent obtained from the representative in the medical field according to art 378 Swiss Civil Code (SCC)
Exclusion Criteria:
* Severe organ deficiency such as cardiac, pulmonary, hepatic, renal insufficiency, or unstable heart rhythm
* Symptomatic orthostatic hypotension
* Major changes or instability of psychotropic medication in the week preceding the study enrolment
* Having taken THC and/or CBD in the 7 days before enrolment
* Hemoglobin \< 10 g/dl
* Severe kidney failure defined by cockcroft calculation \<30 ml/mn
* Alanine aminotransferase and aspartate aminotransferase \> 3x upper limit of normal
* Any other medical conditions that would prevent participation in the whole study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT05432206
Study Brief:
Protocol Section:
NCT05432206