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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT04516057
Eligibility Criteria:
Inclusion Criteria:
1. Males or females ≥55 years of age; females must be post-menopausal
2. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included
3. sMMSE ≤24
4. Presence of clinically significant agitation based on the IPA definition
5. If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization
6. Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments, as per investigator judgement.
Exclusion Criteria:
1. Change in psychotropic medications less than 1 week prior to study randomization (e.g., concomitant antidepressants)
2. Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions
3. Current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure), as per investigator assessment
4. Current significant liver disease, as per investigator assessment
5. Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)
6. Participants currently meeting DSM 5 criteria for Major Depressive Episode (MDE)
7. Previous or current abuse of/dependence on marijuana
8. Clinically significant delusions and/or hallucinations (NPI-NH delusion/hallucinations subscore ≥4)
9. Reported recreational use of marijuana or other cannabis products within 3 months prior to study randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT04516057
Study Brief:
Protocol Section:
NCT04516057