Alzheimers disease
Conditions
Interventions
This is a randomized, controlled, two-arm, open-label (non-blind) clinical trial with parallel groups. The study will last three months and will be conducted with 124 participants with a confirmed cli
Sponsors
Faculdade de Medicina de Jundiaí
Apoio a Pesquisa e Pacientes de Cannabis Medicinal - APEPI
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Be a patient at the Geriatric Outpatient Clinic of the Jundiaí Medical School; have a confirmed clinical diagnosis of moderate Alzheimer's disease; be aged 60 or over; be able to administer Cannabis sativa extract orally; both males and females will be accepted; the potential inability of participants to give their consent independently will be respected, with free and informed consent required through a legal guardian, as determined by National Health Council (CNS) Resolution No. 466 of 2012
Exclusion criteria
Exclusion criteria: Have a history of significant adverse reactions to cannabidiol (CBD) and tetrahydrocannabinol (THC); have severe cardiovascular disease; have significant liver or kidney disorders; have uncontrolled endocrine disorders; have severe respiratory disorders; have active autoimmune conditions; have other severe neurological or psychiatric disorders; use medications that may interfere with the results, such as antidepressants, antipsychotics, or benzodiazepines; have previously used Cannabis sativa products containing cannabidiol (CBD) and tetrahydrocannabinol (THC) in the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced score on the Cohen-Mansfield Agitation Inventory (CMAI) after 3 months of treatment with cannabis extract (CBD:THC balanced) compared to the control group receiving standard treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in cognitive performance assessed by the Mini-Addenbrooke’s Cognitive Examination (M-ACE), reduction in other behavioral symptoms assessed by the Neuropsychiatric Inventory (NPI), improvement in functional capacity assessed by Pfeffer’s Functional Activities Questionnaire (FAQ) and the Functional Assessment Staging Test (FAST), and safety/tolerability assessment through adverse effects | — |
Countries
Brazil
Contacts
Public ContactTereza Raquel Viana
Faculdade de Medicina de Jundiaí
Outcome results
None listed