Cannabidiol's Role in Dementia Management
NCT Number: NCT06514066
Acronym: MyC4D
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Dementia, Vascular|Dementia, Mixed
Interventions: DRUG: Cannabidiol Oil
Sponsor: Hospital Pengajar Universiti Putra Malaysia
Collaborators: UPM Consultancy & Services Sdn. Bhd.|Pure Life Collective Pte Ltd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 486
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-10-01
Locations: Hospital Sultan Abdul Aziz Shah, Serdang, Selangor, 43400, Malaysia

Summary:
This trial investigates the therapeutic benefits of cannabidiol (CBD) for Dementia patients in Malaysia. As dementia becomes increasingly prevalent worldwide, there's a pressing demand for impactful remedies. This research will delve into CBD's influence on cognitive functions, daily activities, mental health, and overall life quality of dementia sufferers. Utilizing a range of established assessment instruments, including the ADAS-COG subscale for cognitive effects, the NPI score for psychological well-being, and the QOLAD questionnaire for life quality, we aim to discern CBD's potential in ameliorating the conditions of those with dementia. This study's results could shape novel treatment methods and improved care for dementia patients, benefiting not just Malaysia but the world at large.

Primary Outcome Measures: Cognitive Function: The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-COG), To evaluate cognitive functions using the Alzheimer's Disease Assessment Scale-Cognitive subscale. The ADAS-COG consists of 11 tasks: Word Recall Task, Naming Objects and Fingers, Following Commands, Constructional Praxis, Ideational Praxis, Orientation, Word Recognition Task, Remembering Test Directions, Spoken Language, Comprehension, and Word-Finding Difficulty ., 6 months|Psychological well-being/ assesses psycho-behavioral symptomatology (the Neuropsychiatric Inventory NPI scoring system), To measure psychological well-being. The NPI evaluates neuropsychiatric symptoms through domains including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, apathy, and aberrant motor activity, each with 7-8 specific sub-questions assessing severity and frequency., 6 months|Sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction, evaluated using the Pittsburgh Sleep Quality Index (PSQI), To evaluate sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction. The PSQI consists of 19 individual items, which are combined to form seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored on a 0-3 scale, and the sum of these scores yields one global score., 6 months|Overall quality of life (QOL-AD Questionnaire), To gauge overall quality of life. QOL-AD is a 15-question tool used for assessing the quality of life in patients diagnosed with dementia., 6 months