Clinical trial NCT06514066: Cannabidiol's Role in Dementia Management
Official title: Cannabidiol's Role in Dementia Management: Evaluating Cognitive, Quality of Life, and Well-being Outcomes in Malaysia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Dementia, Vascular
Dementia, Mixed
Lead sponsor: Hospital Pengajar Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: UPM Consultancy & Services Sdn. Bhd.
name: Pure Life Collective Pte Ltd
First posted: 2024-07-23
Enrollment: 486
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age: Participants (male and female) must be 50 years of age or older at the time of enrollment. This criterion is necessary to ensure that participants can legally provide informed consent for their participation.
2. Diagnosis: Participants must have a confirmed diagnosis of mild to severe dementia based on DSM-5 and Clinical Dementia Rating (CDR). Diagnosis should be confirmed by either neurologist, psychiatrist or geriatrician that attend the pattients.
3. Stability of Condition: Participants' disease status must be stable at the time of enrollment, as determined by the investigator. For example, seizure frequency for those with epilepsy should be consistent for a specified period (e.g., the past three months) before study entry.
4. Consent: The caregivers of the participants must provide written informed consent to participate in the study. The consent form must be read, understood, and signed by the caregivers before any study-specific procedures are performed.
5. Ability to Comply: Participants' caregivers must be willing and able to comply with all study procedures and requirements needed by the study. The caregivers must ensure that the participants has the ability to ingest oral medication, and they need to complete surveys on behalf of the participants on their phone, record log seizures (if applicable), and bring the patients to attend all necessary study visits.
6. Health Status: Participants must be in a health state, as determined by the investigator that will not put them at undue risk of harm from participating in the study or interfere with the study's ability to achieve its objectives.
7. Additional Criteria for Cancer Patients: Cancer patients must not be on any active chemotherapy and radiation treatment, as determined by the investigator.

The exact specifications of these criteria will be determined in consultation with Malaysian clinical experts and will be clearly defined in the study's protocol. These criteria are intended to ensure the study's results are valid, reliable, and applicable to the target population.

Exclusion Criteria:

1. Cannot fulfil all the requirement as above.
2. Substance Use: Active usage of substances/medications such as cocaine, opiates, benzodiazepines, barbiturates, amphetamines, morphine, methadone, methamphetamines, oxycodone, phencyclidine, tricyclic antidepressants, tetrahydrocannabinol, buprenorphine, methylenedioxymethamphetamine, propoxyphene.
3. Concurrent Treatments: Participants currently participating in another clinical trial or using other experimental treatments for their condition. Participants who have used any medication, dietary supplements (and/or grapefruit juice), or combination of medications and supplements known to alter the metabolism of, or interact with CBD (bupropion, rifampin, barbiturates, phenothiazines, cimetidine, etc.) 14 days prior to and during the duration of the study.
4. Significant Health Risks: Participants with significant cardiovascular, hepatic, renal, respiratory, or psychiatric disease, which, in the investigator's opinion, would place the participant at undue risk or interfere with the results of the study. History of impaired renal function or elevated liver enzymes at prescreening. The exclusionary lab values are: 3x nl AST/ALT, 1.5x bilirubin or eGFR less than 30 ml/min. Having present or past medical conditions, including a DSM-5 Axis I psychiatric disorder, history of cardiac disease, arrhythmias, neurological disease of central origin, head trauma, and seizures.
5. Hypersensitivity: Individuals with known hypersensitivity to CBD or any component of the study formulation.

Primary outcomes:
measure: Cognitive Function: The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-COG)
timeFrame: 6 months
measure: Psychological well-being/ assesses psycho-behavioral symptomatology (the Neuropsychiatric Inventory NPI scoring system)
timeFrame: 6 months
measure: Sleep quality, latency, duration, efficiency, disturbances, and daytime dysfunction, evaluated using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months
measure: Overall quality of life (QOL-AD Questionnaire)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Hospital Sultan Abdul Aziz Shah
state: Selangor
Study officials:
References: