Cannabidiol's Role in Dementia Management

Launched by HOSPITAL PENGAJAR UNIVERSITI PUTRA MALAYSIA · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how cannabidiol (CBD), a compound found in cannabis, can help people with dementia. Researchers in Malaysia want to see if CBD can improve thinking skills, daily activities, mental health, and overall quality of life for patients suffering from dementia. The study will use various tools to measure these effects, and the results could lead to new ways to treat dementia, not just in Malaysia, but around the world.

To join this study, participants need to be 50 years or older and have a confirmed diagnosis of mild to severe dementia. It’s important that their condition is stable, meaning they haven’t had any major changes recently. Caregivers must also be involved, providing consent and helping with the study procedures. Participants can expect to take CBD in a controlled setting, and their progress will be monitored closely. However, individuals with certain health issues or those currently using specific medications will not be eligible to join. This ensures the safety and reliability of the study.

Gender

ALL

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.