None listed
Conditions
Brief summary
The study aims to investigate the potential therapeutic benefits of cannabidiol (CBD) as a treatment for brain changes and depression in individuals living with early-stage dementia. Accumulating evidence suggests that CBD is a novel, well tolerated medicine with beneficial neurorepair, hormone and symptom regulating effects and it may therefore be a promising candidate to address multiple facets of dementia. However, no trial to date has investigated the effects of pure CBD in people with early-stage dementia. The trial design includes 60 participants randomised to one of two treatment arms (30 CBD, 30 placebo), who will take a daily 300mg dose of their respective capsules for 12 weeks. A comprehensive range of outcome measures will be assessed at baseline, mid- point and post-treatment. It is anticipated that treatment with CBD will lead to improvements in neural structure, cognitive function, psychological symptoms and hormone profiles.
Interventions
The intervention of interest is cannabidiol (CBD). For the intervention group, medical grade 99.9% pure CBD will be formulated into capsules for oral administration. Each CBD capsule will contain either 100mg or 200mg CBD powder solved in Softisan 378 gelatin capsules. Participants will take two capsules per day. Participants will commence the trial on a daily dose of 200mg/day for the first two weeks, which involves taking one 100mg capsule in the morning and one 100mg capsule in the evening, w
The intervention of interest is cannabidiol (CBD). For the intervention group, medical grade 99.9% pure CBD will be formulated into capsules for oral administration. Each CBD capsule will contain either 100mg or 200mg CBD powder solved in Softisan 378 gelatin capsules. Participants will take two capsules per day. Participants will commence the trial on a daily dose of 200mg/day for the first two weeks, which involves taking one 100mg capsule in the morning and one 100mg capsule in the evening, with food. If no adverse effects are reported, then the daily dose will be escalated to 300mg/day for the remaining ten weeks of the trial - the evening dose will be increased to 200mg, with the morning dose remaining at 100mg. If an adverse event is reported at 200mg, participants will be discontinued from the trial. Medication adherence will be assessed primarily by blood test to measure CBD concentrations in plasma. A supporting person, nominated by the participant, will further assist with medication adherence by recording when capsules are taken and by returning medication containers each week when new weekly doses are provided.
Sponsors
University of Wollongong
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Community-dwelling individuals who can provide written informed consent, with a clinician confirmed primary diagnosis of early dementia made within the past 24 months. Participants must have a nominated supporting person, preferably living with them (e.g. spouse) who can assist with daily medication monitoring. 2. A Stage 3-5 rating on the Global Deterioration Scale (GDS) 3. A score of 20-26 on the Mini Mental State Exam (MMSE); 4. If taking general medications (e.g. Micardis, Advil), participants must have been taking them for a minimum of 6-12 weeks prior to the start of the trial, with no changes to medication regime during the 12-week trial period unless clinician-recommended changes are required for appropriate care.
Exclusion criteria
Participants will be excluded on the basis of: 1. MRI contraindications, such as severe head injury, pace devices, coronary or peripheral artery stents, cochlear implants, renal insufficiency or claustrophobia; 2. Allergies to the excipient used in the formulation of the capsules; 3. Impaired liver or kidney or heart function; 4. Active suicidal ideation; 5. Intake of CBD, THC or cannabis within one month prior to participation; 6. Prior extensive use of CBD, defined as use greater than weekly for more than 3 months in the two years prior to participation; 7. A clinically relevant history of recreational cannabis use or other drugs of abuse, defined as more than three times a week for any continuous period of longer than 6 months in duration in the year prior to participation; 8. Prior history of treatment for alcohol use disorder in the year prior to participation, or a current score of 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT); 9. Any current or recent diagnoses of neurological disorders other than dementia, including epilepsy or Parkinson’s disease; 10. Current use of medications that have clinically relevant interactions with the cytochrome P450 (CYP) 2C19 or CYP3A classes of liver enzymes prior to study inclusion (e.g. antipsychotics, antidepressants, anxiolytics); 11. Participation in any other clinical drug trials within 30 days of the current study; 12. Anticipated surgical needs within 3 months of participation.
Outcome results
None listed