Dementia Clinical Trial
Official title:
Two Phase, Repeated Crossover Study With Dose Escalation on Delta(9)-Tetrahydrocannabinol (Delta-THC) in Behavioral Disturbances in Dementia
Dementia is a common chronic condition, with predicted increasing prevalence. Nearly all patients with dementia will experience neuropsychiatric symptoms (NPS). This causes significant burden for the individual patients and their caregivers. Current treatment has only modest efficacy and important side-effects. Formulations with Δ9-tetrahydrocannabinol (THC), the psycho-active compound of cannabis, are currently being registered for spasms in multiple sclerosis and other diseases, and may have beneficial effects on NPS.
Design Phase II pilot study, multi-center, repeated cross-over, double blinded randomized
trial. The study consists of two weeks baseline measurements to assure that the
neuropsychiatric symptoms are stable and six successive treatment blocks of 2 weeks. Each
treatment block lasts for two weeks and contains two double-blinded drug periods, each
lasting three days of oral THC or placebo, separated by four day washout periods. After
three treatment blocks (period A), the dosage of active treatment was increased for the
latter three treatment blocks (period B). After the two treatment periods, subjects will
proceed to the extension phase if applicable.
Study centers The department of Geriatrics from Radboud University Nijmegen Medical Centre
and the department of Elderly from Vincent van Gogh voor Geestelijke Gezondheidszorg Venray
(VVG) will participate in this multi center study.
Participants 20 subjects with dementia and NPS. Intervention Namisol® in doses of twice
daily 0,75 mg tablet (period A) and twice daily 1.5 mg (period B) THC oral tablets. Placebo
of twice daily 0,75 mg and twice daily 1.5 mg oral tablets Outcome measures Primary outcome
is NPI score, secondary CMAI, Zarit Burden scale. Other outcomes include vital signs,
side-effects, physical exam, mobility and pharmacogenetics.
Visits This study will be assessed fully ambulatory, starting with a 5 hour clinical visit
on day 1 and 8 of block 1 and a phone call on day 2 and 9 for assessment of Adverse Events.
Furthermore, the research physician will conduct a weekly home visit weekly during the
crossover phase for assessment of , among others, the primary outcome measure. These visits
will all be repeated in period B of the crossover phase.
During the 6 month open label extension phase, subjects will visit the clinic three times.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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