NCT01608217

Delta-THC in Dementia

Efficacy and Safety of Delta-9-tetrahydrocannabinol (∆9-THC) in Behavioural Disturbances and Pain in Dementia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, randomized, placebo-controlled, double-blind, parallel-group, multicentre study to the efficacy and safety of low dose delta-9-THC in behavioural disturbances and pain in patients with mild to severe dementia, when added to an analgesic treatment with acetaminophen. It is hypothesized that Namisol® will lead to more behavioural disturbances than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period. It is expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living.

Detailed description

There is a high prevalence of behavioural disturbances (NPS) in persons with dementia. Persistent pain complaints can be a cause of NPS. Unfortunately, there is a lack of appropriate drugs for treating both these problems. This and positive suggestions from preliminary clinical studies with THC on NPS and directly fuel the study presented here. This will be a phase II study in which the efficacy and safety of Namisol® (a tablet with THC) on behavioural disturbances, such as agitation, aggression and motor disturbances in dementia patients will be evaluated. Secondary study objectives are : 2\. To evaluate the efficacy of Namisol® on other secondary outcome measures, such as quality of life and functioning in daily activities. 3\. To evaluate safety of Namisol® as assessed with physical examination, effects on cognitive functioning and adverse event monitoring. 4\. For the subgroup of subjects suffering from pain: to evaluate the efficacy of Namisol® pain intensity It is hypothesized that Namisol® will lead to more reduction in behavioural disturbances than placebo, when added to an analgesic treatment with acetaminophen, and as measured by a change in Neuropsychiatric Inventory (NPI) score, after a three week treatment period. It is expected that this will be due, primarily, to psychoactive effects of Namisol® and secondary to a reduction in pain sensation (as measured with VRS and PACSLAC-D). It is expected that a reduction in NPS will positively affect quality of life and lead to better functioning in daily living This is a randomized placebo-controlled double-blind parallel-group multicentre study. Subjects who appear to fulfill the eligibility criteria are informed about the study. After signing informed consent by the subject and/or caregiver, a screening visit will take place. Subjects who are eligible for participation enter a wash-out period, for discontinuation of their own analgesic medication (if applicable). Subjects will be randomly allocated to receive one of the two interventions (Namisol® 1.5 mg + acetaminophen 1000 mg three times daily, or placebo + acetaminophen 1000 mg three times daily) for a double-blind intervention period of three weeks. After two weeks the primary outcome measure (NPI) is assessed by a telephone interview with the caregiver. Subjects visit the site twice (at baseline and after three weeks treatment) for assessments of the outcome parameters, including the NPI. For the purpose of compliance and safety, there will be a weekly phone call, performed by the researcher. After completion of this period subject's own analgesic treatment will be restarted (if applicable). After a follow up phase of two weeks, the subject is contacted by telephone for assessment of adverse events.

Conditions

• Behavioural Disturbances
• Pain
• Dementia
• Alzheimer's Dementia
• Vascular Dementia

Interventions

Type	Name	Description
DRUG	delta-9-tetrahydrocannabinol (delta-THC)	delta-THC 1.5 mg (tablet)three times daily for a period of 3 weeks.
DRUG	Placebo	placebo (tablet) three times daily for a period of three weeks.
DRUG	Acetaminophen	Acetaminophen 1000 mg three times daily for a period of 3 weeks
DRUG	Acetaminophen	Acetaminophen 1000 mg three times daily for a period of three weeks

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-05-31
• Last updated: 2014-06-30

Locations

2 sites across 1 country: Netherlands