Delta-THC in Dementia

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Health Valley, Netherlands
• Treatments: Acetaminophen; Dronabinol

Criteria

Inclusion Criteria:

• Subject has possible or probable dementia, type Alzheimer, vascular or mixed type dementia, according to the criteria of NINCDS-ADRDA/NINCDS-AIREN or based on an expert panel decision.

• Clinical Dementia Rating (CDR) score 1 to 3 (mild to severe dementia).

• Age ≥ 40 years.

• Clinically relevant behavioral disturbances existing at least one month prior to screening, defined as a score of ≥ 10 on the NPI, including presence of the domain agitation/aggression or motor disturbance.

• Women should be in the postmenopausal phase.

• Availability of an informal or formal caregiver, being in touch with the subject at least twice a week.

• Informed consent by the subject and subject's informal caregiver.

• If applicable: subject is willing to stop his/her own pain medication, for the duration of the study.

Exclusion criteria:

• Dementia other than AD, VaD or AD/VaD

• Major psychiatric disorder such as: major depression according to DSM IV within 6 months prior to randomization, history of psychosis or mania, current hallucinations and/or delirium, current suicidal ideation or major anxiety disorder.

• History of, or current drug abuse.

• Current alcohol abuse or unwillingness to use no more than 2 alcoholic consumptions daily or raised gamma-glutamine transpeptidase and alkaline phosphatase .

• Clinical or biochemical evidence of liver disease (ALT or AST ≥ twice the upper limit of normal) or known allergy to acetaminophen.

• Severe (and/or unstable) concomitant or intercurrent illness, such as seizure, arrhythmias requiring other drugs than a beta blocker or digoxin (except sinus arrhythmia and atrial fibrillation), unstable angina pectoris, heart failure NYHA III or IV, and severe concomitant illness that requires treatment changes.

• Known or suspected sensitivity to cannabinoids.

• Lactosis intolerance.

• Frequent falling due to orthostatic hypotension.

• Use of tricyclic antidepressants (TCA), fluoxetine and/or carbamazepine.

• Changes in dosage of antipsychotics, benzodiazepines or cholinesterase inhibitors within 2 weeks prior to intervention.

• Participation in any other study other than the descriptive 'Parelsnoer' study.