Delta-THC in Behavioral Disturbances in Dementia

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Radboud University
• Collaborator: European Union
• Treatments: Dronabinol

Criteria

Inclusion Criteria:

• Diagnosis of Alzheimer's Disease (AD), Vascular Dementia (VD) or mixed, according to the criteria of NINCDS-ADRDA or NINCDS-AIREN

• Clinical Dementia Rating score between 0.5 and 3

• NPS symptoms, with at least agitation or aggression

Exclusion Criteria:

• Diagnosis of Lewy Body Dementia (LBD) or Fronto-Temporal Dementia (FTD)

• Major psychiatric disorder

• Severe concomitant illness, seizure, arrhythmias (except sinus arrhythmia and atrial fibrillation), heart failure New York Heart Association (NYHA) class III or IV

• Tri Cyclic Antidepressives (TCA) or opioids used within 30 days before randomization till the end of the study

• Changes in dosage of antidepressives within 6 weeks before randomization and during study, and changes in dosage antipsychotics or benzodiazepines within 2 weeks prior to randomization and during study