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Delta-THC in Dementia

NCT01608217 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-06-30

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Health Valley, Netherlands

    collaborator NETWORK

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Marcel Olde Rikkert, prof. dr. · Radboud University Medical Center Nijmegen

  • Willem Verhoeven, Prof. dr. · Vincent van Gogh voor Geestelijke Gezondheidszorg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01608217 on ClinicalTrials.gov