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NCT01608217

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

Completed Phase 2 Last updated 26 June 2014
What this trial tests

Phase 2 trial testing delta-9-tetrahydrocannabinol (delta-THC) in Behavioural Disturbances in 50 participants. Completed in 1 June 2014.

Timeline
1 June 2012
Primary endpoint
1 June 2014
1 June 2014

Quick facts

Lead sponsorRadboud University Medical Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment50
Start date1 June 2012
Primary completion1 June 2014
Estimated completion1 June 2014
Sites2 locations across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Radboud University Medical Center

Who can join

40 and older, any sex, with Behavioural Disturbances or Pain. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tetrahydrocannabinol for neuropsychiatric symptoms in dementia: A randomized controlled trial.
    van den Elsen GA, Ahmed AI, Verkes RJ, Kramers C, et al · · 2015 · cited 93× · PMID 25972490 · DOI 10.1212/wnl.0000000000001675
  2. Repurposed agents in the Alzheimer's disease drug development pipeline.
    Bauzon J, Lee G, Cummings J. · · 2020 · cited 46× · PMID 32807237 · DOI 10.1186/s13195-020-00662-x
  3. Clinical Trials of New Drugs for Vascular Cognitive Impairment and Vascular Dementia.
    Linh TTD, Hsieh YC, Huang LK, Hu CJ. · · 2022 · cited 39× · PMID 36232368 · DOI 10.3390/ijms231911067
  4. The neuroprotective effect of traditional Chinese medicinal plants-A critical review.
    Moreira J, Machado M, Dias-Teixeira M, Ferraz R, et al · · 2023 · cited 38× · PMID 37655317 · DOI 10.1016/j.apsb.2023.06.009
  5. Management of Dementia-Related Psychosis, Agitation and Aggression: A Review of the Pharmacology and Clinical Effects of Potential Drug Candidates.
    Marcinkowska M, Śniecikowska J, Fajkis N, Paśko P, et al · · 2020 · cited 37× · PMID 32052375 · DOI 10.1007/s40263-020-00707-7
  6. Cannabinoids for the treatment of dementia.
    Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, et al · · 2021 · cited 28× · PMID 34532852 · DOI 10.1002/14651858.cd012820.pub2
  7. A perspective on Alzheimer's disease: exploring the potential of terminal/paradoxical lucidity and psychedelics.
    Lin C, Du X, Wang X, Wang X. · · 2024 · PMID 39396013 · DOI 10.1186/s13024-024-00761-5

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