Evidence map›Paper›PMID 25972490›Full record

Trial reportNeurology2015

Tetrahydrocannabinol for neuropsychiatric symptoms in dementia: A randomized controlled trial.

Geke A H van den Elsen, Amir I A Ahmed, Robbert-Jan Verkes, Cees Kramers, Ton Feuth, Paul B Rosenberg, Marjolein A van der Marck, Marcel G M Olde Rikkert

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 11 pooled it
9.3field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

67 citing papers in PubMed, 11 syntheses or guidelines pooled it, 152 citations in OpenAlex.

  1. Efficacy and safety of cannabinoid-based interventions for behavioral and cognitive symptoms in dementia: systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
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  6. Cannabinoids for the treatment of dementia.The Cochrane database of systematic reviews · 2021
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  9. Cannabinoids for the Neuropsychiatric Symptoms of Dementia: A Systematic Review and Meta-Analysis.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2020
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  15. Neurotransmitter Systems in Alzheimer's Disease.Current issues in molecular biology · 2026
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7 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Geke A H van den ElsenFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD. geke.vandenelsen@radboudumc.nl.
Amir I A AhmedFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD.
Robbert-Jan VerkesFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD.
Cees KramersFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD.
Ton FeuthFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD.
Paul B RosenbergFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD.
Marjolein A van der MarckFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD.
Marcel G M Olde RikkertFrom the Departments of Geriatric Medicine/Radboudumc Alzheimer Centre (G.A.H.v.d.E., A.I.A.A., M.A.v.d.M., M.G.M.O.R.), Pharmacology and Toxicology (A.I.A.A., C.K.), Psychiatry (R.-J.V.), Internal Medicine (C.K.), and Health Evidence (T.F.), Radboud university medical center, Nijmegen; the Department of Elderly (A.I.A.A.), Vincent van Gogh Institute, Venray; the Department of Clinical Pharmacy (C.K.), Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands; and the Department of Psychiatry and Behavioral Sciences (P.B.R.), John Hopkins University School of Medicine, Baltimore, MD.
Canisius-Wilhelmina Ziekenhuis · NLVincent Van Gogh Voor Geestelijke Gezondheidszorg · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo study the efficacy and safety of low-dose oral tetrahydrocannabinol (THC) in the treatment of dementia-related neuropsychiatric symptoms (NPS).

methodsThis is a randomized, double-blind, placebo-controlled study. Patients with dementia and clinically relevant NPS were randomly assigned to receive THC 1.5 mg or matched placebo (1:1) 3 times daily for 3 weeks. Primary outcome was change in Neuropsychiatric Inventory (NPI), assessed at baseline and after 14 and 21 days. Analyses were based on intention-to-treat.

resultsTwenty-four patients received THC and 26 received placebo. NPS were reduced during both treatment conditions. The difference in reduction from baseline between THC and placebo was not significant (mean difference NPItotal: 3.2, 95% confidence interval [CI] -3.6 to 10.0), nor were changes in scores for agitation (Cohen-Mansfield Agitation Inventory 4.6, 95% CI -3.0 to 12.2), quality of life (Quality of Life-Alzheimer's Disease -0.5, 95% CI -2.6 to 1.6), or activities of daily living (Barthel Index 0.6, 95% CI -0.8 to 1.9). The number of patients experiencing mild or moderate adverse events was similar (THC, n = 16; placebo, n = 14, p = 0.36). No effects on vital signs, weight, or episodic memory were observed.

conclusionsOral THC of 4.5 mg daily showed no benefit in NPS, but was well-tolerated, which adds valuable knowledge to the scarce evidence on THC in dementia. The benign adverse event profile of this dosage allows study of whether higher doses are efficacious and equally well-tolerated. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with dementia-related NPS, low-dose THC does not significantly reduce NPS at 21 days, though it is well-tolerated.

Indexed as

Activities of Daily LivingAgedAged, 80 and overAggressionCannabinoid Receptor AgonistsDementiaDouble-Blind MethodDronabinolHumansMalePsychomotor AgitationQuality of LifeTreatment OutcomeCannabinoid Receptor AgonistsDronabinol

Identifiers

PMID25972490
PMCPMC4464746
OpenAlexW2099611723

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.