Evidence map›Paper›PMID 31338476›Full record

ArticleContemporary clinical trials communications2019

Investigating the safety and efficacy of nabilone for the treatment of agitation in patients with moderate-to-severe Alzheimer's disease: Study protocol for a cross-over randomized controlled trial.

Myuri T Ruthirakuhan, Nathan Herrmann, Damien Gallagher, Ana C Andreazza, Alexander Kiss, Nicolaas Paul L G Verhoeff, Sandra E Black, Krista L Lanctôt

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02351882 (Safety and Efficacy of Nabilone in Alzheimer's Disease), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 13% 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.

NCT02351882 phase2 / phase3completednot on this map

Safety and Efficacy of Nabilone in Alzheimer's Disease: a Pilot Study

TypeinterventionalSponsorSunnybrook Health Sciences CentreRan2015 to 2019Enrolled38ConditionsAlzheimer Disease, Agitation, Weight Loss, PainArmsNabilone, Placebo
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Cannabinoids for the treatment of dementia.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
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.

Myuri T RuthirakuhanHurvitz Brain Sciences Program, Sunnybrook Research Institute, 2075 Bayview Avenue, M4N 3M5, Toronto, ON, Canada.
Nathan HerrmannHurvitz Brain Sciences Program, Sunnybrook Research Institute, 2075 Bayview Avenue, M4N 3M5, Toronto, ON, Canada.
Damien GallagherGeriatric Psychiatry, Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, M4N 3M5, Toronto, ON, Canada.
Ana C AndreazzaDepartment of Pharmacology, University of Toronto, 1 King's College Circle, M5S 3K1, Toronto, ON, Canada.
Alexander KissDepartment of Research Design and Biostatistics, Sunnybrook Research Institute, 2075 Bayview Avenue, M4N 3M5, Toronto, ON, Canada.
Nicolaas Paul L G VerhoeffDepartment of Psychiatry, University of Toronto, 1 King's College Circle, M5S 3K1, Toronto, ON, Canada.
Sandra E BlackHurvitz Brain Sciences Program, Sunnybrook Research Institute, 2075 Bayview Avenue, M4N 3M5, Toronto, ON, Canada.
Krista L LanctôtHurvitz Brain Sciences Program, Sunnybrook Research Institute, 2075 Bayview Avenue, M4N 3M5, Toronto, ON, Canada.
Sunnybrook Health Science Centre · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Agitation is a prevalent and difficult-to-treat symptom in patients with moderate-to-severe Alzheimer's disease (AD). Though there are nonpharmacological and pharmacological interventions recommended for the treatment of agitation, the efficacy of these are modest and not always consistent. Furthermore, the safety profiles of currently prescribed medications are questionable. Nabilone, a synthetic cannabinoid, has a distinct pharmacological profile that may provide a safer and more effective treatment for agitation, while potentially having benefits for weight and pain. Additionally, emerging evidence suggests nabilone may have neuroprotective effects. We describe a clinical trial investigating the safety and efficacy of nabilone for the treatment of agitation in patients with moderate-to-severe AD. This will be a double-blind, randomized cross-over study comparing 6 weeks of nabilone (0.5-2 mg) and placebo, with a 1-week washout preceding each phase. Study outcomes will be measured at baseline and end of treatment for each treatment phase. The primary outcome measure will be agitation as assessed by the Cohen-Mansfield Agitation Inventory. The secondary outcomes include safety, behaviour (Neuropsychiatric Inventory), cognition (standardized Mini Mental Status Exam and either Severe Impairment Battery or Alzheimer's disease Assessment Scale-Cognitive subscale) and global impression (Clinician's Global Impression of Change). Exploratory outcomes include pain (Pain Assessment in Advanced AD), nutritional status (Mini-Nutritional Assessment-Short Form), caregiver distress (NPI caregiver distress), and blood-based biomarkers. A safe and efficacious pharmacological intervention for agitation, with effects on pain and weight loss in patients with moderate-to-severe AD could increase quality-of-life, reduce caregiver stress and avoid unnecessary institutionalization and related increases in health care costs. CLINICAL TRIALS NUMBER: NCT02351882.

Indexed as

AD, Alzheimer's diseaseAgitationAlzheimer's diseaseCannabinoidCB1, cannabinoid receptor 1CB2, cannabinoid receptor 2CB, cannabinoidsCGIC, Clinician's Global Impression of ChangeClinical trialCMAI, Cohen Mansfield Agitation InventoryEC50, half maximal effective concentrationFDA, Food and Drug AdministrationIPA, International Psychogeriatric AssociationLTC, long-term careMAR, Medication Administration RecordMNA-SF, Mini-Nutritional Assessment-Short formNeuropsychiatric symptomsNPI-NH, Neuropsychiatric Inventory-Nursing home versionNPS, neuropsychiatric symptomsPAINAD, Pain Assessment in Advanced ADRCT, randomized controlled trialSIB, Severe Impairment BatterysMMSE, standardized Mini-Mental Status ExaminationTHC, tetrahydrocannabinol

Identifiers

PMID31338476
PMCPMC6627000
OpenAlexW2946781777

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.