←Dementia
Study register · detail Open-label Pilotstudie · Dementia · 2016

Safety and Efficacy of Medical Cannabis Oil for Behavioral and Psychological Symptoms of Dementia: An-Open Label, Add-On, Pilot Study

Shelef et al. ·Journal of Alzheimer's Disease Impact 2.7
Clear benefit GRADE Low 104 citations
Samplen = 10 Pat.
Duration4 weeks
EndpointNPI
Blindingoffen
DesignOpen-label Pilotstudie
Cannabinoidthc
Routeoral
Key finding

MCO add-on therapy significantly reduced NPI and CGI scores in Alzheimer's patients within 4 weeks.

Summary

n=10 Alzheimer's patients, open-label pilot add-on study with medical cannabis oil (MCO/THC). CGI severity from 6,5 to 5,7 (p<0,01), NPI score from 44,4 to 12,8 (p<0,01). Significant improvement in NPI domains delusions, agitation, irritability, apathy, sleep and caregiver distress.

P
PopulationAlzheimer's patients with behavioural and psychological symptoms of dementia (BPSD), n=10 (completed)
I
InterventionMedical cannabis oil (MCO) with THC, oral, add-on to existing pharmacotherapy
O
OutcomeSignificant reduction in NPI score (44,4 to 12,8; p<0,01) and CGI severity score (6,5 to 5,7; p<0,01)
Confidence in the evidence
Low

The second of four GRADE levels, the effect estimate is of limited reliability.

Downgraded for
Risk of biasImprecision
Quality profile
Sample size ★★★★★
Blinding Open-label
Effect size Clear benefit
Citations / year ★★★★★
Authors
Shelef A, Barak Y, Berger U et al.
DOI 10.3233/jad-150915↗
Design: Open-label Pilotstudie
Share
Abstract
<h4>Background</h4>Tetrahydrocannabinol (THC) is a potential treatment for Alzheimer's disease (AD).<h4>Objective</h4>To measure efficacy and safety of medical cannabis oil (MCO) containing THC as an add-on to pharmacotherapy, in relieving behavioral and psychological symptoms of dementia (BPSD).<h4>Methods</h4>Eleven AD patients were recruited to an open label, 4 weeks, prospective trial.<h4>Results</h4>Ten patients completed the trial. Significant reduction in CGI severity score (6.5 to 5.7; p < 0.01) and NPI score were recorded (44.4 to 12.8; p < 0.01). NPI domains of significant decrease were: Delusions, agitation/aggression, irritability, apathy, sleep and caregiver distress.<h4>Conclusion</h4>Adding MCO to AD patients' pharmacotherapy is safe and a promising treatment option.
Indication
Further studies on Dementia
All studies →
S Bosnjak Kuharic et al. · 2021 · Cochrane Database of Systematic Reviews
52 citations
Cannabinoids for the treatment of dementia
No benefit demonstrated Cochrane Systematic Review

Cochrane SR über k=4 RCTs (n=126) zu Cannabinoiden bei Demenz; überwiegend Alzheimer-Demenz, einzelne Fälle vaskuläre/gemischte Demenz. Drei Studien mit niedrigem Bias-Risiko. Review bewertet Wirksamkeit und Sicherheit von Cannabinoiden bei Demenz-Behandlung (Abstract unvollständig abgeschnitten — quantitative Outcomes nicht im verfügbaren Text).

10.1002/14651858.cd012820.pub2 View study →
A Doppen et al. · 2022 · Journal of pain and symptom management
44 citations
Cannabis in Palliative Care: A Systematic Review of Current Evidence.
Mixed Systematic Review

Systematische Review zu medizinischem Cannabis im Palliativbereich; k=52 Studien (20 RCTs, 32 nicht-randomisiert), n=4.786 Teilnehmende (Krebs n=4.491, Demenz n=43, AIDS n=235, Spastik n=16, NORSE n=1). Für Demenz: positive Behandlungseffekte (p<0,05) für Appetit und Agitation. Evidenzqualität 'sehr niedrig' oder 'niedrig' für alle Studien. Meta-Analyse nicht durchführbar wegen Heterogenität der Cannabis-Produkte und Outcomes. Hochwertiger Evidenzbedarf für klinische Empfehlungen.

10.1016/j.jpainsymman.2022.06.002 View study →
A van den Elsen et al. · 2014 · Ageing research reviews
110 citations
Efficacy and safety of medical cannabinoids in older subjects: a systematic review.
Mixed Systematic Review

Systematische Review zu medizinischen Cannabinoiden bei älteren Personen (≥65 Jahre); k=5 RCTs mit separaten Daten zu Älteren (n=267, Alter 47-78 Jahre). Interventionen: orales THC (k=3) oder THC+CBD (k=2). Zwei Studien zeigten möglichen Nutzen von THC bei Anorexie und Verhaltenssymptomen bei Demenz. Keine Wirksamkeit bei Dyskinesie, Atemnot oder Chemotherapie-induzierter Übelkeit. Unerwünschte Ereignisse (v.a. Sedierung) häufiger unter Cannabinoid-Behandlung vs. Kontrolle.

10.1016/j.arr.2014.01.007 View study →

The impediment to action advances action. — Marcus Aurelius