←Parkinson Disease
Study register · detail RCT · Parkinson Disease · 2023

Cognitive Safety Data from a Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase IIb Study of the Effects of a Cannabidiol and Delta9-Tetrahydrocannabinol Drug on Parkinson's Disease-Related Motor Symptoms.

Domen et al. ·Movement disorders Impact 3.9
Harm GRADE Moderate 33 citations
Samplen = 58 Pat.
Duration16.3 days
ControlPlacebo
EndpointAnimal Verbal Fluency Test
Blindingdoppelblind
DesignRCT
Cannabinoidkombination
THC:CBD1:30.3
Max. dose206.6 mg
Routeoral
Key finding

The CBD/THC group showed worse performance in Animal Verbal Fluency and reported cognitive adverse events at least twice as often as the placebo group.

Summary

n=58 (CBD/THC n=29, placebo n=29), randomized, double-blind phase IIb study of high-dose CBD (100 mg) + low-dose THC (3,3 mg) in Parkinson's disease over an average of 16,3 days. Primary outcome: cognitive safety. CBD/THC group showed worse performance in the Animal Verbal Fluency Test vs. placebo (adjusted for age/education, p<0,05); cognitive adverse events at least twice as frequent as under placebo.

P
PopulationAdults with Parkinson's disease, n=58 (CBD/THC: n=29, placebo: n=29)
I
InterventionOral CBD/THC preparation (CBD 100 mg + THC 3,3 mg), twice daily, escalating dosing schedule
C
ControlPlacebo (oral, double-blind)
O
OutcomeCBD/THC group showed worse performance in the Animal Verbal Fluency Test vs. placebo (after adjustment for age and education); cognitive adverse events at least twice as frequent in the CBD/THC group
Confidence in the evidence
Moderate

The third of four GRADE levels, the effect estimate is probably reliable.

Downgraded for
Imprecision
Quality profile
Sample size ★★★★★
Blinding Double-blind
Effect size Harm
Citations / year ★★★★★
Authors
Domen CH, Sillau S, Liu Y, Adkins M, Rajkovic S, Bainbridge J, Sempio C, Klawitter J, Leehey MA
DOI 10.1002/mds.29447↗
Design: RCT
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Abstract
Background: Cannabis is increasingly available worldwide but its impact on cognition in Parkinson's disease (PD) is unknown. Objective: Present cognitive safety data from study of an oral high-dose cannabidiol (CBD; 100 mg) and low-dose Delta9-tetrahydocannabinol (THC; 3.3 mg) drug in Pd. Methods: Randomized, double-blind, parallel-group, placebo-controlled study of a CBD/THC drug administered for 16.3 (SD: 4.2) days, with dosage escalating to twice per day. Neuropsychological tests were administered at baseline and 1-1(1/2) hours after final dose; scores were analyzed with longitudinal regression models (alpha = 0.05). Cognitive adverse events were collected. Results: When adjusted for age and education, the CBD/THC group (n = 29) performed worse than the placebo group (n = 29) on Animal Verbal Fluency. Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group. Conclusion: Data suggest this CBD/THC drug has a small detrimental effect on cognition following acute/short-term use in PD. (c) 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
Indication
Further studies on Parkinson Disease
All studies →
A Figura et al. · 2022 · Neurologia i neurochirurgia polska
19 citations
Cannabis in Parkinson's Disease - the patient's perspective versus clinical trials: a systematic literature review.
No benefit demonstrated Systematic Review

Systematische Review zu Cannabis bei Parkinson; k=7 randomisierte Studien identifiziert. Ergebnisse unterstützen KEINE Wirksamkeit von Cannabinoiden bei motorischen Symptomen der Parkinson-Krankheit. Schlussfolgerung: derzeit unzureichende Datenlage für Cannabinoid-Einsatz bei PD-Patienten.

10.5603/pjnns.a2022.0004 View study →
A Liu et al. · 2024 · Movement disorders
19 citations
Short-Term Cannabidiol with Delta-9-Tetrahydrocannabinol in Parkinson's Disease: A Randomized Trial.
No benefit demonstrated RCT

RCT n=61 (CBD/THC n=31, Placebo n=30), 2 Wochen Titration auf finale Dosis 191,8±48,9 mg CBD + 6,4±1,6 mg THC täglich. Primärer Endpunkt motor MDS-UPDRS: Reduktion -4,57 (95% CI -8,11 bis -1,03; p=0,013) in CBD/THC-Gruppe vs. -2,77 (-4,92 bis -0,61; p=0,014) in Placebo; Gruppen-Differenz nicht signifikant: -1,80 (-5,88 bis 2,27; p=0,379). Kein Benefit, möglicherweise verschlechterte Kognition und Schlaf; starker Placebo-Effekt. Nebenwirkungen mild, häufiger in CBD/THC-Gruppe.

10.1002/mds.29768 View study →
A Peball et al. · 2020 · Annals of neurology
118 citations
Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone.
Mixed RCT

Phase-II-RCT, n=47 Parkinson-Patienten mit stabiler Motorik aber störenden Non-Motor-Symptoms (NMS, MDS-UPDRS-I ≥4). Open-label Nabilone-Titration (0,25–1 mg 2×/d), dann Randomisierung Responder zu Nabilone vs. Placebo (n=19). Primärer Endpunkt MDS-UPDRS-I nach 4 Wochen: Placebo-Gruppe verschlechterte sich um 2,63 Punkte (95% CI 1,53–3,74, p=0,002), Nabilone-Gruppe nur um 1,00 Punkte (95% CI −0,16–2,16, p=0,280); Differenz 1,63 Punkte (95% CI 0,09–3,18, p=0,030, Effektgröße 0,66). Positive Effekte v.a. auf Angst und nächtliche Schlafprobleme. 77% AEs in Titrationsphase (meist transient), keine schwerwiegenden AEs.

10.1002/ana.25864 View study →

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