Research Article
Volume 14 Issue 5 - 2022
Parkinson’s Disease and Dementia with Lewy Bodies, Patients Under Treatment with Standardized Extracts Enriched in Cannabidiol and Cannabigerol: Descriptive Observations in Preparation for a Phase 2a Clinical Trial

Flávio Henrique de Rezende Costa1,2*, Simone Pellegrino1, Mariana Spitz3, Eduardo Rydz1, Gabriel de Castro Micheli1, Elio Tanaka4, Brian Michael Ebner5, Jaron Gladstone5 and Andrew J Lees6

1Health Meds Laboratories, Rio de Janeiro, Brazil

2Multidisciplinary Clinic, Botagofo, Rio de Janeiro, Brazil

3Estate University of Rio de Janeiro, Brazil

4TNK, Curitiba- Brazil

5CBCeuticals, Coral Springs, Flórida, USA

6Queen Square Brain Bank for Neurological Disorders, University College London Queen Square Institute of Neurology, London, UK

*Corresponding Author: Flávio Henrique de Rezende Costa, Health Meds Laboratories, Rio de Janeiro and Multidisciplinary Clinic, Botagofo, Rio de Janeiro, Brazil.
Received: December 29, 2021; Published: April 26, 2022




Abstract

Background: Cannabis-based formulations are now widely used by patients with neurological and psychiatric problems but no studies have been published on the clinical utility of CBD/CBG enriched extracts for parkinsonism's symptoms.

Objectives: To describe preliminary clinical data collection of PD and DLB patients under CBD/CBG medical prescription.

Methods: Review of electronic records of 14 PD and 5 DLB patients. Four extracts were available 1) CBD broad spectrum (100 mg/mL) 2) CBD/CBG broad spectrum (100 mg/mL 2:1) (3) CBD/CBG (2:1) + THC0.3% full spectrum (100mg/mL) 4) CBD+THC0.3% full spectrum (100 mg/mL). All the patients received authorization from ANVISA (Brazil) to import the formulations for medical use. Outcomes of each unmet need (UMN) were tabulated and graded.

Results: Demographics: PD N = 14 (10 male). DLB: N = 5 (3 male). Mean age: PD: 76.2 yrs. (46 - 94). DLB: 82.2 yrs. (83 - 92). Disease duration: PD (6.57 yrs.), DLB (4.2 yrs.); PD H/Y stage (3); PD levodopa dose: 490 mg (150 - 900). Mean daily doses: PD CBD: 65.17 mg (8.33 – 125 mg), CBG: 22,50 mg (4.16 - 50 mg), THC: 2,32 mg (0,75 - 4,5 mg). DLB CBD: 52 mg (5 - 100 mg). CBG: 8,75 mg (2,5 - 15 mg), THC: 0,225 mg. Positive results were seen for RBD, insomnia, anxiety, and pain. All pain responders were on CBG and/or THC formulations. Hallucinations were also attenuated in both patient groups. Safety and tolerability were favorable in this small sample.

Conclusions: Future clinical trials in Parkinson’s disease and DLB with cannabinoids should focus on their potential benefit for associated anxiety, and pain. The potential anti-psychotic effects of CBD and CBD/CBG  should also be further evaluated in a phase 2a clinical trial.

 

Keywords: Cannabidiol; Cannabigerol; Parkinson’s Disease; Dementia With Lewy Bodies; Medical Cannabis

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Citation: Flávio Henrique de Rezende Costa., et al. “Parkinson’s Disease and Dementia with Lewy Bodies, Patients Under Treatment with Standardized Extracts Enriched in Cannabidiol and Cannabigerol: Descriptive Observations in Preparation for a Phase 2a Clinical Trial”. EC Neurology 14.5 (2022): 01-15.

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