MEDICAL CANNABIS TREATMENT IN NEURODEGENERATIVE DISEASES (NEUROBIS)

Trial details

Who runs it

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Trial code

EU 2023-507715-35-02

Record updated

2024. július 17.

Original description

It will be determined whether the use of a balanced THC/CBD extract (cannabis extract Avextra 10/10 oral solution) is safe and suitable for contributing to a significant improvement in quality of life (QoL) in patients with a neurodegenerative disease (Alzheimer’s disease (AD), Parkinson’s disease (PD), or Amyotrophic Lateral Sclerosis (ALS).Read full original descriptionShow less

MEDICAL CANNABIS FOR NEURODEGENERATIVE DISEASES: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II CLINICAL TRIAL (NEUROBIS)

It will be determined whether the use of a balanced THC/CBD extract (cannabis extract Avextra 10/10 oral solution) is safe and suitable for contributing to a significant improvement in quality of life (QoL) in patients with a neurodegenerative disease (Alzheimer’s disease (AD), Parkinson’s disease (PD), or Amyotrophic Lateral Sclerosis (ALS).

To demonstrate for the total study population (all 3 neurodegenerative diseases) superiority with regards to improving Quality of Life, assessed with the Short Form 36 Health Survey (SF-36), compared to placebo.

To assess for the total study population the safety and tolerability, incidence of treatment-emergent adverse events (TAEDs) and discontinuation rate of cannabis extract Avextra 10/10 compared to placebo.

Inclusion: For all patients: ability to give written informed consent personally or, as an alternative, via a legally authorized representative. Patients >55years aged; Alzheimer's Disease (AD): age diagnosis of AD based on the DSM-5 criteria for Major Neurocognitive Disorder due to AD; MMSE ≤ 24; presence of clinically significant agitation (Neuropsychiatric Inventory-agitation subscale ≥3). If treated with cognitive-enhancing medications (cholinesterase inhibitors (ChEIs) and/or memantine), the dosage must be stable for at least 3 months. If the ChEI and/or memantine have been discontinued, they may enroll after one month; Amyotrophic Lateral Sclerosis (ALS): diagnosis of definite or probable according to El Escorial Criteria, documented progression of the disease in the last three months as measured by the ALSFRS-R scale (decrease of at least one point); age FVC ≥60% of predicted; treatment with riluzole 50 mg twice/day for at least one month before the screening visit; Parkinson's Disease (PD): diagnosis of idiopathic Parkinson’s disease; modified Hoehn and Yahr stage 1 to 4; able to walk > 10 mt without aids or assistance; in treatment with L-Dopa with a stable dosage for at least 30 days.

Exclusion: Alcohol and drug abuse; Current use of cannabinoids or previous or current abuse or dependence on marijuana; Change in psychotropic medications less than 1 month prior to study inclusion (e.g., concomitant antidepressants); Current significant cardiovascular disease (e.g., uncontrolled hypertension, clinically significant ischemic heart disease, clinically significant arrhythmia or severe heart failure); Chronic infections (HBV, HCV, HIV, tuberculosis); Presence or history of other psychiatric disorders or neurological conditions (e.g., psychotic disorders, schizophrenia, epilepsy, attempted suicide, depression); Contraindications to cannabidiol (history of hypersensitivity to any cannabinoid); Renal (serum creatinine > 2 mg/dl or creatinine clearance < 30 mL/min according to Cockcroft-Gault formula) and hepatic (ALT, AST, GGT, alkaline phosphatase > 2.5 ULN) failure; Clinically significant delusions and/or hallucinations; Pregnancy and breastfeeding; Inability to provide inform consent; Orthostatic hypotension.

EU CTIS 2023-507715-35-02