MEDICAL CANNABIS TREATMENT IN NEURODEGENERATIVE DISEASES (NEUROBIS)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 186

Inclusion Criteria

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 Criteria

Current significant cardiovascular disease (e.g., uncontrolled hypertension, clinically significant ischemic heart disease, clinically significant arrhythmia or severe heart failure)., Clinically significant delusions and/or hallucinations., Pregnancy and breastfeeding., Inability to provide inform consent., Chronic infections (HBV, HCV, HIV, tuberculosis), 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., Orthostatic hypotension., Presence or history of other psychiatric disorders or neurological conditions (e.g., psychotic disorders, schizophrenia, epilepsy, attempted suicide, depression), Alcohol and drug abuse., Current use of cannabinoids or previous or current abuse or dependence on marijuana., Contraindications to cannabidiol (history of hypersensitivity to any cannabinoid)., Change in psychotropic medications less than 1 month prior to study inclusion (e.g., concomitant antidepressants).