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

Azienda Ospedaliero-Universitaria Maggiore Della Carita0 个研究点目标入组 186 人开始时间: 2024年4月23日最近更新: 2024年7月22日

适应症

试验速览

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•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.

•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).

发起方

Azienda Ospedaliero-Universitaria Maggiore Della Carita