Alzheimer’s Disease (AD) and Parkinson’s Disease (PD)., Patients suffering from neurodegenerative diseases: Amyotrophic Lateral Sclerosis (ALS)
Conditions
Brief summary
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.
Detailed description
To demonstrate for the total study population (all 3 neurodegenerative diseases) superiority with regards to improving caregiver distress as assessed by a structured interview by an expert neuropsychologist using the Zarit Burden Interview (22-items) and the Caregiving Distress Scale., To demonstrate for the total study population (all 3 neurodegenerative diseases) superiority with regards to improving a patient-reported outcome measure evaluated through the Patient Global Impression of Change (PGIC) compared to placebo., To demonstrate in the subpopulation of patients with Alzheimer’s disease (AD) superiority with regards to improvements on specific clinical disease marker functional disability using the standardized Mini Mental Status Examination (MMSE) to evaluate the cognitive functions and the Neuropsychiatric Inventory-agitation subscale for agitation in AD., To demonstrate in the subpopulation of patients with Amyotrophic Lateral Sclerosis superiority with regards to improvements on specific clinical disease marker functional disability using the ALS functional rating scale - revised (ALSFRS-R) score for functional status in ALS., To demonstrate in the subpopulation of patients with Parkinson’s disease superiority with regards to improvements on specific clinical disease marker functional disability using the unified Parkinson's disease rating scale (UPDRS) for monitoring the longitudinal course of PD.
Interventions
DRUGMixture of Sesame oil / Linseed oil (9:1)
Sponsors
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate for the total study population (all 3 neurodegenerative diseases) superiority with regards to improving caregiver distress as assessed by a structured interview by an expert neuropsychologist using the Zarit Burden Interview (22-items) and the Caregiving Distress Scale., To demonstrate for the total study population (all 3 neurodegenerative diseases) superiority with regards to improving a patient-reported outcome measure evaluated through the Patient Global Impression of Change (PGIC) compared to placebo., To demonstrate in the subpopulation of patients with Alzheimer’s disease (AD) superiority with regards to improvements on specific clinical disease marker functional disability using the standardized Mini Mental Status Examination (MMSE) to evaluate the cognitive functions and the Neuropsychiatric Inventory-agitation subscale for agitation in AD., To demonstrate in the subpopulation of patients with Amyotrophic Lateral Sclerosis superiority with regards to improvement | — |
Countries
Italy
Outcome results
None listed