2023-507715-35-02RecruitingPhase 2
MEDICAL CANNABIS TREATMENT IN NEURODEGENERATIVE DISEASES (NEUROBIS)
MEDICAL CANNABIS FOR NEURODEGENERATIVE DISEASES: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II CLINICAL TRIAL (NEUROBIS)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 186 (estimated)
- First submitted
- 23 Apr 2024
- Start date
- 30 Sept 2024
- Lead sponsor
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Diseases
- ALS (motor neurone disease)
- EU CT number
- 2023-507715-35-02
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 186
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people over 55 with Alzheimer's disease, Parkinson's disease or ALS. It tests a cannabis extract against placebo for quality of life.
- Age
- Over 55 years (the registry lists a minimum age of 18 years).
- Sex
- All sexes can join.
- Disease stage
- Alzheimer's disease: MMSE 24 or lower and clearly significant agitation. ALS: definite or probable ALS with disease progression in the last three months and FVC 60% or higher. Parkinson's disease: idiopathic, modified Hoehn and Yahr stage 1 to 4, able to walk more than 10 metres without aids.
- Earlier treatment
- Alzheimer's: cognitive-enhancing medicines (if used) at a stable dose for at least 3 months. ALS: riluzole 50 mg twice a day for at least one month. Parkinson's: L-Dopa at a stable dose for at least 30 days.
Main reasons for not taking part
- Significant heart disease
- Pregnancy or breastfeeding
- Serious kidney or liver failure
- Other psychiatric or neurological conditions, or alcohol or drug abuse
- Current use of cannabinoids or allergy to any cannabinoid
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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).
Lab values
- 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.
Other
- Clinically significant delusions and/or hallucinations.
- Pregnancy and breastfeeding.
- Inability to provide inform consent.
- Orthostatic hypotension.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | Recruiting |
| Sant'Andrea Hospital, ASL VC | - | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.