RESEARCH / PARTICIPATIONBack to the library
← Find a study
Recruiting · registry status

A cannabis extract for neurological conditions

Researchers are testing an oral extract containing THC and CBD and measuring safety and quality of life.

Testing a treatment or activity · Study reference: 2023-507715-35-02

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

Follow this study

Looking for volunteers

Start (planned)
2024-05-01
Study finished (planned)
2027-05-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age range not listed · Ask the team who can join

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: Not reported

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 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).
Full study name & original research details

Official study title

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

Short title used by the registry

MEDICAL CANNABIS TREATMENT IN NEURODEGENERATIVE DISEASES (NEUROBIS)

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). 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.

Conditions reported: Patients suffering from neurodegenerative diseases: Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease (AD) and Parkinson’s Disease (PD).

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Mixture of Sesame oil / Linseed oil (9:1), Cannabis Extract Avextra 10/10 Solution
Phases
Therapeutic exploratory (Phase II)
Sponsor
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Start date reported by registry
2024-05-01 (estimated)

Registry updated: 2024-07-17 · Status last verified by the registry submitter: Not reported

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Letizia Mazzini · +3903213733834 · letizia.mazzini@uniupo.it

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Novara, Italy

Recruiting

Sant'Andrea Hospital, ASL VC

Italy

Recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.