Study on Cannabis Extract for Improving Quality of Life in Patients with Alzheimer’s, Parkinson’s, or ALS Using Dronabinol and Cannabidiol

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with neurodegenerative diseases, specifically Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease (AD), and Parkinson’s Disease (PD). The treatment being tested is a balanced extract of THC and CBD, known as the Cannabis Extract Avextra 10/10 Solution. The purpose of the study is to determine if this cannabis extract can safely and effectively improve the quality of life for patients with these conditions.

Participants in the study will receive either the cannabis extract or a placebo. The study will be conducted over a period of time, during which participants will take the treatment as an oral solution. The study aims to assess the safety and tolerability of the cannabis extract, as well as its impact on the quality of life, which will be measured using a health survey. Additionally, the study will look at how the treatment affects caregiver distress and patient-reported outcomes.

The study will also explore specific improvements in each disease group. For Alzheimer’s Disease, it will assess cognitive functions and agitation. For Amyotrophic Lateral Sclerosis, it will evaluate functional status. For Parkinson’s Disease, it will monitor the progression of symptoms. The results will help determine if the cannabis extract is a beneficial treatment option for these neurodegenerative diseases.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to age, diagnosis, and current treatments for neurodegenerative diseases such as Alzheimer’s, Parkinson’s, or Amyotrophic Lateral Sclerosis.

Written informed consent is required, either personally or through a legally authorized representative.

2 initial assessment

An initial assessment is conducted to establish baseline health status. This includes evaluations using various scales and surveys to measure quality of life, cognitive functions, and disease-specific symptoms.

3 treatment phase

Participants receive either the cannabis extract Avextra 10/10 oral solution or a placebo. The solution contains a balanced mixture of THC and CBD.

The medication is administered orally, with the dosage and frequency determined by the study protocol. The duration of this phase is specified in the study timeline.

4 ongoing monitoring

Regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes tracking any adverse events and evaluating the impact on quality of life.

Participants may be required to complete surveys and undergo medical evaluations at scheduled intervals.

5 final assessment

At the end of the treatment phase, a final assessment is conducted to evaluate the overall impact of the treatment on quality of life and disease symptoms.

The results are compared to the initial assessment to determine any improvements or changes.

6 study conclusion

The study concludes with a review of all collected data to assess the effectiveness and safety of the treatment.

Participants are informed of the study’s findings and any potential next steps in their care.

Who Can Join the Study?

Patients must be able to give written permission to participate, either by themselves or through a legal representative.
Patients must be older than 55 years.
For patients with Alzheimer’s Disease (AD):
- Must have been diagnosed with AD based on specific criteria for major memory and thinking problems.
- Must have a score of 24 or less on a test called MMSE, which checks memory and thinking skills.
- Must show significant restlessness or agitation.
- If taking medications to help with memory, the dose must not have changed for at least 3 months. If these medications were stopped, they can join after one month.
For patients with Amyotrophic Lateral Sclerosis (ALS):
- Must have a confirmed or likely diagnosis according to specific criteria.
- Must show disease progression in the last three months, measured by a decrease of at least one point on a specific scale.
- Must have a lung function test result of 60% or more of what is expected.
- Must have been taking a medication called riluzole at a dose of 50 mg twice a day for at least one month before the study starts.
For patients with Parkinson’s Disease (PD):
- Must have a diagnosis of Parkinson’s disease with no known cause.
- Must be in stages 1 to 4 of the disease, according to a specific scale.
- Must be able to walk more than 10 meters without help.
- Must be taking a medication called L-Dopa with a stable dose for at least 30 days.

Who Cannot Join the Study?

Patients who do not have a neurodegenerative disease. These are diseases that affect the brain and nerves, such as Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease (AD), and Parkinson’s Disease (PD).
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.05.2024

Trial locations

Investigated drugs:

Avextra 10/10: This is a balanced cannabis extract containing equal parts of THC (tetrahydrocannabinol) and CBD (cannabidiol). It is used in this clinical trial to determine if it can improve the quality of life for patients with neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease, and Amyotrophic Lateral Sclerosis (ALS). The trial aims to assess whether this extract is safe and effective in enhancing the overall well-being of patients by comparing it to a placebo.

Investigated diseases:

Amyotrophic Lateral Sclerosis (ALS) – ALS is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. It leads to the gradual degeneration and death of motor neurons, which are responsible for controlling voluntary muscles. As these neurons die, the brain loses the ability to initiate and control muscle movement, leading to muscle weakness and atrophy. Over time, individuals with ALS may experience difficulty speaking, swallowing, and breathing. The progression of symptoms varies among individuals, but it generally leads to increasing disability.

Alzheimer’s Disease (AD) – Alzheimer’s Disease is a progressive neurological disorder that causes brain cells to degenerate and die, leading to a continuous decline in thinking, behavioral, and social skills. It is characterized by memory loss, confusion, and changes in behavior and personality. As the disease progresses, individuals may have difficulty recognizing family and friends, experience disorientation, and have trouble with language and reasoning. The progression of Alzheimer’s Disease can vary, but it typically leads to severe cognitive impairment and loss of independence.

Parkinson’s Disease (PD) – Parkinson’s Disease is a progressive nervous system disorder that affects movement. It develops gradually, often starting with a barely noticeable tremor in one hand. The disease is characterized by tremors, stiffness, and slowing of movement. As it progresses, individuals may experience difficulty with balance, coordination, and speech. The symptoms of Parkinson’s Disease worsen over time, affecting daily activities and quality of life.

Trial ID:

2023-507715-35-02

Protocol code:

NEUROBIS

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Cannabis Extract for Improving Quality of Life in Patients with Alzheimer’s, Parkinson’s, or ALS Using Dronabinol and Cannabidiol

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