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Nabilone for Agitation in Alzheimer's Disease (NAB-IT Trial)
NAB-IT Trial Summary
This trial will help to determine whether nabilone is an effective treatment for agitation in Alzheimer's disease patients.
NAB-IT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNAB-IT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.NAB-IT Trial Design
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Who is running the clinical trial?
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- You have used marijuana or other cannabis products for fun in the 3 months before the study starts.I am not allergic to cannabis or its products and do not have drug interactions.I experience severe restlessness as defined by health professionals.My medication for memory or thinking problems has been the same for the last 3 months.I am a man or a post-menopausal woman aged 55 or older.You currently have symptoms that meet the criteria for a major depressive episode according to the DSM 5.I have a history of psychiatric or neurological conditions.Your memory and thinking test score is 24 or lower.You have strong beliefs or see things that are not real and it affects your daily life.You have a history of using or being dependent on marijuana.I have been diagnosed with major memory or thinking problems due to Alzheimer's disease.I have a caregiver who can join me for study visits and is fluent in English.I haven't changed my mental health medications in the last week.I do not have any uncontrolled heart problems.My doctor has diagnosed me with a serious liver condition.
- Group 1: Nabilone Arm
- Group 2: Placebo Arm
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there other similar studies to the one using Nabilone?
"At the moment, there are six ongoing clinical trials evaluating nabilone. Three of those studies have reached Phase 3. Most research on nabilone is conducted in Toronto, Ontario; however, there are nine total locations running these investigations."
What have been patients' reactions to Nabilone?
"Given that this is a Phase 3 trial with data supporting efficacy and safety, our team has rated the safety of Nabilone as a 3."
Are we looking for more participants in this clinical trial at the moment?
"Yes, this trial is still looking for patients and the most recent information available was published on August 5th, 2022. The study was originally posted on February 1st, 2021."
How many people are eligible to participate in this clinical trial?
"Yes, the information on clinicaltrials.gov suggests that this trial is actively recruiting participants. The clinical trial was initially posted on 2/1/2021 and was most recently updated on 8/5/2022. The trial is recruiting for 112 participants across 5 sites."
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