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Cannabinoid
Cannabidiol Solution for Alzheimer's Disease (CBD Trial)
Phase < 1
Recruiting
Led By Ipsit V Vahia, MD
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al.
Must be 60-90 years old (inclusive)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3, 6, 9, and 12 of the optional follow-up phase
Awards & highlights
CBD Trial Summary
This trial is testing a CBD/THC solution to see if it can help with anxiety and agitation in Alzheimer's patients.
Who is the study for?
This trial is for older adults aged 60-90 with mild to moderate Alzheimer's Dementia, experiencing significant anxiety. Participants must have a caregiver, an MMSE score of 15-24, and be fluent in English. Those with recent substance abuse, certain medication use, severe allergies (like coconut), or major psychiatric disorders other than Alzheimer's are excluded.Check my eligibility
What is being tested?
The study tests a high CBD/low THC sublingual solution over eight weeks to see if it reduces anxiety and agitation in Alzheimer's patients. It’s an open label trial meaning everyone knows they're getting the actual treatment without any placebo comparison.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of CBD may include drowsiness, dry mouth, lowered blood pressure, light headedness and potential liver injury. THC can cause altered senses/time perception/mood changes.
CBD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Alzheimer's based on specific criteria.
Select...
I am between 60 and 90 years old.
Select...
I have a caregiver who can attend all study visits with me.
CBD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 3, 6, 9, and 12 of the optional follow-up phase
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 3, 6, 9, and 12 of the optional follow-up phase
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total of clinician impression column on anxiety domain of the NPI-C
Secondary outcome measures
Number and severity of side effects reported
Number of serious adverse events
Score on the confusion assessment method
+2 moreOther outcome measures
Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7
Stability of caregiver burden reduction
Total Score of Zarit Caregiver Burden Interview
+2 moreCBD Trial Design
1Treatment groups
Experimental Treatment
Group I: All subjectsExperimental Treatment1 Intervention
This arm will include all subjects, individuals will administer a high CBD, low THC full spectrum sublingual solution twice daily on a variable dosing schedule.
Find a Location
Who is running the clinical trial?
Spier Family FoundationUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
Mclean HospitalLead Sponsor
213 Previous Clinical Trials
21,682 Total Patients Enrolled
Ipsit V Vahia, MDPrincipal InvestigatorMclean Hospital
1 Previous Clinical Trials
89 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a seizure disorder.You have been diagnosed with bipolar disorder, schizophrenia, or schizoaffective disorder at any time in your life.You are currently using cannabinoid products regularly, at least once a month.I have been diagnosed with Alzheimer's based on specific criteria.You have a high level of anxiety, as determined by a specific test score.I am between 60 and 90 years old.I have a caregiver who can attend all study visits with me.I do not have any serious illnesses that could affect the study's safety assessment.I have been diagnosed with major depression recently.You have tested positive for THC in your urine at the screening or baseline visit.You have been using drugs or alcohol excessively in the past 6 months.I am not taking any strong medication that affects liver enzymes.You are allergic to coconut.You scored between 15 and 24 on a memory and thinking test.You have signs of confusion and disorientation, as measured by a specific test called the CAM.
Research Study Groups:
This trial has the following groups:- Group 1: All subjects
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide a summary of previous research conducted on this specific treatment?
"Presently, there are 16 Phase 3 trials and 79 total trials underway for this medication. The largest concentration of these studies is in Ribeirao Preto, Sao Paulo; however, investigations into its efficacy occur across 290 different sites globally."
Answered by AI
How many participants have enrolled in this research endeavor thus far?
"Affirmative. The information provided on clinicaltrials.gov reveals that this medical trial is presently enrolling participants, having been first posted in January 11th 2021 and most recently modified April 4th 2022. This study requires 12 individuals from one location to complete the experiment."
Answered by AI
Is it possible to be enrolled in this medical experiment?
"This clinical trial seeks individuals with Alzheimer's disease who are between the ages of 60 and 90. The medical team is seeking to admit 12 participants in total."
Answered by AI
Is there an opportunity for new participants to join this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical investigation is presently enrolling candidates; it was initially listed on November 1st 2021 and the listing has been revised most recently as of April 4th 2022. The study necessitates 12 participants from a single site for completion."
Answered by AI
Are individuals aged 45 and older eligible for this experiment?
"For this clinical trial, individuals aged between 60 and 90 years are eligible for participation."
Answered by AI
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