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Cannabinoid
Cannabidiol Solution for Alzheimer's Disease (CBD Trial)
Phase < 1
Recruiting
Led By Brent P Forester, MD, MSc
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)
Must not have
Seizure disorder
Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 3, 6, 9, and 12 of the optional follow-up phase
Awards & highlights
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.
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.
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.
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.
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I am between 60 and 90 years old.
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I have a caregiver who can attend all study visits with me.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a seizure disorder.
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I do not have any serious illnesses that could affect the study's safety assessment.
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I have been diagnosed with major depression recently.
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I am not taking any strong medication that affects liver enzymes.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total of clinician impression column on anxiety domain of the NPI-C
Secondary study objectives
Number and severity of side effects reported
Number of serious adverse events
Score on the confusion assessment method
+2 moreOther study objectives
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 moreTrial 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
215 Previous Clinical Trials
21,681 Total Patients Enrolled
Brent P Forester, MD, MScPrincipal InvestigatorMclean Hospital
1 Previous Clinical Trials
50 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.
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