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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3, 6, 9, and 12 of the optional follow-up phase for reporting.

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 more

Other 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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met