Cannabidiol solution for treating anxiety and agitation in older adults with cognitive impairment or Alzheimer's
Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
This study is testing if a special CBD solution can help older adults with mild cognitive impairment or Alzheimer's feel less anxious and agitated.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 55 Years to 90 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT04075435 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a high CBD/low THC sublingual solution in reducing anxiety and agitation in older adults diagnosed with mild cognitive impairment or mild to moderate Alzheimer's Disease. The trial is open-label and spans eight weeks, focusing on participants who exhibit clinically significant anxiety. Eligible participants must have a specific MMSE score and a caregiver who can attend study visits. The study aims to assess safety and efficacy in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 55-90 with a diagnosis of mild cognitive impairment or mild to moderate Alzheimer's Disease who experience clinically significant anxiety.
Not a fit: Patients with serious medical illnesses, seizure disorders, or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate anxiety and agitation symptoms in older adults with cognitive impairments, improving their quality of life.
How similar studies have performed: While there is growing interest in the use of cannabinoids for treating symptoms of dementia, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI 2. MMSE score of 15-30 (inclusive) 3. Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C 4. A health care proxy available to sign consent on behalf of the participant (if applicable) 5. A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits 6. Participants and their study partner must be fluent in English 7. Must be 55-90 years old (inclusive) Exclusion Criteria: 1. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes. 2. Seizure disorder 3. Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI 4. Current episode of major depression, as determined by the MINI 5. Active substance abuse or dependence within the past 6 months, as determined by the MINI 6. Delirium (as measured by the CAM) 7. Current inpatient hospitalization 8. Current regular use of cannabinoid products (\>1 use per month) 9. Positive urine screen for THC at the screening or baseline visit 10. Allergy to coconut 11. Participants taking strong inhibitors or inducers of CYP3A4 (e.g. fluconazole, fluoxetine, fluvoxamine, ticlopidine, St. John's Wort, etc.), CYP2C19 (ketoconazole, erythromycin, etc.), or anti-epileptic drugs
Where this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Staci Gruber, PhD — Mclean Hospital
- Study coordinator: Emily H Kim, BS
- Email: ekim76@mgb.org
- Phone: 617-855-2562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.