NCT04075435 · Early Phase 1 · ACTIVE NOT RECRUITING
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
This trial tests a cannabis-derived mouth solution, high in CBD and low in THC, in people with mild cognitive impairment or mild to moderate Alzheimer's. It measures whether anxiety and agitation improve over eight weeks. Everyone gets the real product. It is an early Phase 1 study, meaning a first look at safety and early signals, not proven or approved.
You may qualify if
- Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI
- MMSE score of 15-30 (inclusive)
- Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C
- A health care proxy available to sign consent on behalf of the participant (if applicable)
- A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits
- Participants and their study partner must be fluent in English
- Must be 55-90 years old (inclusive)
You're excluded if
- Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
- Seizure disorder
- Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI
- Current episode of major depression, as determined by the MINI
- Active substance abuse or dependence within the past 6 months, as determined by the MINI
- Delirium (as measured by the CAM)
- Current inpatient hospitalization
- Current regular use of cannabinoid products (>1 use per month)
- Positive urine screen for THC at the screening or baseline visit
- Allergy to coconut
- 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-30