NCT04075435Active, not recruitingEarly phase 1
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 29 Aug 2019
- Start date
- 11 Jan 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Mclean Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT04075435
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 12
- From 11 Jan 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
- Allergy to coconut
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 55 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.