Alzheimer DiseaseEarly Phase 1CBDNCT04075435
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
A Early Phase 1 study testing high CBD/low THC sublingual solution in people with Alzheimer Disease and Anxiety, run by Mclean Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease, Anxiety, Agitation,Psychomotor
- What is being tested?
- high CBD/low THC sublingual solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 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).
- Conditions
- Alzheimer Disease, Anxiety, Agitation,Psychomotor, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
- Being tested
- high CBD/low THC sublingual solution
- Keywords
- cannabidiol, older adults, dementia
- Medical subject headings
- Alzheimer Disease, Anxiety Disorders, Psychomotor Agitation, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high CBD/low THC sublingual solutionDrug
Hemp derived solution to be administered sublingually twice daily.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | 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. Receives: Drug: high CBD/low THC sublingual solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total of clinician impression column on anxiety domain of the NPI-C
Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
Measured: Continuous, weeks 0-8
Secondary outcomes (5)
Total score on the Generalized Anxiety Disorder 7 scale
Secondary Outcome Measure of anxiety reduction
Measured: Continuous, week 0-8
Number of serious adverse events
Secondary Outcome Measure of safety defined by absence of serious adverse events
Measured: Continuous, weeks 0-8
Week 8 MMSE total score compared to baseline MMSE total score
Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)
Measured: longitudinal: screening/baseline and week8
Score on the confusion assessment method
Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)
Measured: Continuous screening weeks 0-8, dichotomous
Number and severity of side effects reported
Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire
Measured: Continuous, weeks 0-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start11 Jan 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label trial; all participants will receive active drug.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Spier Family Foundation
- Responsible party
- Principal investigator, Staci Gruber, Ph.D., Mclean Hospital
- Investigators
- Staci Gruber, PhD, Principal investigator, Mclean HospitalIpsit V Vahia, MD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075435
- Sponsor's protocol ID
- 2019P002466
- Acronym
- CBD
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2019
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT04075435
- Acronym / sponsor ID
- CBD / 2019P002466
- Conditions
- Alzheimer Disease, Anxiety, Agitation,Psychomotor, Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
- Keywords
- cannabidiol, older adults, dementia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Spier Family Foundation
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label trial; all participants will receive active drug.
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Drug: high CBD/low THC sublingual solutionThis arm will include all subjects, individuals will administer a high CBD, low THC full spectrum sublingual solution twice daily on a variable dosing schedule. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high CBD/low THC sublingual solutionHemp derived solution to be administered sublingually twice daily. | Drug | All subjects |
Primary outcome
Total of clinician impression column on anxiety domain of the NPI-C
Time frame: Continuous, weeks 0-8
Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale
5 secondary outcomes
Total score on the Generalized Anxiety Disorder 7 scale
Time frame: Continuous, week 0-8
Number of serious adverse events
Time frame: Continuous, weeks 0-8
Week 8 MMSE total score compared to baseline MMSE total score
Time frame: longitudinal: screening/baseline and week8
Score on the confusion assessment method
Time frame: Continuous screening weeks 0-8, dichotomous
Number and severity of side effects reported
Time frame: Continuous, weeks 0-8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Staci Gruber, PhD principal investigator
Mclean Hospital
Ipsit V Vahia, MD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing high CBD/low THC sublingual solution in people with Alzheimer Disease and Anxiety, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total of clinician impression column on anxiety domain of the NPI-C (time frame: Continuous, weeks 0-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.