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RecruitingPhase 2

CBD for Individuals at Risk for Alzheimer's Disease

Cannabidiol for Individuals at Risk for Alzheimer's Disease: A Randomized Placebo Controlled Trial

Asset

Cannabidiol

Listed sites

1

Recruiting sites

1

Enrollment

236

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

MoCA ≤25

Primary endpoints

Montreal Cognitive Assessment (MoCA)Phosphorylated tau 181 (p-tau181)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID23-0619
NCT IDNCT05822362

Timeline

Milestones

Study first posted2023-04-20actual
Study start2024-01-19actual
Last update posted2026-06-15actual
Primary completion2028-04estimated (month precision)
Study completion2029-04estimated (month precision)

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Must be between the ages of 55 - 85 and provide valid informed consent.

2. Participant must receive a diagnosis of Mild Cognitive Impairment after a careful cognitive and functional evaluation by a clinician, or have symptoms of Mild Cognitive Impairment as determined by the study physician.

3. Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.

4. Montreal Cognitive Assessment (MoCa) score is ≤ 25

5. Participant must have a CDR score of .5 or 1 on the Clinical Dementia Rating scale (CDR), which includes an assessment of function and is often used to distinguish MCI from dementia. A score of 0.5 indicates mild cognitive impairment but not dementia and a score of 1 indicates mild-to-moderate cognitive impairment.

6. Must have an informant that will be utilized over the course of the 24 week study (must be the same person for all CDR assessments completed via phone).

7. Participant must pass a test of consent comprehension

8. Must be interested in using CBD to help with cognitive function

9. Must plan on living in the Denver metro area over the next 6 months

10. Able to attend in-person visits at the study site

Exclusion criteria

1. Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.

2. History of brain injury resulting in current memory loss symptoms (e.g., concussion with significant loss of consciousness)

3. Any significant systemic illness or unstable medical condition

4. Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications

5. Current or lifetime diagnosis of a schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by the DSM-5-TR

6. Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.

7. Reported use of other drugs (cocaine, opiates, methamphetamine, MDMA) in the past 60 days or test positive on a urine test for those drugs of abuse at baseline.

8. Report using more than 150mg of cannabis edible products per week.

9. Report using more than 7 grams of cannabis flower product (not including CBD) per week.

10. Recent history of, or meets criteria for major depression with suicidal ideation.

11. Reports use of medical CBD.

12. Liver function enzymes (AST, ALT) that are greater than 2x normal.

13. Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).

14. Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)

15. Individuals with potentially reversible causes of mild cognitive impairment (i.e., hypothyroidism, Vitamin B12 deficiency).

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
2
Other (unclassified)
2
Global cognition
1
Disease progression
1

Global cognition

1 endpoint
Primary/protocol endpoint

Neurocognitive Function

Time frame:Week 0 to Week 24

Montreal Cognitive Assessment (MoCA)

ratio, descriptive

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Change in sleep

Time frame:Week 0 to Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in anxiety

Time frame:Week 0 to Week 24

change from baseline, improvement

Disease progression

1 endpoint
Primary/protocol endpoint

Biomarkers of Alzheimer's Disease Progression

Time frame:Week 0 to Week 24

Phosphorylated tau 181 (p-tau181)

ratio, descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change in pain

Time frame:Week 0 to Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in plasma lipid biomarkers of inflammation and oxidative stress

Time frame:Week 0 to Week 24

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.