AzTrials
AzTrials

Mild Cognitive ImpairmentPhase 2NCT05822362

CBD for Individuals at Risk for Alzheimer's Disease

A Phase 2 study testing Cannabidiol in people with Mild Cognitive Impairment, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a double-blind, randomized controlled trial designed to test the effects of cannabidiol (CBD) on validated biomarkers of Alzheimer's disease (AD) progression, and behavioral, neurocognitive, and clinical measures, with putative mechanisms of action. Read more about this study

Who is it for?
Ages 55 to 85 years
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
Cannabidiol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
236 participants
Where
1 siteUnited States
Study dates
19 Jan 2024to Apr 2029
Phase
Phase 2
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be between the ages of 55 - 85 and provide valid informed consent.
  • 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.
  • Functional Activities Questionnaire (FAQ) score of 8 or less and self-reported ability to function independently.
  • Montreal Cognitive Assessment (MoCa) score is ≤ 25
  • 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.
  • 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).
Show all 10Show fewer
  • Participant must pass a test of consent comprehension
  • Must be interested in using CBD to help with cognitive function
  • Must plan on living in the Denver metro area over the next 6 months
  • Able to attend in-person visits at the study site

Who cannot join

  • Any other central nervous system (CNS) disease that would be expected to affect cognition, Parkinson's disease, multiple sclerosis.
  • History of brain injury resulting in current memory loss symptoms (e.g., concussion with significant loss of consciousness)
  • Any significant systemic illness or unstable medical condition
  • Current use of Parkinson's medications, antipsychotic medications, anti-seizure medications, or anticholinergic medications
  • 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
  • Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.
Show all 15Show fewer
  • 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.
  • Report using more than 150mg of cannabis edible products per week.
  • Report using more than 7 grams of cannabis flower product (not including CBD) per week.
  • Recent history of, or meets criteria for major depression with suicidal ideation.
  • Reports use of medical CBD.
  • Liver function enzymes (AST, ALT) that are greater than 2x normal.
  • Currently taking medications known to be contraindicated with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).
  • Pregnant at the time of study enrollment or unwilling to use contraception through the duration of the study (if not yet post-menopausal)
  • Individuals with potentially reversible causes of mild cognitive impairment (i.e., hypothyroidism, Vitamin B12 deficiency).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Raeghan Mueller, PhD contact

3037242210

raeghan.mueller@cuanschutz.edu

United States1 site, 1 recruiting

  • University of Colorado - Anschutz Medical Campus

    Aurora, Colorado, 80045

    Raeghan Mueller, PhD, raeghan.mueller@cuanschutz.edu

    Mariah N Brown, MPH, mariah.n.brown@cuanschutz.edu

    Recruiting

Other trials in United States

About this study

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

This is a double-blind, randomized controlled trial designed to test the effects of cannabidiol (CBD) on validated biomarkers of Alzheimer's disease (AD) progression, and behavioral, neurocognitive, and clinical measures, with putative mechanisms of action.

Read the detailed description

To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of individuals diagnosed with mild cognitive impairment (MCI).

This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, on biomarkers of Alzheimer's disease progression, cognitive function, pain, sleep quality, anxiety, oxidative stress, and inflammation. If eligible for the study, subjects will be randomized to receive one of the conditions for 24 weeks.

The current study will test the hypothesis that a moderate dose of CBD will improve measures of Alzheimer's disease progression, cognitive function, pain, sleep quality, anxiety, oxidative stress, and inflammation as compared to placebo. The study will also test whether endocannabinoids mediate the effects of CBD on these outcomes.

Being tested
Cannabidiol, Placebo
Keywords
Cognition, Cannabidiol, Aging, Memory, Alzheimer's Disease, CBD, MCI, Mild Cognitive Impairment, Cognitive decline, Healthy aging, Older adults, Brain, Cannabis, Marijuana
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabidiolDrug

    Also called CBD

    The current study will directly test the hypothesis that a moderate dose of CBD improves markers of Alzheimer's progression, cognitive function, sleep, pain, anxiety, oxidative stress, and inflammation.

  • PlaceboOther

    Placebo arm.

Study groups in NCT05822362
Study groupRoleWhat they receive
Full Spectrum CannabidiolActive comparator200mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
Receives: Drug: Cannabidiol
Broad Spectrum CannabidiolActive comparator200mg/day of broad-spectrum cannabidiol, containing 0.0% THC.
Receives: Drug: Cannabidiol
Hemp Seed OilPlacebo comparator200mg/day of hemp seed oil with no cannabinoids present.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurocognitive Function

    The following assessments will be used to inform an aggregate measure of neurocognitive function:

    • The Clinical Dementia Rating Scale is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias. Higher scores indicate worse cognitive impairment.
    • NIH-Toolbox Cognitive Battery (NIH-TB CB) assessments are used to detect and measure specific aspects of cognition, including crystallized intelligence, psychomotor function, executive function, attention, and working memory.
    • Rey Auditory Verbal Learning Test to evaluate working memory and the Digit Symbol Substitution Task to evaluate global cognitive operations.
    • Montreal Cognitive Assessment (MoCa)
    • Functional Activities Questionnaire (FAQ) will be used to measure changes in dementia risk over the course of the clinical trial.

    Measured: Week 0 to Week 24

  2. Biomarkers of Alzheimer's Disease Progression

    • Changes in plasma levels of N-p-tau181 will be measured in ng/dl.
    • Changes in plasma Aβ42/Aβ40 ratio will be measured in ng/dl.
    • Changes in plasma Neurofilament Light (Nfl) will be measured in ng/dl.

    Measured: Week 0 to Week 24

Secondary outcomes (4)

  1. Change in pain

    • The PROMIS Pain Intensity 1a questionnaire consists of two items asking about the participant's level of pain on average and at its worst in the past 7 days. Participants are asked to rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain).
    • The PROMIS Short Form v1.1 - Pain Interference - 6b scale will be used to assess how disruptive pain was over the past 7 days. There are six questions with a total score of 30-higher scores indicate more interference.

    Measured: Week 0 to Week 24

  2. Change in sleep

    • The PROMIS Sleep Disturbance 4a assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Scores range from 4-20, with higher scores indicating worse sleep outcomes.
    • The PROMIS Sleep-Related Impairment 4a assesses perceptions of alertness, sleepiness, tiredness, and perceived functional impairments during usual waking hours due to sleep problems. Scores range from 4-20, with higher scores indicating worse sleep-related impairment.
    • The PROMIS Short Form v1.0 - Fatigue 4a measures subject fatigue over the past 7 days. Scores range from 4-20, with higher scores indicating more fatigue.

    Measured: Week 0 to Week 24

  3. Change in anxiety

    -The Depression Anxiety Stress Scale is a 21-item self-report instrument for measuring the three related negative emotional states of depression, anxiety, and tension/stress. Higher scores indicate worse anxiety

    Measured: Week 0 to Week 24

  4. Change in plasma lipid biomarkers of inflammation and oxidative stress

    Change in plasma levels of 5-iso PGF2αVI, 16-HETE, PGD2 will be measured in ng/dl.

    Measured: Week 0 to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2023
  2. Study start19 Jan 2024
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a double-blind, placebo-controlled, parallel group study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822362
Sponsor's protocol ID
23-0619
Status last verified
Jun 2026
First submitted
7 Apr 2023
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabidiol in people with Mild Cognitive Impairment, run by University of Colorado, Denver 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 10 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 15 Jun 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. Some participants in this study may receive a placebo. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Raeghan Mueller, PhD (3037242210, raeghan.mueller@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurocognitive Function (time frame: Week 0 to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822362.

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 15 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in