BridgeMD
New treatment option for Mild Cognitive Impairment
Official title CBD for Individuals at Risk for Alzheimer's Disease
ClinicalTrials.gov ID: NCT05822362
What this study is testing
What is Cannabidiol?
Cannabidiol is an investigational medicine, being studied as a potential treatment for mild cognitive impairment.
Also referred to as CBD.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 85
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.
See the full eligibility criteria
- 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...
- 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).
- 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
- 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...
- Participation in other clinical studies involving neuropsychological measures being collected more than one time per year.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.