CBD for Alzheimer's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether cannabidiol (CBD) can slow the progression of Alzheimer's disease and improve cognitive and behavioral functions. Participants will take different types of CBD or a placebo (a non-active substance) to compare effects. Individuals diagnosed with Mild Cognitive Impairment, who can still perform daily tasks independently, might be suitable candidates. The trial aims to determine if CBD positively impacts key markers of Alzheimer's and daily cognitive abilities. Participants must live in the Denver area and attend in-person visits. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, including Parkinson's medications, antipsychotic medications, anti-seizure medications, anticholinergic medications, and any medications that are contraindicated with Epidiolex. If you are taking any of these, you would need to stop before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cannabidiol (CBD) has been studied for its effects on Alzheimer's disease, particularly in animals. In these studies, CBD demonstrated potential benefits, such as reducing memory problems and improving social interactions in animals with symptoms similar to Alzheimer's.
Regarding safety in humans, CBD is generally well-tolerated. Studies indicate that most people experience only mild side effects, such as fatigue or changes in appetite. This trial tests both full-spectrum and broad-spectrum CBD, which have similar safety profiles. Full-spectrum CBD contains a tiny amount of THC (less than 0.3%), while broad-spectrum CBD has no THC.
As a Phase 2 trial, the treatment has already passed initial safety tests, providing some evidence of its safety for humans. However, more data will help confirm this. Overall, CBD's use in earlier trials and its approval for other conditions suggest it is relatively safe, but monitoring during the trial will ensure any potential side effects are managed.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using cannabidiol (CBD) for Alzheimer's disease because it offers a potential alternative mechanism to current treatments. Unlike standard medications that primarily focus on managing symptoms by altering neurotransmitter activity, CBD targets inflammation and oxidative stress, which are believed to play a role in Alzheimer's progression. Full-spectrum CBD contains a variety of cannabinoids, potentially enhancing its therapeutic effects, while broad-spectrum CBD excludes THC, eliminating any psychoactive effects. This approach could provide a more holistic way to address the underlying causes of Alzheimer's, offering hope for improved outcomes.
What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?
This trial will compare different formulations of cannabidiol (CBD) for Alzheimer's disease. Research suggests that CBD might help with this condition. Studies have shown that CBD can improve memory and reduce anxiety in animals. It also helps lower inflammation, which plays a crucial role in Alzheimer's. CBD affects genes linked to the disease and may protect brain cells from damage. These findings are promising, but more research in humans is needed to confirm its effectiveness. Participants in this trial may receive full-spectrum CBD, broad-spectrum CBD, or a placebo (hemp seed oil) to evaluate the effectiveness of these treatments.25678
Are You a Good Fit for This Trial?
This trial is for individuals aged 55-85 who have been diagnosed with Mild Cognitive Impairment (MCI) at the University of Colorado School of Medicine. They must show specific signs of cognitive decline but not full-blown dementia, as indicated by a score of .5 on the Clinical Dementia Rating scale.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Full Spectrum CBD, Broad Spectrum CBD, or placebo for 24 weeks to assess effects on Alzheimer's disease progression and other health measures
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol
- Placebo
Cannabidiol is already approved in United States, European Union, Canada for the following indications:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor