CBD for Alzheimer's Disease

Overseen By Raeghan Mueller, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must not be taking: Parkinson's, Antipsychotics, Anti-seizure, Anticholinergics

Disqualifiers: CNS diseases, Brain injury, Schizophrenia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

236 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug CBD for Alzheimer's Disease?

Research shows that CBD, a component of cannabis, can reduce brain inflammation and protect brain cells in animal models of Alzheimer's Disease. It has also been found to improve memory and cognitive function in these models, suggesting potential benefits for Alzheimer's patients. ^{1 2 3 4 5}

Is CBD safe for humans?

CBD is generally considered safe for humans, as it is a non-psychoactive compound with neuroprotective and anti-inflammatory properties. It has been used in various studies for conditions like epilepsy and Alzheimer's disease, showing potential benefits without significant safety concerns. ^{1 2 4 6 7}

How does the drug CBD differ from other treatments for Alzheimer's disease?

CBD is unique because it is a non-psychoactive compound from cannabis that offers neuroprotective, anti-inflammatory, and antioxidant benefits, potentially reversing cognitive deficits and reducing harmful brain changes in Alzheimer's, unlike current treatments that only provide limited symptom relief. ^{1 2 6 8 9}

What is the purpose of this 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.

Eligibility Criteria

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

I can go to the study site for visits.

I have someone who can provide information about me during the 24-week study.

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

Exclusion Criteria

I use medical CBD.

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

I have used drugs like cocaine or opiates in the last 60 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabidiol
• Placebo

Trial Overview The study is testing whether cannabidiol (CBD), a compound found in cannabis plants, can slow down or affect Alzheimer's disease progression compared to a placebo. Participants won't know if they're getting CBD or the placebo in this double-blind study.

Participant Groups

Group I: Full Spectrum Cannabidiol Active Control 1 Intervention

200mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.

Group II: Broad Spectrum Cannabidiol Active Control 1 Intervention

200mg/day of broad-spectrum cannabidiol, containing 0.0% THC.

Group III: Hemp Seed Oil Placebo Group 1 Intervention

200mg/day of hemp seed oil with no cannabinoids present.

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

Cannabidiol (CBD) shows promise as a potential treatment for Alzheimer's disease (AD) by reducing neuroinflammation, promoting neurogenesis, and reversing cognitive deficits in animal models, indicating its neuroprotective properties.

Combination therapies of CBD with Δ9-tetrahydrocannabinol (THC) may enhance therapeutic benefits while mitigating THC's psychoactive effects, suggesting a multifaceted approach to AD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo Evidence for Therapeutic Properties of Cannabidiol (CBD) for Alzheimer's Disease. Watt, G., Karl, T.[2020]

Cannabidiol (CBD) has shown potential in reversing cognitive deficits and reducing neuroinflammation and neuronal death in Alzheimer's disease (AD) models, indicating its neuroprotective effects.

CBD may help delay the progression of AD by decreasing the accumulation of amyloid beta and hyperphosphorylated tau, suggesting it could be a promising therapeutic option beyond current treatments that only provide symptomatic relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding the Modulatory Effects of Cannabidiol on Alzheimer's Disease. Xiong, Y., Lim, CS.[2021]

The endocannabinoid system is significantly impacted in Alzheimer's disease (AD), and phytocannabinoids like CBD and THC show promise in reversing cognitive deficits and improving cognition in animal models of AD.

Using a multi-cannabinoid approach, such as whole plant extracts or specific CBD:THC combinations, may enhance therapeutic effects compared to using individual cannabinoid isolates, but more clinical studies are needed to optimize treatment strategies and assess side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic properties of multi-cannabinoid treatment strategies for Alzheimer's disease. Coles, M., Steiner-Lim, GZ., Karl, T.[2022]

In a study of 30 Alzheimer's disease patients aged 65-90, the administration of a THC:CBD cannabis extract for 12 weeks significantly reduced symptoms such as agitation, irritability, and sleep disturbances, improving caregiver distress.

The study also found that 45% of patients showed a significant decrease in cognitive impairment, indicating potential efficacy of cannabis extracts in managing severe symptoms of Alzheimer's disease, despite limitations like the small sample size and lack of a control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral THC: CBD cannabis extract in main symptoms of Alzheimer disease: agitation and weight loss. Palmieri, B., Vadalà, M.[2023]

Cannabidiol (CBD) has been shown to protect synaptic plasticity in an in vitro model of Alzheimer's disease by rescuing long-term potentiation (LTP) deficits caused by beta amyloid peptide, indicating its potential therapeutic role in AD.

The neuroprotective effects of CBD do not involve common receptors like 5HT1A, A2A, or CB1, but are mediated through PPARγ, suggesting a unique mechanism of action that could be targeted for Alzheimer's treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Reverses Deficits in Hippocampal LTP in a Model of Alzheimer's Disease. Hughes, B., Herron, CE.[2020]

Cannabidiol (CBD) shows promise in treating Alzheimer's disease by reducing cognitive deficits and protecting neurons from Aβ-induced toxicity, as demonstrated in both in vitro and in vivo studies.

CBD works by modulating microglial activity, promoting the release of neurotrophic factors, and regulating inflammatory genes, suggesting it could be a valuable addition to nutritional guidelines for Alzheimer's disease prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Cannabidiol as a Therapeutic Agent for Preventing and Alleviating Alzheimer's Disease Neurodegeneration. Chen, L., Sun, Y., Li, J., et al.[2023]

In a study involving female APPxPS1 mice, daily treatment with 20 mg/kg of cannabidiol (CBD) for 8 months improved spatial learning and memory, as evidenced by reduced latencies in finding food rewards compared to untreated controls.

CBD treatment did not affect anxiety-like behaviors but did increase locomotion in the APPxPS1 mice, suggesting that CBD may have potential as a preventive therapy for cognitive decline in female Alzheimer's disease models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of long-term cannabidiol on learning and anxiety in a female Alzheimer's disease mouse model. Chesworth, R., Cheng, D., Staub, C., et al.[2022]

Cannabidiol (CBD) is highlighted for its therapeutic potential due to its lack of dependence risk, making it a safer alternative to delta-9-tetrahydrocannabinol (THC), which has mild psychotropic effects and associated restrictions.

The review discusses CBD's pharmacodynamic and pharmacokinetic properties, particularly its beneficial effects on aging and diseases like Alzheimer's, suggesting it may play a role in managing these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Main Therapeutic Applications of Cannabidiol (CBD) and Its Potential Effects on Aging with Respect to Alzheimer's Disease. Trojan, V., Landa, L., Šulcová, A., et al.[2023]

This clinical trial will assess the effects of daily CBD treatment over 12 weeks in 60 participants with early-stage dementia, focusing on neurobiological, behavioral, and psychological outcomes.

The study aims to provide insights into whether CBD can improve quality of life and treatment outcomes for individuals with dementia, marking one of the first investigations into isolated CBD's potential benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a Treatment for Neurobiological, Behavioral, and Psychological Symptoms in Early-Stage Dementia: A Double-Blind, Placebo-Controlled Clinical Trial Protocol. Bartschi, JG., Greenwood, LM., Montgomery, A., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

In vivo Evidence for Therapeutic Properties of Cannabidiol (CBD) for Alzheimer's Disease. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Understanding the Modulatory Effects of Cannabidiol on Alzheimer's Disease. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic properties of multi-cannabinoid treatment strategies for Alzheimer's disease. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Oral THC: CBD cannabis extract in main symptoms of Alzheimer disease: agitation and weight loss. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol Reverses Deficits in Hippocampal LTP in a Model of Alzheimer's Disease. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing Cannabidiol as a Therapeutic Agent for Preventing and Alleviating Alzheimer's Disease Neurodegeneration. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of long-term cannabidiol on learning and anxiety in a female Alzheimer's disease mouse model. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Main Therapeutic Applications of Cannabidiol (CBD) and Its Potential Effects on Aging with Respect to Alzheimer's Disease. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol as a Treatment for Neurobiological, Behavioral, and Psychological Symptoms in Early-Stage Dementia: A Double-Blind, Placebo-Controlled Clinical Trial Protocol. [2023]