CBD + THC for Agitation in Dementia (LiBBY Trial)
Recruiting in Palo Alto (17 mi)
+20 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Southern California
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks.
This study will enroll approximately 150 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo.
The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period.
What data supports the effectiveness of the drug for agitation in dementia?
Research suggests that cannabinoids, including THC and CBD, may help reduce agitation in dementia patients. Studies have shown that these compounds can be effective and safe, with fewer side effects compared to traditional medications used for dementia-related behaviors.
14567Is the combination of CBD and THC safe for treating agitation in dementia?
Studies suggest that using CBD and THC together is generally safe for older people with dementia-related agitation, with few short-term side effects. However, more research is needed to fully understand their safety and effectiveness.
23457How is the drug CBD + THC unique for treating agitation in dementia?
The CBD + THC drug is unique for treating agitation in dementia because it targets the endocannabinoid system, which may help reduce neuroinflammation and enhance brain health, offering a potentially safer alternative to traditional medications that often have more side effects.
23467Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must not use any cannabinoids (like marijuana) during the first 12 weeks of the study.
Eligibility Criteria
This trial is for hospice care-eligible patients aged 40 or older with dementia and significant agitation. They must not use other cannabinoids during the study, be able to take liquid medication, have a caregiver to help with the study requirements, and meet specific clinical criteria.Inclusion Criteria
My condition is at stage 6d of the FAST scale.
I can take medicine in liquid form.
Exclusion Criteria
I am not allergic to cannabinoids or oils like coconut or sesame oil.
Participant Groups
The trial tests an oral mix of THC/CBD against a placebo over 12 weeks to see if it reduces agitation in dementia patients. Participants are randomly assigned to either the drug or placebo group in equal numbers.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: T2:C100Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Cannabidiol (CBD) is already approved in United States, European Union for the following indications:
๐บ๐ธ Approved in United States as Epidiolex for:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
๐ช๐บ Approved in European Union as Epidiolex for:
- Seizures associated with Lennox-Gastaut syndrome
- Seizures associated with Dravet syndrome
- Seizures associated with tuberous sclerosis complex
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of MarylandBaltimore, MD
Howard UniversityWashington, United States
Sun Valley Research CenterImperial, CA
University of Washington SIBCR / VA Puget SoundSeattle, WA
More Trial Locations
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
National Institute on Aging (NIA)Collaborator
Medical University of South CarolinaCollaborator
Alzheimer's Clinical Trials ConsortiumCollaborator
Alzheimer's Therapeutic Research InstituteCollaborator
References
Safety, pharmacodynamics, and pharmacokinetics of multiple oral doses of delta-9-tetrahydrocannabinol in older persons with dementia. [2022]Data on safety, pharmacodynamics, and pharmacokinetics of tetrahydrocannabinol (THC) are lacking in dementia patients.
Prohedonic Effect of Cannabidiol in a Rat Model of Depression. [2022]Accumulating evidence suggests that cannabidiol (CBD) may be an effective and safe anxiolytic agent and potentially also an antidepressant.
Cannabidiol: A New Hope for Patients With Dravet or Lennox-Gastaut Syndromes. [2020]To review the efficacy, safety, pharmacology and pharmacokinetics of pure, plant-derived cannabidiol (CBD; Epidiolex) in the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
Use of Cannabis for Agitation in Patients With Dementia. [2021]Studies have reported changes in the endocannabinoid system in the brain of patients with Alzheimer's disease (AD), playing a role in the pathophysiology of AD. Cannabinoids have been shown to have neuroprotective properties, reduce neuroinflammation, and enhance neurogenesis. Evidence suggests that the utilization of marijuana products containing both tetrahydrocannabinol (THC) and cannabidiol (CBD) or CBD alone have been effective and safe for use in older people with agitation associated with dementia. A review in 2017 summarized positive findings for therapeutic benefits of cannabinoids in agitation of AD and dementia, but there was no definitive conclusion because of varying cannabinoid products. Cannabinoids were shown to be well tolerated, with few short-term side effects. This differs from first-line medications utilized for dementia behaviors, which can have unwanted side effects. Further research regarding the safety, efficacy, and variability of these products in older people is needed.
Study rationale and baseline data for pilot trial of dronabinol adjunctive treatment of agitation in Alzheimer's dementia (THC-AD). [2022]Agitation is a common complication of Alzheimer's dementia (Agit-AD) associated with substantial morbidity, high healthcare service utilization, and adverse emotional and physical impact on care partners. There are currently no FDA-approved pharmacological treatments for Agit-AD. We present the study design and baseline data for an ongoing multisite, three-week, double-blind, placebo-controlled, randomized clinical trial of dronabinol (synthetic tetrahydrocannabinol [THC]), titrated to a dose of 10 mg daily, in 80 participants to examine the safety and efficacy of dronabinol as an adjunctive treatment for Agit-AD. Preliminary findings for 44 participants enrolled thus far show a predominately female, white sample with advanced cognitive impairment (Mini Mental Status Examination mean 7.8) and agitation (Neuropsychiatric Inventory-Clinician Agitation subscale mean 14.1). Adjustments to study design in light of the COVID-19 pandemic are described. Findings from this study will provide guidance for the clinical utility of dronabinol for Agit-AD. ClinicalTrials.gov Identifier: NCT02792257.
NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia (NACTOPAISD): Clinical trial protocol. [2022]Up to 80 % nursing home residents with dementia experiences chronic pain. Contextually, 97 % presents fluctuant neuropsychiatric symptoms (NPS). Among the most challenging is agitation, connected with undertreated pain and managed through neuroleptics doubling death risk. Evidence is accumulating in favor of the involvement of the endocannabinoid system in nociception and NPS. This double-blind, placebo-controlled, randomized trial (NAbiximols Clinical Translation To the treatment of Pain and Agitation In Severe Dementia [NACTOPAISD]) aims at investigating efficacy and safety of oral spray nabiximols, containing ฮ9-tetrahydrocannabinol and cannabidiol (Sativexยฎ), for pain and agitation treatment in severe dementia patients (Mini-Mental State Examination โค 12) over 65. The coprimary endpoints are efficacy on pain and agitation, assessed through the recently validated Italian Mobilization-Observation-Behavior-Intensity-Dementia and the Cohen-Mansfield Agitation Inventory. The secondary endpoint is the evaluation of efficacy duration after wash-out and the assessment of quality of life through the DEMQOL. Any adverse events will be reported. The results undergo statistical analysis plan. NACTOPAISD might provide rationale for a translational safer pain and agitation treatment in severe dementia. It is approved by Calabria Region Ethics Committee and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the Consolidated Standards of Reporting Trials (CONSORT) statements.
Oral THC: CBD cannabis extract in main symptoms of Alzheimer disease: agitation and weight loss. [2023]Ten million new cases of dementia are recorded annually worldwide, with agitation and idiopathic weight loss being the most common symptoms. Several pharmacological therapies have emerged in recent years, but the clinical use of cannabis extracts in older patients with AD is constantly growing. This retrospective, analytical, observational, spontaneous trial aimed to enhance the clinical action of THC: CBD cannabis extract administration in AD patients with severe symptoms such as agitation, weight loss, cognitive impairment, and sleep disturbance.