CBD Oil For Dementia

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Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer’s Disease This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of Overview Name: Cannabidiol Synonyms: CBD, Epidiolex Therapy Type: Small Molecule (timeline) Target Type: Other Neurotransmitters (timeline) Condition(s): Alzheimer’s Disease U.S.

Effects of THC-Free CBD Oil on Agitation in Patients With Alzheimer’s Disease

This is a randomized, double-blinded, placebo-controlled, crossover trial that aims to 1) determine the efficacy of THC-free cannabidiol (CBD oil) in reducing the severity of agitation among participants and 2) determine whether THC-free CBD oil can reduce the burden on caregivers and increase the participants’ quality of life.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Major Neurocognitive Disorder With Aggressive Behavior Drug: THC-free CBD Oil Drug: Placebo Phase 2

Individuals with Alzheimer’s and other forms of dementia often go through a period of significant behavioral and psychological symptoms of dementia (BPSD). It is estimated that up to 90% of persons with dementia (PWD) experience behavior problems at some point. BPSDs can be challenging for both unpaid family caregivers as well as paid caregivers. Family caregivers provide the bulk of care for PWD and number over 15 million. One of the most common types of BPSDs is agitation with a prevalence of up to 87%, based on a recent systematic review. Agitation can lead to impaired daily functioning, prolongation of hospitalization, reduced time to institutionalization, and is associated with higher mortality. Additionally, agitated behavior is associated with increased injury to both patients and caregivers. Based on the 2018 Alzheimer’s disease drug development pipeline report almost 70% of clinical trials related to BPSD are dedicated to agitation behavior. Finding ways to address agitation is necessary to improve overall quality of life for PWD and their caregivers. Currently, there are no medications available specifically for the treatment of BPSDs. The use of benzodiazepines, antipsychotics and mood stabilizing agents are common, but the risks and side effects often outweigh any benefits.

Several small studies have investigated the use of cannabinoids in the treatment of pathology and symptomology of Alzheimer’s disease (AD), as well as treatment of the agitation component of BPSD. A handful of these studies showed that the symptoms of BPSD were decreased with the use of cannabinoids. However, due to small sample sizes, study design, and short trial duration of these studies, the efficacy of these agents on BPSD cannot be confirmed. In addition, cannabinoids have demonstrated anti-oxidant and anti-inflammatory effects, and both processes have been indicated as major contributors to the neurologic effects of AD. Some evidence exists that agitation is related to this neuroinflammatory process. This study will examine the effects of cannabinoids on the behavioral and psychological symptoms of individuals with a dementia diagnosis.

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Overview

Name: Cannabidiol
Synonyms: CBD, Epidiolex
Therapy Type: Small Molecule (timeline)
Target Type: Other Neurotransmitters (timeline)
Condition(s): Alzheimer’s Disease
U.S. FDA Status: Alzheimer’s Disease (Phase 2)
Approved for: Seizures in Dravet syndrome, Lennox-Gastaut syndrome or tuberous sclerosis complex

Background

Cannabidiol is a major active compound of the cannabis plant. It is structurally related to tetrahydrocannabinol (THC), but does not produce a high. CBD is also abundant in hemp plants, which have little to no THC, making industrial hemp the usual source of THC-free CBD oil. In many locales, hemp-derived CBD is not subject to cannabis laws, and is freely available as capsules, drops or oil suspensions, or in transdermal patches, topical lotions, or salves. CBD has been studied in clinical trials for anxiety, addiction, cognition, movement disorders, pain, and other conditions, with no strong evidence yet for its effectiveness. Nonetheless, it is widely promoted and used for these and other maladies.

In 2018, an oral solution of CBD was approved in the U.S. to treat rare forms of severe childhood epilepsy. Common side effects include sleepiness, poor sleep, decreased appetite, diarrhea, and fatigue. This formulation can also cause an increase in liver enzymes, and interferes with metabolism of other medications.

Like the THC formulations nabilone and dronabinol, in Alzheimer’s, CBD is mainly being evaluated for treatment of agitation and aggression with this disease.

In preclinical work, extensive studies with CBD in cell and animal models of Aβ-induced neurotoxicity found it had multiple actions on Aβ production, tau phosphorylation and aggregation, oxidative stress, inflammation, and neurogenesis (reviewed by Watt and Karl, 2017; also see Khodadadi et al., 2021). A combination of CBD and THC was reported to preserve memory function and reduced astrogliosis and inflammation in APP/PS1 mice, with the combination more effective than either alone (Aso et al., 2015). CBD is reportedly neuroprotective in models of tauopathy and stroke (e.g. see Kreilaus et al., 2022; Ceprian et al., 2017).

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CBD’s mechanism of action is unclear. It has low affinity for the cannabinoid receptors CB1 and CB2; instead, it has been proposed to act through TRPV cation channels, the peroxisome proliferation receptor gamma (PPARγ), novel G protein coupled receptors, and serotonin receptors (reviewed by Vitale et al., 2021).

Previous small trials of CBD in Parkinson’s and Huntington’s diseases found no improvement in symptoms, but the PD patients on treatment reported higher quality of life (Chagas et al., 2014; Consroe et al., 1991).

Findings

From 2017-2019, Tikun Olam Pharmaceuticals ran a 64-person Phase 2 trial in Israel testing Avidekel oil, a high CBD/low THC cannabis extract, for the treatment of agitation and aggression in dementia patients. The oil contains 30 percent CBD and 1.5 percent THC. Participants received active or placebo drops under the tongue three times a day for 16 weeks. The primary outcome was a reduction of four points on the Cohen-Mansfield Agitation Inventory; secondary was change on the Neuropsychiatric Inventory-Nursing Home version. According to a published abstract, 72 percent of participants taking CBD oil achieved the primary outcome versus 30 percent on placebo. The average reduction on CBD was 13.3 points versus 2.3 points on placebo. NPI-NH scores were reported to be significantly better with treatment (Hermush et al., 2020; 68, see (Suppl 1):S86 abstract A202 page 86).

In January 2021, an open-label Phase 1 trial began testing an eight-week course of high CBD/low THC oil in 12 people with mild to moderate AD and anxiety and aggression. The custom-formulated hemp extract is given under the tongue twice a day. A target dose of 45 mg CBD per day also delivers approximately 1 mg THC. The primary endpoint is the clinician impression of anxiety from the Neuropsychiatric Inventory-C; other endpoints are additional measures of anxiety, as well as safety and side effects, cognition, and caregiver burden. An optional 12-month extension with similar, commercially available CBD products is offered. According to a presentation at CTAD in November 2021, one person had completed the single-center study at McLean Hospital in Massachusetts. The trial was planned to end in January 2022.

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In February 2021, a Phase 2 trial started to assess the effectiveness of a THC-free CBD oil to treat agitation in people with AD dementia or mixed AD dementia. The trial will enroll 40 participants for a six-week regimen of hemp-derived CBD oil capsules or a matching placebo. The dose begins at 30 mg daily, titrating up to 90 mg, or the highest tolerated dose. Primary outcomes are change in Cohen-Mansfield Agitation Inventory, caregiver burden, and quality of life of patient and caregiver. Secondary measures include the Neuropsychiatric Inventory, MMSE, and sleep quality. The single-center study at Eastern Virginia Medical School in Norfolk is expected to finish in June 2022

In April 2021, a study began enrolling older people with mild cognitive impairment who carry the ApoE4 allele, to compare the effects of a CBD or homotaurine on cognition, daily function, and depression. The single-center, Phase 4 study is ongoing in Greece. It will randomize 90 patients to 5 percent CBD oil, homotaurine, or no intervention. Twenty primary outcomes include the MMSE, MoCA, a cognitive battery, dementia ratings, measures of anxiety and depression, and CSF biomarkers of BDNF, tau, inflammation, and oxidative stress. The trial will run through December 2022.

CBD is also being tested for motor symptoms and pain in Parkinson’s disease. Other active studies include amyotrophic lateral sclerosis, psychosis, anxiety, autism, insomnia, pain conditions, and substance use disorders, among others.

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