Alzheimer’s disease (AD) is a degenerative condition affecting around 6.7 million Americans aged 65 and older. Apart from memory and cognitive decline, neuropsychiatric symptoms (NPS) are highly prevalent in AD, affecting approximately 97% of patients and significantly adding to caregiver burden. Anxiety is a common NPS in AD, with estimates suggesting its prevalence ranges from 25% to 70%. It often correlates with agitation, characterized by challenging behaviors such as combativeness and resistance to care, exacerbating caregiver burden and necessitating higher levels of care like hospitalization. Despite the high prevalence of anxiety and agitation in AD patients, there’s only one FDA-approved medication for agitation, and none specifically for other behavioral or psychological symptoms of dementia. This underscores the urgent need for safe and effective treatments.
Cannabidiol (CBD), a non-intoxicating compound found in cannabis, is gaining attention for its potential therapeutic benefits and minimal side effects. It presents a promising treatment avenue for older adults with AD experiencing anxiety or agitation. Both animal and human studies suggest that CBD can alleviate stress and anxiety with few reported adverse effects. Preliminary research also indicates CBD’s potential neuroprotective properties by inhibiting tau hyperphosphorylation, a key aspect of AD pathology. However, there’s a lack of human studies examining the effects of CBD on anxiety or agitation in AD patients.
To address this gap, an 8-week open-label clinical trial is underway to evaluate the safety and efficacy of a specially formulated high-CBD/low-THC sublingual solution in 12 older adults (ages 55-90) diagnosed with mild to moderate dementia due to Alzheimer’s disease. Primary outcome measures for anxiety include various scales such as the anxiety domain of the Neuropsychiatric Inventory – Clinician Version (NPI-C), Generalized Anxiety Disorder-7 Item Scale (GAD-7), and the Beck Anxiety Index (BAI). Safety outcomes encompass assessments of potential side effects, adverse events, and cognition. Exploratory measures include agitation and aggression domains on the NPI-C, scores on the Cohen-Mansfield Agitation Inventory (CMAI), and caregiver burden using the Zarit Caregiver Burden Interview.
Preliminary results from five patients who completed the trial show a reduction in anxiety symptoms compared to baseline, with some patients also showing improvements in cognition. Informant and clinician-rated measures indicate significant improvement in anxiety over the trial period. Study partners reported a decrease in anxiety symptoms ranging from 29% to 100% on the BAI, and reductions ranging from 60% to 88% on the NPI-C. Patients’ self-report scales showed more variable results, with four out of five patients reporting a decrease in anxiety symptoms on the BAI. Data on agitation symptoms were consistent with primary outcomes, as all patients showed reductions in agitation symptoms as measured by the CMAI. No serious adverse events were reported by patients or study partners.
While data collection is ongoing, the initial findings suggest promising reductions in anxiety symptoms among patients. These results underscore the importance of multiple-reporter systems in studies involving patients with mild to moderate AD. These findings will inform a planned randomized, placebo-controlled trial aimed at further assessing the clinical efficacy and safety of high-CBD products in older adults with AD.
“Caring for Behavioral Symptoms of Dementia (CBD): A New Investigation into Cannabidiol for the Treatment of Anxiety and Agitation in Alzheimer’s Dementia.” Www.Ajgponline.Org, 5 Jun. 2024, www.ajgponline.org/article/S1064-7481(24)00183-0/abstract. Accessed 5 Jun. 2024.
