Study rationale and baseline data for pilot trial of dronabinol adjunctive treatment of agitation in Alzheimer's dementia (THC-AD).

Autor: Cohen LM; Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA., Ash E; Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA., Outen JD; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Vandrey R; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Amjad H; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Agronin M; Department of Mental Health and Clinical Research, Miami Jewish Health, Miami, FL, USA., Burhanullah MH; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Walsh P; Department of Psychiatry, North Shore Medical Center, Salem, MA, USA., Wilkins JM; Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA.; Harvard Medical School, Boston, MA, USA., Leoutsakos JM; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA., Nowrangi MA; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Harper D; Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA.; Harvard Medical School, Boston, MA, USA., Rosenberg PB; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Forester BP; Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA.; Harvard Medical School, Boston, MA, USA.
Jazyk: angličtina
Zdroj: International psychogeriatrics [Int Psychogeriatr] 2021 Oct 11, pp. 1-6. Date of Electronic Publication: 2021 Oct 11.
DOI: 10.1017/S1041610221001150
Abstrakt: 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.
Databáze: MEDLINE