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

Leah M. Cohen, Eleanor Ash, John D. Outen, Ryan Vandrey, Halima Amjad, Marc Agronin, M. Haroon Burhanullah, Patricia Walsh, James M. Wilkins, Jeannie Marie Leoutsakos, Milap A. Nowrangi, David Harper, Paul B. Rosenberg, Brent P. Forester

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1-6
Number of pages6
JournalInternational psychogeriatrics
DOIs
StateAccepted/In press - 2021

Keywords

  • Alzheimer's disease
  • agitation
  • dementia
  • drug trials
  • neuropsychiatric symptoms

ASJC Scopus subject areas

  • Clinical Psychology
  • Gerontology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health

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