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

Published online by Cambridge University Press:  11 October 2021

Leah M. Cohen Open the ORCID record for Leah M. Cohen [Opens in a new window] ,
Eleanor Ash ,
John D. Outen ,
Ryan Vandrey ,
Halima Amjad ,
Marc Agronin ,
M. Haroon Burhanullah ,
Patricia Walsh ,
James M. Wilkins  and
Jeannie-Marie Leoutsakos
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Leah M. Cohen
Affiliation:
Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA
Eleanor Ash
Affiliation:
Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA
John D. Outen
Affiliation:
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Ryan Vandrey
Affiliation:
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Halima Amjad
Affiliation:
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Marc Agronin
Affiliation:
Department of Mental Health and Clinical Research, Miami Jewish Health, Miami, FL, USA
M. Haroon Burhanullah
Affiliation:
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Patricia Walsh
Affiliation:
Department of Psychiatry, North Shore Medical Center, Salem, MA, USA
James M. Wilkins
Affiliation:
Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA Harvard Medical School, Boston, MA, USA
Jeannie-Marie Leoutsakos
Affiliation:
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
Milap A. Nowrangi
Affiliation:
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA
David Harper
Affiliation:
Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA Harvard Medical School, Boston, MA, USA
Paul B. Rosenberg
Affiliation:
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA
Brent P. Forester*
Affiliation:
Division of Geriatric Psychiatry, McLean Hospital, Belmont, MA, USA Harvard Medical School, Boston, MA, USA
*
Correspondence should be addressed to: Brent P. Forester, M.D., M.Sc., Division of Geriatric Psychiatry, McLean Hospital, 115 Mill Street, Belmont, MA 02478, USA. Office: 617-855-3622; Fax: 617-855-3246. Email: [email protected].
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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.

Keywords

Alzheimer’s diseasedementiaagitationneuropsychiatric symptomsdrug trials
Type
Brief Report
Information
International Psychogeriatrics , First View , pp. 1 - 6
Copyright
© International Psychogeriatric Association 2021

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