Donepezil

Generic Name: Donepezil

Brand Names: Adlarity, Aricept, Namzaric

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₉NO_₃

CAS Number: 120014-06-4

Unique Ingredient Identifier: 8SSC91326P

Background: In 2016, the global burden of dementia was estimated to be 43.8 million, demonstrating a significant increase from a global prevalence of 20.2 million in 1990. Donepezil, also known as Aricept, is a piperidine derivative acetylcholinesterase inhibitor used in the management of the dementia of Alzheimer's Disease, and in some cases, is used to manage other types of dementia.

Donepezil was first approved by the FDA in 1996, and its extended-release form was approved in combination with Memantine in 2014 to manage moderate and severe forms of Alzheimer's dementia. A donepezil transdermal delivery system, Adlarity, was approved by the FDA in March 2022 for the treatment of Alzheimer's dementia. Though it does not alter the progression of Alzheimer's disease, donepezil is effective in managing the symptoms of its associated dementia.

Indication: Donepezil, administered orally or via transdermal delivery system, is indicated for the treatment of dementia of the Alzheimer's type. It is also available as an extended-release capsule in combination with memantine for the treatment of moderate-to-severe dementia of the Alzheimer's type in patients previously stabilized on 10mg of donepezil hydrochloride once daily.

Off-label uses include the management of vascular dementia, Parkinson's Disease-associated dementia, and Lewy body dementia, amongst others.

Associated Conditions: Alzheimer's Disease (AD), Dementia With Lewy Body Disease, Dementia due to Parkinson's disease, Dementia of the Alzheimer's Type, Vascular Dementia (VaD), Moderate Alzheimer's Type Dementia, Severe Alzheimer's Type Dementia

Clinical Trials

Brain Imaging and Mental Disorders of Aging Intervention

Phase 4

Completed

Conditions: Cognition Disorders

Interventions: Drug: donepezil
Drug: Placebo

First Posted Date: 2005-12-20

Last Posted Date: 2008-08-29

Lead Sponsor: National Institute on Aging (NIA)

Target Recruit Count: 64

Registration Number: NCT00267163

Locations: 🇺🇸
UCLA, The Semel Institute for Neuroscience and Human Behavior, Los Angeles, California, United States

EARTH 413: A Study of Aricept in Hispanic Patients With Mild to Moderate Alzheimer's Disease (AD)

Phase 4

Completed

Conditions: Alzheimer's Disease

First Posted Date: 2005-10-03

Last Posted Date: 2011-04-01

Lead Sponsor: Eisai Inc.

Target Recruit Count: 100

Registration Number: NCT00230568

Locations: 🇺🇸
Clinical Research Center, Jenkintown, Pennsylvania, United States
🇺🇸
University of New Mexico School of Medicine, Department of Psychiatry, Albuquerque, New Mexico, United States
🇺🇸
21st Century Neurology, Phoenix, Arizona, United States

and more 30 locations

Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke

Phase 4

Completed

Conditions: Cerebrovascular Accident

Interventions: Drug: Donepezil
Drug: Galantamine

First Posted Date: 2005-09-28

Last Posted Date: 2017-12-11

Lead Sponsor: University of Pittsburgh

Target Recruit Count: 40

Registration Number: NCT00227994

Locations: 🇺🇸
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Prevention of Postoperative Delirium With Donepezil

Phase 4

Completed

Conditions: Cognitively Normal Elderly Individuals

First Posted Date: 2005-09-22

Last Posted Date: 2011-09-14

Lead Sponsor: Technical University of Munich

Target Recruit Count: 37

Registration Number: NCT00220896

Locations: 🇩🇪
Deps. of Psychiatry and Anaesthesiology, Tech. Universitaet Munich, Munich, Germany

An Open-Label Trial of Donepezil in Fragile X Syndrome

Phase 1

Completed

Conditions: Fragile X Syndrome

Interventions: Drug: donepezil

First Posted Date: 2005-09-22

Last Posted Date: 2012-12-13

Lead Sponsor: Stanford University

Target Recruit Count: 10

Registration Number: NCT00220584

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia

Phase 2

Terminated

Conditions: Schizophrenia

Interventions: Drug: donepezil (5-10 mg/day)
Drug: Placebo

First Posted Date: 2005-09-21

Last Posted Date: 2011-09-20

Lead Sponsor: Birte Glenthoj

Target Recruit Count: 50

Registration Number: NCT00206947

Locations: 🇩🇰
Center for Neuropsychiatric Schizophrenia Research, University of Copenhagen, Dept. F, Bispebjerg Hospital, Copenhagen NV, Denmark
🇩🇰
Danish Research Center for Magnetic Resonance Imaging, Hvidovre Hospital, Hvidovre, Denmark
🇩🇰
Dept. of Psychiatry O, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark

and more 1 locations

Donepezil in Chronic Poststroke Aphasia: a Randomized Controlled Trial

Phase 4

Completed

Conditions: Stroke
Aphasia

First Posted Date: 2005-09-20

Last Posted Date: 2005-09-20

Lead Sponsor: Gabinete Berthier y Martínez

Target Recruit Count: 30

Registration Number: NCT00196690

Locations: 🇪🇸
Gabinete Berthier y Martínez, Malaga, Spain. Centro de Investigaciones Médico-Sanitarias (CIMES), UNiversity of Malaga, Malaga, Spain., Malaga, Spain