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

A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

Phase 3

Completed

Conditions: Alzheimer Disease

Interventions: Drug: Donepezil (Aricept)
Drug: Placebo

First Posted Date: 2008-03-07

Last Posted Date: 2015-03-05

Lead Sponsor: Pfizer

Target Recruit Count: 249

Registration Number: NCT00630851

Locations: Pfizer Investigational Site

Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

Phase 4

Terminated

Conditions: Diabetic Neuropathic Pain
Chronic Low Back Pain

Interventions: Drug: donepezil
Drug: duloxetine
Drug: donepezil 2.5 mg and duloxetine 30mg
Drug: placebo
Drug: gabapentin

First Posted Date: 2008-02-21

Last Posted Date: 2018-09-11

Lead Sponsor: Wake Forest University

Target Recruit Count: 22

Registration Number: NCT00619983

Locations: 🇺🇸
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States

Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

Phase 2

Terminated

Conditions: Alzheimer's Disease

Interventions: Drug: SSR180711C
Drug: placebo
Drug: donepezil

First Posted Date: 2008-01-28

Last Posted Date: 2009-07-20

Lead Sponsor: Sanofi

Target Recruit Count: 1

Registration Number: NCT00602680

Locations: 🇫🇷
Sanofi-Aventis Administrative Office, Paris, France

A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

Phase 2

Completed

Conditions: Dementia With Lewy Bodies (DLB)

Interventions: Drug: E2020

First Posted Date: 2008-01-22

Last Posted Date: 2014-09-03

Lead Sponsor: Eisai Co., Ltd.

Target Recruit Count: 160

Registration Number: NCT00598650

Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Phase 2

Completed

Conditions: Delirium

Interventions: Drug: donepezil
Drug: Placebo

First Posted Date: 2008-01-04

Last Posted Date: 2014-08-22

Lead Sponsor: Beth Israel Deaconess Medical Center

Target Recruit Count: 16

Registration Number: NCT00586196

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility

Phase 4

Completed

Conditions: Mild to Severe Alzheimer's Disease

Interventions: Drug: Donepezil HCl

First Posted Date: 2007-12-11

Last Posted Date: 2018-09-27

Lead Sponsor: Eisai Inc.

Target Recruit Count: 97

Registration Number: NCT00571064

Locations: 🇺🇸
Senior Care, Birmingham, Alabama, United States
🇺🇸
21st Century Neurology, Phoenix, Arizona, United States
🇺🇸
South Coast Clinical Trials, Anaheim, California, United States

and more 33 locations

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome

Phase 2

Completed

Conditions: Down Syndrome

Interventions: Drug: Donepezil HCl
Drug: Placebo

First Posted Date: 2007-12-10

Last Posted Date: 2021-04-19

Lead Sponsor: Eisai Inc.

Target Recruit Count: 129

Registration Number: NCT00570128

Locations: 🇺🇸
Community Research Foundation, Miami, Florida, United States
🇺🇸
Miami Children's Hospital, Brain Institute, Miami, Florida, United States
🇺🇸
UCSD Pediatric Pharmacology Research Unit, San Diego, California, United States

and more 28 locations