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

Donepezil in Treating Young Patients With Primary Brain Tumors Previously Treated With Radiation Therapy to the Brain

Early Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Long-term Effects Secondary to Cancer Therapy in Children
Neurotoxicity
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity

Interventions: Drug: Donepezil

First Posted Date: 2007-03-28

Last Posted Date: 2018-09-07

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 14

Registration Number: NCT00452868

Locations: 🇺🇸
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
🇺🇸
Tufts-NEMC Cancer Center, Boston, Massachusetts, United States

Efficacy Study of a ZT-1 Implant in Patients Suffering From Alzheimer's Disease

Not Applicable

Completed

Conditions: Moderate Alzheimer's Disease

Interventions: Drug: ZT-1
Drug: Donepezil

First Posted Date: 2007-01-18

Last Posted Date: 2015-01-14

Lead Sponsor: Debiopharm International SA

Target Recruit Count: 228

Registration Number: NCT00423228

Locations: 🇦🇺
Central Coast Neuroscience Research, East Gosford, New South Wales, Australia
🇦🇺
Hornsby-Kuring-gai Health Service, Hornsby, New South Wales, Australia
🇦🇺
The Prince Charles Hospital, Chermside, Queensland, Australia

and more 24 locations

Donepezil and Brain Activity Patterns in Those at Risk For Alzheimer's Disease

Phase 1

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: donepezil

First Posted Date: 2006-12-07

Last Posted Date: 2018-02-05

Lead Sponsor: Vanderbilt University

Target Recruit Count: 41

Registration Number: NCT00408525

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

Phase 4

Completed

Conditions: Alzheimer's Disease

Interventions: Drug: Donepezil

First Posted Date: 2006-09-27

Last Posted Date: 2022-01-04

Lead Sponsor: Eisai Korea Inc.

Target Recruit Count: 199

Registration Number: NCT00381381

Locations: 🇰🇷
Seoul National University Bundang Hospital, Bundang, Korea, Republic of
🇰🇷
Jeonju City Welfare Hospital, Jeonju, Korea, Republic of
🇰🇷
Hallym University Medical Center, Changwon, Korea, Republic of

and more 12 locations

Functional Brain Imaging of Medication Treatment Response in Mild Alzheimer's Disease Patients

Phase 4

Terminated

Conditions: Alzheimer's Disease

Interventions: Drug: Razadyne ER
Drug: Aricept

First Posted Date: 2006-08-29

Last Posted Date: 2013-04-11

Lead Sponsor: Duke University

Target Recruit Count: 4

Registration Number: NCT00369603

Locations: 🇺🇸
Joseph & Kathleen Bryan Alzheimer's Disease Research Unit, Durham, North Carolina, United States

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

Phase 3

Completed

Conditions: Brain Tumors
Metastatic Disease

Interventions: Drug: Placebo
Drug: donepezil hydrochloride

First Posted Date: 2006-08-29

Last Posted Date: 2021-10-20

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 198

Registration Number: NCT00369785

Locations: 🇺🇸
Gundersen Lutheran Center for Cancer and Blood, La Crosse, Wisconsin, United States
🇺🇸
United States Air Force Medical Center - Wright-Patterson, Wright-Patterson Air Force Base, Ohio, United States
🇺🇸
Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States

and more 13 locations