MedPath

Donepezil

Generic Name
Donepezil
Brand Names
Adlarity, Aricept, Namzaric
Drug Type
Small Molecule
Chemical Formula
C24H29NO3
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

CALM-AD

Phase 4
Conditions
Alzheimer's Disease
First Posted Date
2005-09-02
Last Posted Date
2005-12-14
Lead Sponsor
Institute of Psychiatry, London
Target Recruit Count
190
Registration Number
NCT00142324
Locations
🇬🇧

Queen Elizabeth Psychiatric Hospital, Birmingham, United Kingdom

🇬🇧

Department of Psychiatry for the Elderly, Leicester General Hospital, Leicester, United Kingdom

🇬🇧

Institute for Ageing and Health, Newcastle General Hospital, Newcastle, Newcastle upon Tyne, United Kingdom

and more 5 locations

Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy

Phase 2
Conditions
Supranuclear Palsy, Progressive
First Posted Date
2005-08-31
Last Posted Date
2007-09-14
Lead Sponsor
Groupe Hospitalier Pitie-Salpetriere
Target Recruit Count
16
Registration Number
NCT00139373
Locations
🇫🇷

Centre d'Investigation Clinique-HÔPITAL PITIÉ-SALPETRIERE, Paris, France

The Efficacy, Safety, And Tolerability Of Donepezil HCl (E2020) In Patients With CADASIL Who Have Cognitive Impairment

Phase 2
Completed
Conditions
Cognitive Impairment
First Posted Date
2005-02-18
Last Posted Date
2015-11-03
Lead Sponsor
Eisai Limited
Target Recruit Count
165
Registration Number
NCT00103948
Locations
🇺🇸

New York University School of Medicine, New York, New York, United States

🇺🇸

Jose Biller, M.D., Maywood, Illinois, United States

Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease

Phase 3
Completed
Conditions
Dementia
Alzheimer's Disease
First Posted Date
2004-11-10
Last Posted Date
2011-04-01
Lead Sponsor
Eisai Inc.
Target Recruit Count
229
Registration Number
NCT00096473
Locations
🇫🇷

Hôpital Broca-La Rochefoucauld, Paris, France

Phase II Studies Of Donepezil And Ginkgo Biloba In Irradiated Brain Tumor

Phase 2
Completed
Conditions
Radiation Toxicity
Brain and Central Nervous System Tumors
First Posted Date
2003-10-07
Last Posted Date
2021-09-09
Lead Sponsor
Wake Forest University Health Sciences
Target Recruit Count
68
Registration Number
NCT00070161
Locations
🇺🇸

Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States

🇺🇸

Regional Radiation Oncology Center at Rome, Rome, Georgia, United States

🇺🇸

CCOP - Upstate Carolina, Spartanburg, South Carolina, United States

and more 1 locations

Independent Studies of Dextromethorphan and of Donepezil Hydrochloride for Rett Syndrome

Phase 3
Conditions
Rett Syndrome
First Posted Date
2003-09-30
Last Posted Date
2005-06-24
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
90
Registration Number
NCT00069550
Locations
🇺🇸

Kennedy Krieger Institute, Baltimore, Maryland, United States

Improving Memory in Patients With Multiple Sclerosis

Phase 3
Withdrawn
Conditions
Multiple Sclerosis
First Posted Date
2003-06-19
Last Posted Date
2017-04-25
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Registration Number
NCT00062972
Locations
🇺🇸

University Hospital and Medical Center, Stony Brook, New York, United States

Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer

Phase 3
Completed
Conditions
Cognitive/Functional Effects
Delirium
Depression
Lung Cancer
Radiation Toxicity
Interventions
Dietary Supplement: vitamin E
Other: placebo
First Posted Date
2003-05-29
Last Posted Date
2016-07-13
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
9
Registration Number
NCT00006349
Locations
🇺🇸

Medcenter One Health System, Bismarck, North Dakota, United States

🇺🇸

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

🇺🇸

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

and more 12 locations

Donepezil HCl & Cognitive Deficits in Autism

Phase 2
Completed
Conditions
Autistic Disorder
Interventions
Drug: Placebo
First Posted Date
2002-10-16
Last Posted Date
2017-10-05
Lead Sponsor
University of Pittsburgh
Target Recruit Count
34
Registration Number
NCT00047697
Locations
🇺🇸

Western Psychiatric Institute & Clinic, Pittsburgh, Pennsylvania, United States

Memory and Mental Health in Aging

Not Applicable
Completed
Conditions
Memory Disorders
First Posted Date
2002-08-13
Last Posted Date
2013-12-05
Lead Sponsor
Stanford University
Target Recruit Count
200
Registration Number
NCT00043589
Locations
🇺🇸

Aging Clinical Research Center, VA Palo Alto Health Care System, Palo Alto, California, United States

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