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

Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Adult
Interventions
First Posted Date
2007-08-22
Last Posted Date
2008-04-22
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
25
Registration Number
NCT00519298

Memantine Versus Donepezil in Early Stages of Alzheimer's Disease

Phase 4
Completed
Conditions
Dementia, Alzheimer Type
Interventions
First Posted Date
2007-07-23
Last Posted Date
2008-12-29
Lead Sponsor
Hospital Miguel Servet
Target Recruit Count
64
Registration Number
NCT00505167
Locations
🇪🇸

Hospital de Barbastro, Barbastro, Huesca, Spain

🇪🇸

Hospital Royo Villanova, Zaragoza, Spain

🇪🇸

Cenro de especialidades San José. Hospital Miguel Servet, Zaragoza, Spain

Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease

Phase 2
Completed
Conditions
Alzheimer Disease
Interventions
First Posted Date
2007-07-13
Last Posted Date
2014-07-23
Lead Sponsor
AstraZeneca
Target Recruit Count
659
Registration Number
NCT00501111
Locations
🇬🇧

Research Site, Swindon, United Kingdom

Impact of Cholinesterase Inhibitors on Driving Ability in Healthy Older Adults

Phase 4
Completed
Conditions
Mental Health
Geriatrics
Interventions
Drug: Placebo (cornstarch)
First Posted Date
2007-06-04
Last Posted Date
2019-05-10
Lead Sponsor
Sunnybrook Health Sciences Centre
Target Recruit Count
22
Registration Number
NCT00482001
Locations
🇨🇦

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

🇨🇦

Lakehead University, Thunder Bay, Ontario, Canada

The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients

Phase 4
Completed
Conditions
Alzheimer Disease
Sleep Apnea, Obstructive
Interventions
Drug: Placebo
First Posted Date
2007-05-31
Last Posted Date
2007-12-04
Lead Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
Target Recruit Count
65
Registration Number
NCT00480870
Locations
🇧🇷

Instituto do Sono, Sao Paulo, Brazil

Neural Correlates In Mild Alzheimer's Disease

Phase 4
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2007-05-24
Last Posted Date
2021-11-10
Lead Sponsor
Eisai Inc.
Target Recruit Count
14
Registration Number
NCT00477659
Locations
🇺🇸

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease

Phase 3
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2007-05-24
Last Posted Date
2014-07-11
Lead Sponsor
Eisai Inc.
Target Recruit Count
1467
Registration Number
NCT00478205
Locations
🇺🇸

MedTrials, Inc., Hickory, North Carolina, United States

Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease

Not Applicable
Completed
Conditions
Alzheimer Disease
Caregivers
First Posted Date
2007-05-01
Last Posted Date
2007-05-07
Lead Sponsor
Pfizer
Target Recruit Count
300
Registration Number
NCT00467766
Locations
🇺🇸

Aging and Dementia Research Center, Silberstein Institute, NYU School of Medicine, New York, New York, United States

🇦🇺

Prince of Wales Hospital, Randwick, New South Wales, Australia

🇬🇧

University of Manchester, Division of Psychiatry, Manchester, United Kingdom

Donepezil Double Blind Trial for ECT Memory Disfunction

Phase 4
Conditions
Schizoaffective Disorder
Schizophreniform Disorder
Schizophrenia
Interventions
First Posted Date
2007-04-24
Last Posted Date
2009-01-27
Lead Sponsor
BeerYaakov Mental Health Center
Target Recruit Count
40
Registration Number
NCT00465283
Locations
🇮🇱

Beer Yaakov MHC, Beer Yaacov, Israel

Aricept to Improve Functional Tasks in Vascular Dementia

First Posted Date
2007-04-06
Last Posted Date
2021-02-17
Lead Sponsor
Kessler Foundation
Target Recruit Count
18
Registration Number
NCT00457769
Locations
🇺🇸

Kessler Foundation, West Orange, New Jersey, United States

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