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
Associated Therapies
-

Study Evaluating The Coadministration of Begacestat And Donepezil

First Posted Date
2009-08-17
Last Posted Date
2011-04-04
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
47
Registration Number
NCT00959881
Locations
🇺🇸

Pfizer Investigational Site, Overland Park, Kansas, United States

Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

First Posted Date
2009-07-29
Last Posted Date
2013-01-31
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
274
Registration Number
NCT00948909
Locations
🇧🇬

Site Reference ID/Investigator# 22946, Sofia, Bulgaria

🇿🇦

Site Reference ID/Investigator# 20263, Richards Bay, South Africa

🇬🇧

Site Reference ID/Investigator# 20183, Bradford, United Kingdom

and more 26 locations

Donepezil and the Risk of Falls in Seniors With Cognitive Impairment

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-07-08
Last Posted Date
2019-01-07
Lead Sponsor
Lawson Health Research Institute
Target Recruit Count
60
Registration Number
NCT00934531
Locations
🇨🇦

St. Joseph's Health Care London, Parkwood Hospital, London, Ontario, Canada

Donepezil Treatment for Sleep Apnea Patients

First Posted Date
2009-06-03
Last Posted Date
2009-06-03
Lead Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
Target Recruit Count
60
Registration Number
NCT00912457
Locations
🇧🇷

Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia, Sao Paulo, Brazil

Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's Disease

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-06-03
Last Posted Date
2018-05-08
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
23
Registration Number
NCT00912808

Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease

First Posted Date
2009-05-08
Last Posted Date
2013-01-31
Lead Sponsor
Pfizer
Target Recruit Count
526
Registration Number
NCT00895895
Locations
🇿🇦

Pfizer Investigational Site, Cape Town, South Africa

BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-04-24
Last Posted Date
2015-07-30
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
32
Registration Number
NCT00887601

Enhancing Rehabilitation After Stroke

Phase 3
Conditions
Interventions
First Posted Date
2009-03-24
Last Posted Date
2013-03-05
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
200
Registration Number
NCT00868010
Locations
🇺🇸

Hillside Rehabilitation Hospital, Warren, Ohio, United States

🇺🇸

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States

Donepezil and Memantine in Moderate to Severe Alzheimer's Disease

First Posted Date
2009-03-20
Last Posted Date
2009-03-20
Lead Sponsor
King's College London
Target Recruit Count
800
Registration Number
NCT00866060
Locations
🇬🇧

Institute of Psychiatry, London, United Kingdom

Mayo Acute Stroke Trial for Enhancing Recovery

Phase 2
Completed
Conditions
Interventions
First Posted Date
2008-12-10
Last Posted Date
2021-07-30
Lead Sponsor
Mayo Clinic
Target Recruit Count
33
Registration Number
NCT00805792
Locations
🇺🇸

Mayo Clinic, Jacksonville, Florida, United States

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