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
-

To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease

First Posted Date
2010-05-18
Last Posted Date
2011-05-13
Lead Sponsor
AstraZeneca
Target Recruit Count
40
Registration Number
NCT01125683
Locations
🇺🇦

Research Site, Vinnytsia, Ukraine

Randomized Controlled Study of Donepezil in Fragile X Syndrome

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-05-11
Last Posted Date
2016-03-17
Lead Sponsor
Stanford University
Target Recruit Count
45
Registration Number
NCT01120626
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Acute Effects Of Donepezil On Brain Perfusion And Memory In Subjects With Cognitive Impairment And Mild Alzheimer's Disease

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2010-03-09
Last Posted Date
2013-09-12
Lead Sponsor
Pfizer
Target Recruit Count
18
Registration Number
NCT01082965
Locations
🇺🇸

Pfizer Investigational Site, Philadelphia, Pennsylvania, United States

A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-01-07
Last Posted Date
2010-05-10
Lead Sponsor
AstraZeneca
Target Recruit Count
20
Registration Number
NCT01044342
Locations
🇫🇷

Research Site, Rouffach, France

Drug-Drug Interaction Study With Aricept® (Donepezil)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2010-01-05
Last Posted Date
2011-01-25
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
18
Registration Number
NCT01042314
Locations
🇺🇸

Parexel International - Baltimore Epcu, Baltimore, Maryland, United States

The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil

Early Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-12-03
Last Posted Date
2011-02-08
Lead Sponsor
AstraZeneca
Target Recruit Count
155
Registration Number
NCT01024660
Locations
🇿🇦

Research Site, Roodepoort, South Africa

🇨🇦

Reearch Site, Quebec, Canada

Clinical Trial of Donepezil Between the Patients With Alzheimer's Disease and Mixed Dementia

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-12-02
Last Posted Date
2016-01-06
Lead Sponsor
Samsung Medical Center
Target Recruit Count
88
Registration Number
NCT01023867
Locations
🇰🇷

Samsung Medical Center, Seoul City, Korea, Republic of

Clinical Trial of Donepezil Between the Naive Group and the Switching Group

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-12-02
Last Posted Date
2016-01-06
Lead Sponsor
Samsung Medical Center
Target Recruit Count
72
Registration Number
NCT01023425
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

First Posted Date
2009-11-24
Last Posted Date
2018-06-06
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
242
Registration Number
NCT01018875
Locations
🇺🇦

Site Reference ID/Investigator# 24565, Kherson, Ukraine

🇷🇺

Site Reference ID/Investigator# 22636, Moscow, Russian Federation

🇷🇺

Site Reference ID/Investigator# 22635, St. Petersburg, Russian Federation

and more 18 locations

Multi-centre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated With Parkinson's Disease

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2009-11-17
Last Posted Date
2017-09-25
Lead Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Target Recruit Count
64
Registration Number
NCT01014858
Locations
🇬🇧

Newcastle, Newcastle Upon Tyne, Tyne and Wear, United Kingdom

🇬🇧

Cambridge Centre for Brain Repair, Cambridge, United Kingdom

🇬🇧

Royal Bournemouth & Christchurch Hospitals NHS Foundation Trust, Dorset, United Kingdom

and more 19 locations
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