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

Donepezil in Preventing Delirium in Hospitalized Elderly

Phase 4
Completed
Conditions
Postoperative Complications
Delirium
First Posted Date
2005-09-16
Last Posted Date
2008-03-03
Lead Sponsor
Indiana University Health
Target Recruit Count
30
Registration Number
NCT00182884
Locations
🇺🇸

Methodist Hospital, Clarian Health Partners, Indianapolis, Indiana, United States

Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

Phase 3
Terminated
Conditions
Dementia, Vascular
Dementia, Mixed
Interventions
First Posted Date
2005-09-15
Last Posted Date
2015-03-24
Lead Sponsor
Pfizer
Target Recruit Count
149
Registration Number
NCT00174382
Locations
🇨🇦

Pfizer Investigational Site, Regina, Saskatchewan, Canada

Antidepressant Medication Plus Donepezil for Treating Late-life Depression

Phase 4
Completed
Conditions
Depression
Dementia
Interventions
First Posted Date
2005-09-15
Last Posted Date
2013-02-06
Lead Sponsor
University of Pittsburgh
Target Recruit Count
220
Registration Number
NCT00177671
Locations
🇺🇸

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

Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Phase 4
Terminated
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2005-09-14
Last Posted Date
2013-11-20
Lead Sponsor
Eisai Korea Inc.
Target Recruit Count
40
Registration Number
NCT00165750
Locations
🇰🇷

Cheonnam University Hospital, Gwangju, Korea, Republic of

Alzheimer's Disease Long-term Follow-up Study (ALF Study)

Phase 4
Completed
Conditions
Alzheimer's Disease
First Posted Date
2005-09-14
Last Posted Date
2021-12-30
Lead Sponsor
Eisai Korea Inc.
Target Recruit Count
114
Registration Number
NCT00165724
Locations
🇰🇷

Yeungnam University Hospital, Daegu, Korea, Republic of

🇰🇷

Changwon Fatima Hospital, Changwon, Korea, Republic of

🇰🇷

Bobath Memorial Hospital, Bundang, Korea, Republic of

and more 4 locations

Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

Phase 4
Completed
Conditions
Vascular Dementia
Interventions
First Posted Date
2005-09-14
Last Posted Date
2012-05-04
Lead Sponsor
Eisai Inc.
Target Recruit Count
36
Registration Number
NCT00165763
Locations
🇵🇭

Memory Center, Quezon, Manila, Philippines

🇵🇭

Subic Bay Medical Center, Olongapo, Zambales, Philippines

Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

Phase 3
Completed
Conditions
Dementia, Vascular
First Posted Date
2005-09-14
Last Posted Date
2011-04-01
Lead Sponsor
Eisai Inc.
Target Recruit Count
974
Registration Number
NCT00165737
Locations
🇺🇸

Neurological Associate of Albany PC, Albany, New York, United States

🇺🇸

St. Francis Medical Center, Peoria, Illinois, United States

🇺🇸

University of Texas Mental Sciences Institute, Houston, Texas, United States

and more 2 locations

A Multi-Center, Randomized, Double-Blind, Parallel Group Study With 3 Groups Receiving Placebo, 5 mg of E2020 and 10 mg of E2020

Phase 2
Completed
Conditions
Alzheimer Disease
First Posted Date
2005-09-14
Last Posted Date
2010-01-29
Lead Sponsor
Eisai Limited
Registration Number
NCT00165659

The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With Dementia

Phase 3
Completed
Conditions
Dementia With Parkinson's Disease
First Posted Date
2005-09-14
Last Posted Date
2013-05-10
Lead Sponsor
Eisai Limited
Registration Number
NCT00165815
Locations
🇮🇪

Belfast City Hospital, Belfast, Ireland

🇮🇪

Unit 20 Black Poo Technology Centerl, Blackpool, Ireland

🇩🇪

Parkinson Klinik Wolfach, Wolfach, Germany

and more 1 locations

Study Evaluating Lecozotan SR in Mild to Moderate Alzheimer's Disease (AD)

Phase 2
Completed
Conditions
Alzheimer Disease
Interventions
First Posted Date
2005-09-08
Last Posted Date
2022-05-06
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Target Recruit Count
229
Registration Number
NCT00151398
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