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

Efficacy and Safety of Tianzhi Granule in Mild to Moderate Vascular Dementia

Phase 3
Completed
Conditions
Vascular Dementia
Interventions
Drug: Tianzhi granule and placebo identified to donepezil
Drug: Placebo
First Posted Date
2015-05-27
Last Posted Date
2020-01-07
Lead Sponsor
Dongzhimen Hospital, Beijing
Target Recruit Count
543
Registration Number
NCT02453932
Locations
🇨🇳

Dongzhimen Hospital,Beijing University of Chinese Medicine, Beijing, Beijing, China

Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)

Phase 2
Conditions
Parkinson's Disease
Interventions
First Posted Date
2015-05-21
Last Posted Date
2019-01-29
Lead Sponsor
Yonsei University
Target Recruit Count
80
Registration Number
NCT02450786
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

Post-marketing Surveillance of Donepezil Hydrochloride - Investigation of Long Term Safety and Efficacy of Aricept as Well as Its Proper Use Information in Patients With Dementia With Lewy Bodies (DLB).

Completed
Conditions
Dementia With Lewy Body Disease
Interventions
First Posted Date
2015-05-19
Last Posted Date
2018-07-11
Lead Sponsor
Eisai Co., Ltd.
Target Recruit Count
591
Registration Number
NCT02448784

The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With Dementia

Phase 2
Conditions
Parkinson's Disease
Interventions
First Posted Date
2015-04-14
Last Posted Date
2015-08-06
Lead Sponsor
Inje University
Target Recruit Count
150
Registration Number
NCT02415062
Locations
🇰🇷

Inje university, busan paik hospital, Busan, Korea, Republic of

A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2015-04-02
Last Posted Date
2019-11-04
Lead Sponsor
AstraZeneca
Target Recruit Count
82
Registration Number
NCT02406261
Locations
🇺🇸

Covance Inc, Dallas, Texas, United States

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations

A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)

Phase 4
Completed
Conditions
Dementia, Lewy Body
Lewy Body Disease
Interventions
Drug: Placebo
First Posted Date
2015-01-26
Last Posted Date
2019-01-08
Lead Sponsor
Eisai Co., Ltd.
Target Recruit Count
160
Registration Number
NCT02345213

BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

Phase 2
Completed
Conditions
Alzheimer Disease
Interventions
First Posted Date
2015-01-14
Last Posted Date
2018-11-14
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
329
Registration Number
NCT02337907
Locations
🇫🇷

HOP La Pitié Salpêtrière, Paris, France

🇩🇪

Praxis Dr. med. Volker Schumann, Berlin, Germany

🇫🇷

HOP Pellegrin, Bordeaux, France

and more 57 locations

Donepezil Memory Preservation Post ECT

Not Applicable
Terminated
Conditions
Memory Impairment
Interventions
Drug: Placebo
First Posted Date
2015-01-06
Last Posted Date
2018-07-06
Lead Sponsor
Porter Adventist Hospital
Target Recruit Count
12
Registration Number
NCT02331771
Locations
🇺🇸

Porter Adventist Hospital, Denver, Colorado, United States

Effect of Electroacupuncture Combined With Donepezil for Treating Alzheimer's Disease

Phase 2
Conditions
Cognitive Impairment
Interventions
Procedure: acupuncture
First Posted Date
2014-12-03
Last Posted Date
2017-05-16
Lead Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Target Recruit Count
334
Registration Number
NCT02305836
Locations
🇨🇳

Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences, Beijing, China

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