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

Clinical Efficacy of Ginkgo Biloba Extract in the Treatment of Alzheimer's Disease

First Posted Date
2017-03-24
Last Posted Date
2019-08-07
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
240
Registration Number
NCT03090516
Locations
🇨🇳

Ting Wu, Nanjing, Jiangsu, China

Detecting an Early Response to Donepezil With Measures of Visual Attention

Phase 4
Completed
Conditions
Alzheimer Disease
Interventions
First Posted Date
2017-03-08
Last Posted Date
2021-02-04
Lead Sponsor
NYU Langone Health
Target Recruit Count
25
Registration Number
NCT03073876
Locations
🇺🇸

Winthrop-University Hospital, Mineola, New York, United States

Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA)

Phase 2
Completed
Conditions
Mild-moderate Alzheimer's Disease
Interventions
First Posted Date
2017-02-16
Last Posted Date
2019-08-20
Lead Sponsor
Daehwa Pharmaceutical Co., Ltd.
Target Recruit Count
180
Registration Number
NCT03055741
Locations
🇰🇷

Chonnam National University Hospital, Gwangju-si, Jeollanam-do, Korea, Republic of

🇰🇷

The Catholic University of Korea, Bucheon, ST. Mary's Hospital, Bucheon-si, Gyeonggi-do, Korea, Republic of

🇰🇷

Myongji Hospital, Goyang-si, Gyeonggi-do, Korea, Republic of

and more 13 locations

Study to Evaluate the Effects of BPN14770 on Scopolamine-induced Cognitive Impairment in Healthy Volunteers

Phase 1
Completed
Conditions
Alzheimer Disease
Interventions
First Posted Date
2017-01-24
Last Posted Date
2018-10-16
Lead Sponsor
Tetra Discovery Partners
Target Recruit Count
38
Registration Number
NCT03030105
Locations
🇺🇸

ICON Early Phase Services, LLC, Austin, Texas, United States

Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease

Phase 4
Conditions
Parkinson Disease
Interventions
Drug: Placebos
First Posted Date
2017-01-05
Last Posted Date
2018-03-07
Lead Sponsor
Kyung Hee University Hospital
Target Recruit Count
20
Registration Number
NCT03011476
Locations
🇰🇷

Kyung Hee Universtiy Hospital, Seoul, Korea, Republic of

Memory and Mental Health in Aging

Phase 4
Completed
Conditions
Memory
Interventions
Drug: Placebos
First Posted Date
2016-12-09
Last Posted Date
2017-02-10
Lead Sponsor
Stanford University
Target Recruit Count
198
Registration Number
NCT02988908
Locations
🇺🇸

VA Palo Alto Health Care System, Palo Alto, California, United States

A Phase 1, Corplex™ Donepezil Transdermal System Compared to Oral Aricept®

First Posted Date
2016-11-21
Last Posted Date
2018-08-01
Lead Sponsor
Corium, Inc.
Target Recruit Count
107
Registration Number
NCT02968719
Locations
🇺🇸

Celerion, Phoenix, Arizona, United States

Donepezil Attenuate Postoperative Cognitive Dysfunction

Phase 3
Conditions
Osteoarthritis
Rheumatoid Arthritis
Femoral Head Necrosis
Interventions
Drug: Placebo
First Posted Date
2016-10-07
Last Posted Date
2020-01-30
Lead Sponsor
RenJi Hospital
Target Recruit Count
550
Registration Number
NCT02927522
Locations
🇨🇳

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai, China

TAK-071 Scopolamine-Induced Cognitive Impairment Study

Phase 1
Terminated
Conditions
Healthy Volunteers
Interventions
First Posted Date
2016-09-28
Last Posted Date
2019-06-14
Lead Sponsor
Takeda
Target Recruit Count
18
Registration Number
NCT02918266

A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients

Phase 2
Withdrawn
Conditions
Parkinson's Disease
Interventions
First Posted Date
2016-08-05
Last Posted Date
2017-12-12
Lead Sponsor
University of Chicago
Registration Number
NCT02857244
Locations
🇺🇸

University of Chicago Medical Center, Chicago, Illinois, United States

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