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

A Study to Evaluate the Effect of Heat Application on the Delivery Profile of Corplex™ Donepezil Transdermal Delivery System (TDS)

Phase 1
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2018-02-19
Last Posted Date
2018-09-14
Lead Sponsor
Corium, Inc.
Target Recruit Count
24
Registration Number
NCT03438604
Locations
🇺🇸

Celerion, Phoenix, Arizona, United States

A Clinical Study to Evaluate the Pharmacokinetics (PK) of Corplex™ Donepezil Transdermal Delivery System (TDS) Applied to Different Body Locations

Phase 1
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2018-02-14
Last Posted Date
2018-08-07
Lead Sponsor
Corium, Inc.
Target Recruit Count
66
Registration Number
NCT03432195
Locations
🇺🇸

Celerion, Tempe, Arizona, United States

A Skin Irritation Assessment of Once-Weekly Corplex™ Donepezil Transdermal Delivery System

Phase 1
Completed
Conditions
Skin Irritation
Sensitization
Interventions
Drug: Vehicle TDS
First Posted Date
2018-01-12
Last Posted Date
2018-09-14
Lead Sponsor
Corium, Inc.
Target Recruit Count
256
Registration Number
NCT03397862
Locations
🇺🇸

Celerion Inc., Lincoln, Nebraska, United States

A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease

Phase 1
Withdrawn
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2017-10-20
Last Posted Date
2018-11-02
Lead Sponsor
Allergan
Registration Number
NCT03316898
Locations
🇺🇸

Synergy Research Centers, Lemon Grove, California, United States

🇺🇸

Collaborative Neuroscience, Long Beach, California, United States

🇺🇸

Alliance Research, Long Beach, California, United States

and more 3 locations

Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea

Phase 4
Conditions
Sleepiness
OSA
Interventions
First Posted Date
2017-10-03
Last Posted Date
2018-06-27
Lead Sponsor
Associação Fundo de Incentivo à Pesquisa
Target Recruit Count
36
Registration Number
NCT03299257
Locations
🇧🇷

Instituto do Sono, Sao Paulo, Brazil

Octohydroaminoacridine Succinate Tablet for Mild-to-Moderate Alzheimer's Disease

Phase 3
Conditions
Alzheimer Disease
Interventions
First Posted Date
2017-09-14
Last Posted Date
2019-10-22
Lead Sponsor
Shanghai Mental Health Center
Target Recruit Count
600
Registration Number
NCT03283059
Locations
🇨🇳

Shanghai Mental Health Center, Shanghai, Shanghai, China

A Bioequivalence Study of Corplex™ Donepezil Transdermal Delivery System Compared to Aricept®

Phase 1
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2017-08-24
Last Posted Date
2018-08-01
Lead Sponsor
Corium, Inc.
Target Recruit Count
86
Registration Number
NCT03259958
Locations
🇺🇸

Celerion Inc., Phoenix, Arizona, United States

A Multinational, Multi-center, Randomized, Double-blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease

Phase 3
Completed
Conditions
Alzheimer Disease
Interventions
First Posted Date
2017-06-23
Last Posted Date
2021-02-11
Lead Sponsor
Icure Pharmaceutical Inc.
Target Recruit Count
399
Registration Number
NCT03197740
Locations
🇰🇷

46 Sites including Konkuk University Medical Center, Seoul, Korea, Republic of

A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease

Phase 4
Conditions
Cognitive Function
Alzheimer Disease
Interventions
First Posted Date
2017-05-12
Last Posted Date
2017-05-12
Lead Sponsor
Zhejiang Provincial People's Hospital
Target Recruit Count
30
Registration Number
NCT03151382

Combining Donepezil With Perceptual Learning in Normal and Amblyopic Human The Effect of Donepezil on Perceptual Learning in Adult Amblyopia

Phase 4
Completed
Conditions
Amblyopia
Interventions
Behavioral: Single-letter training
Behavioral: Uncrowd training
First Posted Date
2017-04-12
Last Posted Date
2019-01-17
Lead Sponsor
Dennis Levi
Target Recruit Count
20
Registration Number
NCT03109314
Locations
🇺🇸

University of California, Berkeley, Berkeley, California, United States

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