Donepezil

Generic Name: Donepezil

Brand Names: Adlarity, Aricept, Namzaric

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₉NO_₃

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 Trials

Phase 1 Clinical Trial of DA-5207 in Healthy Adults

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Aricept 5mg Tablet
Drug: Aricept 10mg Tablet
Drug: DA-5207 A
Drug: DA-5207 B

First Posted Date: 2021-11-19

Last Posted Date: 2023-04-14

Lead Sponsor: Dong-A ST Co., Ltd.

Target Recruit Count: 51

Registration Number: NCT05127746

Locations: 🇰🇷
Jeonbuk National University Hospital, Jeonju, Jeonbuk, Korea, Republic of

Efficacy and Safety of Donepezil and Sodium Oligomannate in Patients With Mild to Moderate Alzheimer's Disease

Not yet recruiting

Conditions: Alzheimer Disease

Interventions: Drug: GV-971
Drug: Donepezil

First Posted Date: 2021-11-10

Last Posted Date: 2021-11-10

Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Target Recruit Count: 150

Registration Number: NCT05114499

Progress of Mild Alzheimer's Disease in Participants on Acupuncture Versus Sham Acupuncture

Not Applicable

Recruiting

Conditions: Alzheimer Disease 1

Interventions: Device: Active acupuncture
Device: Sham acupuncture
Drug: Donepezil Hydrochloride

First Posted Date: 2021-10-15

Last Posted Date: 2024-05-30

Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Target Recruit Count: 240

Registration Number: NCT05078944

Locations: 🇨🇳
Shanghai Institute of Acupuncture, Moxibustion and Meridian Organization, Shanghai, China

Cognition Platform Study in Participants at Risk for Alzheimer's Disease (AD) (MK-0000-413)

Phase 1

Completed

Conditions: Alzheimer's Disease
Mild Cognitive Impairment

Interventions: Drug: Placebo
Drug: Donepezil

First Posted Date: 2021-01-29

Last Posted Date: 2024-10-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 44

Registration Number: NCT04730635

Locations: 🇺🇸
Velocity Clinical Research, Hallandale Beach ( Site 0013), Hallandale Beach, Florida, United States
🇦🇺
Royal Adelaide Hospital-CALHN Memory Trials ( Site 0031), Adelaide, South Australia, Australia
🇺🇸
Insight Clinical Trials ( Site 0020), Beachwood, Ohio, United States

and more 7 locations