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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 Phase 2 Clinical Study to Explore the Optimal Dosage/Administration of PM012 Tablet in Alzheimer's Disease

Phase 2
Recruiting
Conditions
Mild Alzheimer Disease
Interventions
First Posted Date
2023-04-13
Last Posted Date
2023-04-18
Lead Sponsor
Mediforum Ltd., Co.
Target Recruit Count
312
Registration Number
NCT05811000
Locations
🇰🇷

Mediforum, Seoul, Seongdon-gu, Korea, Republic of

Randomized Clinical Trial of Donepezil for the Treatment of Mild Cognitive Impairment in Parkinson's Disease

Phase 2
Not yet recruiting
Conditions
Parkinson Disease
Mild Cognitive Impairment
Interventions
First Posted Date
2023-02-02
Last Posted Date
2023-09-28
Lead Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Target Recruit Count
120
Registration Number
NCT05709301

Technical R&D and Demonstration of Intelligent Medical Care in Alzheimer's Disease's Management

Not Applicable
Recruiting
Conditions
Alzheimer Disease
Subjective Cognitive Decline
Mild Cognitive Impairment
Mild Dementia
Interventions
Device: Transcutaneous electrical acupoint stimulation&Music therapy
First Posted Date
2022-12-07
Last Posted Date
2022-12-13
Lead Sponsor
Shaanxi Hospital of Traditional Chinese Medicine
Target Recruit Count
150
Registration Number
NCT05641480
Locations
🇨🇳

Shaanxi Hospital of Traditional Chinese Medicine,, Xi'an, Shaanxi, China

🇨🇳

Shaanxi Hospital of Traditional Chinese Medicine, Xi'an, Shaanxi, China

Study of VYNT-0126 in the Treatment of Rett Syndrome in Adult Patients

Phase 2
Not yet recruiting
Conditions
Rett Syndrome
Interventions
Drug: Placebo
First Posted Date
2022-11-23
Last Posted Date
2022-11-23
Lead Sponsor
Vyant Bio
Target Recruit Count
48
Registration Number
NCT05625568

Donepezil Prevents Urinary Retention After Extensive Total Hysterectomy

Early Phase 1
Conditions
Urinary Retention After Procedure
Interventions
Other: Usual care
First Posted Date
2022-09-15
Last Posted Date
2022-09-15
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
108
Registration Number
NCT05540977
Locations
🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Efficacy of Chinese Traditional Medicine "Smart Soup" in Cognition and Behavior Regulation in Alzheimer's Disease

Phase 2
Recruiting
Conditions
Mild Cognitive Impairment
Alzheimer Disease
Interventions
First Posted Date
2022-09-14
Last Posted Date
2022-09-14
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
180
Registration Number
NCT05538507
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, China

Immunohistochemical Study of Neurodegenerative Diseases

Not Applicable
Recruiting
Conditions
Alzheimer Disease
Lewy Body Disease
Neurodegenerative Diseases
Interventions
Biological: Detection of cytof in peripheral PBMC
First Posted Date
2022-08-26
Last Posted Date
2023-09-14
Lead Sponsor
First Affiliated Hospital of Zhejiang University
Target Recruit Count
100
Registration Number
NCT05518409
Locations
🇨🇳

Department of Psychiatry, First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China

Effect of Donepezil on Speech Recognition in Cochlear Implant Users

Early Phase 1
Active, not recruiting
Conditions
Bilateral Sensorineural Hearing Loss
Interventions
Drug: Placebo
First Posted Date
2022-06-29
Last Posted Date
2025-04-03
Lead Sponsor
Vanderbilt University Medical Center
Target Recruit Count
50
Registration Number
NCT05438264
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

A Clinical Trial to Access Pharmacokinetic Profiles and Safety of IVL3003.

Phase 1
Active, not recruiting
Conditions
Alzheimer Disease
Interventions
First Posted Date
2022-04-26
Last Posted Date
2024-12-19
Lead Sponsor
Inventage Lab., Inc.
Target Recruit Count
62
Registration Number
NCT05345509
Locations
🇦🇺

Nucleus Network, Melbourne, Australia

Donepezil for Oxaliplatin-induced Neuropathy Peripheral Neuropathy: Proof of Concept Study

Phase 2
Completed
Conditions
Digestive Oncology
Supportive Care
Interventions
Drug: PLACEBO
First Posted Date
2022-02-24
Last Posted Date
2024-04-05
Lead Sponsor
University Hospital, Clermont-Ferrand
Target Recruit Count
77
Registration Number
NCT05254639
Locations
🇫🇷

Hôpital privé d'Antony, Antony, France

🇫🇷

Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France

🇫🇷

CH d'Argenteuil, Argenteuil, France

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