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

Investigating the Cholinergic Contribution to Gait Dysfunction in Parkinson's Disease

Phase 2
Recruiting
Conditions
Parkinson Disease
Interventions
First Posted Date
2025-04-01
Last Posted Date
2025-04-01
Lead Sponsor
University of Virginia
Target Recruit Count
5
Registration Number
NCT06903910
Locations
🇺🇸

University of Virginia, Charlottesville, Virginia, United States

Rivastigmine Mini-Tablet for Alzheimer's Disease

Not yet recruiting
Conditions
Alzheimer's Disease
Interventions
Drug: Rivastigmine Mini-Tablet
First Posted Date
2025-02-14
Last Posted Date
2025-02-20
Lead Sponsor
Peking University First Hospital
Target Recruit Count
1000
Registration Number
NCT06828289

Phenserine on the Alzheimer's Treatment Horizon, Study 1

Phase 1
Not yet recruiting
Conditions
Alzheimer Disease
Mild Cognitive Impairment
Interventions
First Posted Date
2025-01-14
Last Posted Date
2025-01-14
Lead Sponsor
Helse Stavanger HF
Target Recruit Count
16
Registration Number
NCT06774261

Acetylcholinesterase Inhibitor in Anorexia Nervosa: Multicenter, Double-Blind, Placebo-Controlled Trial

Phase 2
Not yet recruiting
Conditions
Anorexia Nervosa Restricting Type
Interventions
First Posted Date
2024-11-14
Last Posted Date
2024-11-14
Lead Sponsor
Centre Hospitalier St Anne
Target Recruit Count
147
Registration Number
NCT06687993

An Open Trial of a Novel Pharmacotherapy for Habit Modification in Anorexia Nervosa

Phase 2
Not yet recruiting
Conditions
Anorexia Nervosa
Interventions
First Posted Date
2024-07-25
Last Posted Date
2025-01-17
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
10
Registration Number
NCT06518941
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

Clinical Evaluation of Acupuncture Treatment on Alzheimer's Disease in APOE e4 Carriers and Non-Carriers

Not Applicable
Recruiting
Conditions
Alzheimer Disease
Cognitive Impairment
Interventions
Other: Acupuncture
Other: Sham Acupuncture
First Posted Date
2024-05-16
Last Posted Date
2025-05-21
Lead Sponsor
ZhanYJ
Target Recruit Count
176
Registration Number
NCT06417086
Locations
🇨🇳

Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China

To Explore the Therapeutic Potential of Jiedu Yizhi Formula for Alzheimer 's Disease

Early Phase 1
Completed
Conditions
Ensure the Legality and Compliance of the Testing Process
Interventions
Drug: Jiedu Yizhi Formula
First Posted Date
2024-05-01
Last Posted Date
2024-05-02
Lead Sponsor
Changchun University of Chinese Medicine
Target Recruit Count
62
Registration Number
NCT06393413
Locations
🇨🇳

Changchun University of Traditional Chinese Medicine, Changchun, Jilin, China

A Single Dose Escalation Study of HHT201 in Healthy Subjects

Phase 1
Not yet recruiting
Conditions
Alzheimer Disease
Interventions
First Posted Date
2024-04-18
Last Posted Date
2024-04-18
Lead Sponsor
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
Target Recruit Count
64
Registration Number
NCT06373094
Locations
🇨🇳

Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center), Taizhou, Zhe Jiang, China

Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007)

Phase 1
Active, not recruiting
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2024-02-29
Last Posted Date
2024-08-07
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
28
Registration Number
NCT06285240
Locations
🇺🇸

Velocity Clinical Research, Hallandale Beach ( Site 0001), Hallandale Beach, Florida, United States

🇺🇸

CenExel iResearch, LLC ( Site 0003), Decatur, Georgia, United States

🇺🇸

CenExel iResearch, LLC ( Site 0004), Savannah, Georgia, United States

Effect of Acetylcholinesterase Inhibitors on Bone Metabolism

Phase 2
Recruiting
Conditions
Osteoporosis
Interventions
Drug: Placebo
First Posted Date
2023-09-18
Last Posted Date
2025-02-05
Lead Sponsor
Duke University
Target Recruit Count
45
Registration Number
NCT06041789
Locations
🇺🇸

Duke Memory Disorders Clinic, Durham, North Carolina, United States

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