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
Associated Therapies
-

Effects of Donepezil and Memantine on Cognitive Functions After a Sleep Deprivation Challenge in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-10-27
Last Posted Date
2015-02-04
Lead Sponsor
Qualissima
Target Recruit Count
36
Registration Number
NCT01461174
Locations
🇫🇷

CIC, Lille, France

🇫🇷

MEDES, Toulouse, France

Efficacy and Safety Study of Shenwu Capsule

First Posted Date
2011-10-14
Last Posted Date
2014-10-10
Lead Sponsor
North China Pharmaceutical Group Corporation
Target Recruit Count
324
Registration Number
NCT01451749
Locations
🇨🇳

Dongzhimen Hospital,BUCM, Beijing, China

Donepezil Trial for Motor Recovery in Acute Stroke

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2011-09-29
Last Posted Date
2024-04-12
Lead Sponsor
Imperial College London
Registration Number
NCT01442766
Locations
🇬🇧

Charing Cross Hospital, Imperial College Academic Health Science Centre, London, United Kingdom

Donepezil 10 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-09-23
Last Posted Date
2011-09-23
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
36
Registration Number
NCT01439230
Locations
🇨🇦

Anapharm, Montreal, Quebec, Canada

Donepezil 10 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-09-23
Last Posted Date
2011-09-23
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
26
Registration Number
NCT01439243
Locations
🇨🇦

Anapharm, Montreal, Quebec, Canada

Assessment of Cholinergic and Cognitive Function Using Pharmacologic ASL-Perfusion MRI

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2011-06-23
Last Posted Date
2013-01-04
Lead Sponsor
Hebrew SeniorLife
Target Recruit Count
60
Registration Number
NCT01379001

Comparative Research of Alzheimer's Disease Drugs

First Posted Date
2011-05-30
Last Posted Date
2017-02-27
Lead Sponsor
Indiana University
Target Recruit Count
200
Registration Number
NCT01362686
Locations
🇺🇸

Touchpoint, Fishers, Indiana, United States

🇺🇸

Methodist Center for Geriatric Medicine, Indianapolis, Indiana, United States

🇺🇸

University Clinical Neurology, Indianapolis, Indiana, United States

and more 2 locations

Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fasting Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-01-13
Last Posted Date
2012-07-20
Lead Sponsor
Ranbaxy Laboratories Limited
Target Recruit Count
32
Registration Number
NCT01276067
Locations
🇺🇸

Novum Pharmaceutical Research Services, Pittsburgh,, Pennsylvania, United States

Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fed Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-01-13
Last Posted Date
2012-07-10
Lead Sponsor
Ranbaxy Laboratories Limited
Target Recruit Count
36
Registration Number
NCT01276080
Locations
🇺🇸

Novum Pharmaceutical Research Services, Las Vegas, Nevada, United States

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