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
- -
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
- Conditions
- Interventions
- First Posted Date
- 2010-12-24
- Last Posted Date
- 2016-03-14
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 291
- Registration Number
- NCT01266525
- Locations
- 🇺🇸
Investigational Site Number 840024, Costa Mesa, California, United States
🇺🇸Investigational Site Number 840041, Gilbert, Arizona, United States
🇵🇱Investigational Site Number 616004, Bydgoszcz, Poland
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
- First Posted Date
- 2010-12-15
- Last Posted Date
- 2011-02-21
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 26
- Registration Number
- NCT01260922
- Locations
- 🇺🇸
PRACS Institute, Ltd., East Grand Forks, Minnesota, United States
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Non-Fasting Conditions
- First Posted Date
- 2010-12-15
- Last Posted Date
- 2011-02-21
- Lead Sponsor
- Teva Pharmaceuticals USA
- Target Recruit Count
- 26
- Registration Number
- NCT01260948
- Locations
- 🇺🇸
PRACS Institute, Ltd., East Grand Forks, Minnesota, United States
Post-marketing Surveillance of Donepezil Hydrochloride -Investigation of the Clinical Safety and Effectiveness in Patients With Alzheimer's Disease
- First Posted Date
- 2010-12-02
- Last Posted Date
- 2023-07-24
- Lead Sponsor
- Eisai Co., Ltd.
- Target Recruit Count
- 894
- Registration Number
- NCT01251718
Effect of Donepezil on Smoking
- First Posted Date
- 2010-12-01
- Last Posted Date
- 2019-07-11
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Target Recruit Count
- 30
- Registration Number
- NCT01250977
- Locations
- 🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
An Efficacy and Safety Study of INM-176 for the Treatment of Patients With Alzheimer Type Dementia
- First Posted Date
- 2010-11-22
- Last Posted Date
- 2011-06-13
- Lead Sponsor
- Whanin Pharmaceutical Company
- Target Recruit Count
- 280
- Registration Number
- NCT01245530
- Locations
- 🇰🇷
Whanin Pharm.Co.,Ltd., Seoul, Moonjung, Korea, Republic of
Scopolamine Challenge Study
- Conditions
- Interventions
- First Posted Date
- 2010-10-04
- Last Posted Date
- 2018-11-14
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 38
- Registration Number
- NCT01213355
- Locations
- 🇫🇷
Pfizer Investigational Site, Rennes, France
Evaluation of Three Potential Central Nervous System (CNS) Pretreatments for Soman Exposure on Human Performance
- Conditions
- Interventions
- First Posted Date
- 2010-09-03
- Last Posted Date
- 2017-05-03
- Target Recruit Count
- 84
- Registration Number
- NCT01194336
- Locations
- 🇺🇸
Walter Reed Army Institute of Research, Silver Spring, Maryland, United States
Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
- First Posted Date
- 2010-06-04
- Last Posted Date
- 2013-01-29
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- Target Recruit Count
- 267
- Registration Number
- NCT01137526
- Locations
- 🇿🇦
Site Reference ID/Investigator# 45584, Belville, South Africa
🇷🇺Site Reference ID/Investigator# 37944, Moscow, Russian Federation
🇬🇧Site Reference ID/Investigator# 36327, Bath, United Kingdom
Post-marketing Surveillance of Long-term Administration of Donepezil Hydrochloride -Investigation of the Clinical Condition and Safety in Patients With Alzheimer's Disease-
- First Posted Date
- 2010-05-24
- Last Posted Date
- 2018-11-05
- Lead Sponsor
- Eisai Co., Ltd.
- Target Recruit Count
- 10238
- Registration Number
- NCT01129596
Drug Development Updates
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