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Donepezil

Phase 1

Alzheimer's Disease | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Feb 8, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment155

FDA Designations

No designations recorded

Clinical trial landscape

Donepezil · 1 trial · 1 indication

Early Phase 1 1
NCT01024660The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With DonepezilAlzheimer's Disease
COMPLETED155 Analytics
EARLY_PHASE1COMPLETED
The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

CogState Computerized Neurological Test Battery
Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98

Secondary Endpoints

Neuropsychological Test Battery (NTB)
Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)
Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
DonepezilDRUG5 mg capsule, orally, once daily, first 14 days of treatment
Placebo to match AriceptDRUGPlacebo capsule, orally, 84 days of treatment
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Eligibility Criteria

Age Range55 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria. * The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patien...

Countries:CanadaPeruPolandSouth Africa
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Frequently asked questions about Donepezil

What is Donepezil used for?

Donepezil is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is currently in early Phase 1 clinical development, with one completed trial evaluating its effects on cognitive function after 12 weeks of treatment.

Who makes Donepezil?

Donepezil is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the drug's potential in treating Alzheimer's Disease.

What phase is Donepezil in?

Donepezil is in early Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One early Phase 1 trial has been completed, and the drug remains under clinical investigation for Alzheimer's Disease.

What clinical trials is Donepezil in?

Donepezil has one completed clinical trial registered under NCT01024660, titled 'The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil.' This early Phase 1 study enrolled 155 participants with Alzheimer's Disease across Canada, Peru, Poland, and South Africa.

Is Donepezil the same as Aricept?

Donepezil is the generic name for the medication also known as Aricept. The drug is being studied by AstraZeneca for Alzheimer's Disease, and the completed clinical trial NCT01024660 evaluated its effects on cognitive function in patients with this condition.