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donepezil

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Last Updated: Nov 19, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment438

FDA Designations

No designations recorded

Clinical trial landscape

donepezil · 1 trial · 1 indication

Phase 2 1
NCT01527916Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED438 Analytics
PHASE2COMPLETED
Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Alzheimer's Disease Assessment Scale - cognitive subscale
Measurements up through 24 weeks

Secondary Endpoints

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Measurements up through 24 weeks
Mini Mental Status Exam (MMSE)
Measurements up through 24 weeks
DEMentia Quality of Life (DEMQOL)
Measurements up through 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
sugar pillPLACEBO_COMPARATOR -
donepezilACTIVE_COMPARATOR -
ABT-126 Low DoseEXPERIMENTALlow dose
ABT-126 Middle DoseEXPERIMENTALmiddle dose
ABT-126 high doseEXPERIMENTALhigh dose

Interventions

NameTypeDescription
placeboDRUGPlacebo Comparator
donepezilDRUGActive Comparator
ABT-126DRUGlow dose, middle dose, high dose
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Eligibility Criteria

Age Range55 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject. * The sub...

Countries:United StatesPolandRussiaSouth AfricaUkraineUnited Kingdom
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Frequently asked questions about donepezil

What is donepezil used for in Alzheimer's Disease?

Donepezil is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is currently in Phase 2 clinical development, having completed a trial in patients with mild to moderate Alzheimer's Disease. The drug is being developed by AbbVie Inc. and is not yet approved for this use.

What does donepezil target?

The specific molecular target of donepezil is not disclosed in the available information. The drug is a small molecule being evaluated for its efficacy and safety in patients with mild to moderate Alzheimer's Disease. Its mechanism of action has not been publicly detailed in the context of this development program.

Who makes donepezil?

Donepezil is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's potential in treating Alzheimer's Disease, with the most recent study having been completed.

What phase is donepezil in?

Donepezil is in Phase 2 clinical development for Alzheimer's Disease. A Phase 2 trial has been completed, involving 438 participants with mild to moderate Alzheimer's Disease. The drug remains investigational and has not received regulatory approval for any indication.

What clinical trials is donepezil in?

Donepezil has been studied in one completed Phase 2 clinical trial, identified as NCT01527916. This randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of the drug in 438 subjects with mild to moderate Alzheimer's Disease across multiple countries, including the United States, Poland, Russia, South Africa, Ukraine, and the United Kingdom.

Is donepezil the same as ABT-126?

Yes, donepezil is the same as ABT-126. The Phase 2 clinical trial NCT01527916, which evaluated the drug in subjects with mild to moderate Alzheimer's Disease, was titled 'Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease.' This confirms that ABT-126 is the investigational name for donepezil.