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Clinical trial intelligence report
Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 25, 2026
Report code
NCT01539031-Jun 25, 2026
NCT ID
NCT01539031
Status
COMPLETED
Phase
Phase 3
Sponsor
Eisai Co., Ltd.
Executive brief
Investment-Ready Snapshot
Eisai Co., Ltd. is conducting a Phase 3 clinical trial comparing the efficacy and safety of a higher dose (23 mg) of Donepezil Hydrochloride to the standard 10 mg dose in Japanese patients with severe Alzheimer's disease. The market for Alzheimer's treatments is significant, with increasing prevalence in aging populations. The trial's completion in March 2015 positions Eisai to potentially expand its market share in the cholinesterase inhibitor segment, particularly in Japan, where the demand for effective Alzheimer's therapies is high. Competitive implications include the need to differentiate from existing treatments and address the limitations of current therapies, which may enhance Eisai's strategic positioning in the neurodegenerative disease market.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT01539031
Indication
Alzheimer's Type Dementia
Modality
small molecule
Target
Acetylcholinesterase inhibition via Donepezil Hydrochloride, a reversible inhibitor of the enzyme acetylcholinesterase, enhancing cholinergic neurotransmission.
Intervention
E2020, E2020
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.