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NCT01276353COMPLETEDanonymous

A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

Sponsor

Source record

Eisai Inc.

Phase

Source record

Phase 2

Modality

AI-normalized

small molecule

Target

AI-normalized

Acetylcholinesterase (AChE) inhibition via donepezil, a reversible inhibitor of the enzyme, enhancing cholinergic neurotransmission.

Indication / condition

AI-normalized

Alzheimer's Type Dementia

Intervention

Source record

E2020, E2020

Source & freshness

Source record

NCT ID

NCT01276353

Original source

ClinicalTrials.gov

Source last updated

Aug 08, 2014

Ingested at

Jun 17, 2026

Internal sync

Jun 17, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT01276353

Title

A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

Sponsor

Eisai Inc.

Status

COMPLETED

Phase

Phase 2

Condition raw

Alzheimer's Type Dementia

Condition normalized

Alzheimer's Type Dementia

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Acetylcholinesterase (AChE) inhibition via donepezil, a reversible inhibitor of the enzyme, enhancing cholinergic neurotransmission.

Target normalized

Acetylcholinesterase (AChE) inhibition via donepezil, a reversible inhibitor of the enzyme, enhancing cholinergic neurotransmission.

Interventions

E2020, E2020

Public preview

Source record

Eisai Inc.'s study evaluates a sustained release formulation of donepezil (E2020 SR 23 mg) against the established immediate release formulation (E2020 10 mg) in severe Alzheimer's disease patients. The trial's completion and subsequent data analysis could provide insights into improved dosing regimens and patient adherence, potentially expanding market share in the Alzheimer's treatment landscape. Given the increasing prevalence of Alzheimer's disease, successful outcomes may enhance Eisai's competitive positioning against other cholinesterase inhibitors and emerging therapies. The study's focus on a Japanese population may also provide localized data that could influence regional market strategies.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 17, 2026

NCT ID

NCT01276353

Status

COMPLETED

Phase

Phase 2

Sponsor

Eisai Inc.

Executive brief

Investment-Ready Snapshot

Eisai Inc.'s study evaluates a sustained release formulation of donepezil (E2020 SR 23 mg) against the established immediate release formulation (E2020 10 mg) in severe Alzheimer's disease patients. The trial's completion and subsequent data analysis could provide insights into improved dosing regimens and patient adherence, potentially expanding market share in the Alzheimer's treatment landscape. Given the increasing prevalence of Alzheimer's disease, successful outcomes may enhance Eisai's competitive positioning against other cholinesterase inhibitors and emerging therapies. The study's focus on a Japanese population may also provide localized data that could influence regional market strategies.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedAug 08, 2014
Internal syncJun 17, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT01276353

Indication

Alzheimer's Type Dementia

Modality

small molecule

Target

Acetylcholinesterase (AChE) inhibition via donepezil, a reversible inhibitor of the enzyme, 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.