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NCT05269394ACTIVE_NOT_RECRUITINGanonymous

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Sponsor

Source record

Washington University School of Medicine

Phase

Source record

Phase 2/3

Modality

AI-normalized

small molecule

Target

AI-normalized

Microtubule-associated protein tau (MAPT) and amyloid beta peptide.

Indication / condition

AI-normalized

Alzheimers Disease

Intervention

Source record

E2814, Lecanemab, Matching Placebo (E2814)

Source & freshness

Source record

NCT ID

NCT05269394

Original source

ClinicalTrials.gov

Source last updated

Feb 13, 2026

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT05269394

Title

A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

Sponsor

Washington University School of Medicine

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 2/3

Condition raw

Alzheimers Disease, Dementia, Alzheimers Disease, Familial

Condition normalized

Alzheimers Disease, Dementia, Alzheimers Disease, Familial

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Microtubule-associated protein tau (MAPT) and amyloid beta peptide.

Target normalized

Microtubule-associated protein tau (MAPT) and amyloid beta peptide.

Interventions

E2814, Lecanemab, Matching Placebo (E2814)

Public preview

Source record

The DIAN-TU trial, sponsored by Washington University School of Medicine, is a pivotal study investigating the efficacy of E2814, an anti-tau therapy, in combination with lecanemab, an investigational amyloid removal drug, for individuals with dominantly inherited Alzheimer's disease (DIAD). The trial targets a niche but critical segment of the Alzheimer's market, focusing on genetically predisposed patients. Given the increasing prevalence of Alzheimer's disease and the urgent need for effective disease-modifying therapies, successful outcomes could position the involved entities favorably in a competitive landscape characterized by high unmet medical need. The collaboration with Eisai Inc. and support from various NIH grants further enhances the credibility and potential market access of the investigational therapies. However, the trial's complexity and the stringent eligibility criteria may limit patient recruitment and generalizability of results.

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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