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AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel Treatment Arm, 216 Week Study with an Extension Phase to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510888-39-00
Acronym
BAN2401-G000-303
Enrollment
20
Registered
2024-06-06
Start date
2021-07-21
Completion date
Unknown
Last updated
2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preclinical Alzheimer’s Disease and Elevated Amyloid, Early Preclinical Alzheimer’s Disease and Intermediate Amyloid

Brief summary

A45 Trial: Change from baseline in PACC5 at 216 weeks., A3 Trial: Change from baseline in amyloid PET SUVr at 216 weeks.

Detailed description

A45 Trial: Change from baseline in amyloid PET SUVr at 96 and 216 weeks, A45 Trial: Change from baseline in tau PET SUVr at 96 and 216 weeks, A45 Trial: Change from baseline in CFI at 216 weeks, A3 Trial: Change from baseline in tau PET SUVr at 216 weeks

Interventions

Sponsors

Eisai Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
A45 Trial: Change from baseline in PACC5 at 216 weeks., A3 Trial: Change from baseline in amyloid PET SUVr at 216 weeks.

Secondary

MeasureTime frame
A45 Trial: Change from baseline in amyloid PET SUVr at 96 and 216 weeks, A45 Trial: Change from baseline in tau PET SUVr at 96 and 216 weeks, A45 Trial: Change from baseline in CFI at 216 weeks, A3 Trial: Change from baseline in tau PET SUVr at 216 weeks

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026