A Multi-Center, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 [AL101] in Participants with Early Alzheimer’s Disease.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521107-42-00

Acronym

223646

Enrollment

143

Registered

2025-10-23

Start date

2025-11-25

Completion date

Unknown

Last updated

2025-11-10

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

Conditions

Alzheimer's Disease

Brief summary

Incidence of treatment emergent AEs, including AESIs and SAEs, during the OLE, Incidence and severity of ARIAs during the OLE

Detailed description

Change from OLE baseline1 during the OLE in cognitive assessments: • CDR-SB • ADAS-Cog14 • MMSE • ADCS-ADL-MCI • iADRS • ADCOMS

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of treatment emergent AEs, including AESIs and SAEs, during the OLE, Incidence and severity of ARIAs during the OLE	—

Secondary

Measure	Time frame
Change from OLE baseline1 during the OLE in cognitive assessments: • CDR-SB • ADAS-Cog14 • MMSE • ADCS-ADL-MCI • iADRS • ADCOMS	—

Countries

Finland, France, Germany, Italy, Netherlands, Norway, Spain, Sweden

Outcome results