A Phase 2, Parallel Group, Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared with Placebo in Patients with Early Alzheimer’s Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505083-11-01

Acronym

219867

Enrollment

140

Registered

2024-03-05

Start date

2024-05-07

Completion date

Unknown

Last updated

2025-12-04

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

Change from baseline in CDR-SB across Weeks 52, 64 and 76.

Detailed description

Change from baseline across Weeks 52, 64 and 76 in: • iADRS • ADAS-Cog14 • ADCS-iADL component of ADCS-ADL-MCI • ADCS-ADL-MCI • ADCOMS

Interventions

DRUG0.9% (w/v) sodium chloride (Normal Saline)

DRUGNeuraceq 300 MBq/mL solution for injection

DRUGAmyvid 800 MBq/mL solution for injection

DRUGVIZAMYL 400 MBq/mL solution for injection

DRUGAmyvid 1900 MBq/mL solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in CDR-SB across Weeks 52, 64 and 76.	—

Secondary

Measure	Time frame
Change from baseline across Weeks 52, 64 and 76 in: • iADRS • ADAS-Cog14 • ADCS-iADL component of ADCS-ADL-MCI • ADCS-ADL-MCI • ADCOMS	—

Countries

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

Outcome results

None listed

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