RecruitingPhase 2NCT07105709

Open-label Extension Study in Participants With Early Alzheimer's Disease

A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 (AL101) in Participants With Early Alzheimer's Disease


Sponsor

GlaxoSmithKline

Enrollment

220 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study medicine GSK4527226 is being studied in participants with Alzheimer's Disease (AD) in study 219867 (the parent study, NCT06079190). This new study is an extension of that parent study called an open-label extension (OLE). An OLE is a clinical trial where all participants receive the same study medicine. Participants must already be in study 219867 to be able to take part in this study. This study will assess the long-term safety and efficacy of GSK4527226 in participants with early AD (including mild cognitive impairment \[MCI\] and mild dementia due to AD) who have completed the parent study.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This open-label extension study is offering continued access to an investigational Alzheimer's disease treatment for participants who already completed a related clinical trial, so researchers can study its long-term effects. **You may be eligible if...** - You already completed the treatment period of a specific parent Alzheimer's trial (NCT06079190) - You are willing and able to continue receiving the study drug and attending follow-up visits - You have a study partner (a family member or close contact) who can accompany you and report on your cognitive and daily functioning **You may NOT be eligible if...** - You were permanently discontinued from the parent study or withdrew early - You or your study partner are unable to meet the study requirements - Female participants who are pregnant, breastfeeding, or not using effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGSK4527226

GSK4527226 will be administered.


Locations(33)

GSK Investigational Site

Maitland, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Stuart, Florida, United States

GSK Investigational Site

Toms River, New Jersey, United States

GSK Investigational Site

Staten Island, New York, United States

GSK Investigational Site

Matthews, North Carolina, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Fairfax, Virginia, United States

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, Argentina

GSK Investigational Site

Macquarie Park, New South Wales, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Peterborough, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Greenfield Park, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

GSK Investigational Site

Oulu, Finland

GSK Investigational Site

Bergen, Norway

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Junggu, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Gothenburg, Sweden

GSK Investigational Site

Malmö, Sweden

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Tainan, Taiwan

GSK Investigational Site

Taoyuan, Taiwan

GSK Investigational Site

Birmingham, United Kingdom

GSK Investigational Site

Bristol, United Kingdom

GSK Investigational Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07105709


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