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NCT07105709PHASE2Recruiting

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

GlaxoSmithKline

Start Date

8/14/2025

Completion Date

12/8/2028

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 Criteria

Age Range: 50 years to 85 years

Inclusion Criteria: * Completion of the Treatment Period in the parent study (NCT06079190). * Participants may have missed doses during the Treatment Period or may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study. * Willing and able to give informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). * Availability of an adult person who has frequent and sufficient contact with the participant, is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, and signs the study partner ICF. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of childbearing potential follows contraception requirements outlined in the protocol. * A male participant is eligible to participate if he follows contraception requirements outlined in the protocol. Exclusion Criteria: * QT interval corrected (QTc) assessment at Day 1 that meets the stopping criteria described in the protocol. * Participant is taking or will be starting a prohibited medication described in the protocol. * Evidence of any Amyloid related imaging abnormalities (ARIA) or cerebral macrohemorrhage that meets the permanent discontinuation criteria described in the protocol. * Other newly identified intracranial hemorrhage aneurysm, vascular malformation, infective lesion, space occupying lesion or brain tumor, or other Magnetic resonance imaging (MRI) findings contraindicating participation in the study. * Newly identified infection(s) that may affect the Central nervous system (CNS). * New diagnosis of moderate to severe alcohol and/or substance use disorder. * Change in participant's ability to tolerate MRI procedures, contraindication to MRI, or any other clinical history or examination finding that would pose a potential hazard in combination with MRI. * Newly diagnosed cancer. * Newly identified severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins. * Newly identified genetic predisposition for clotting disorder or hemorrhagic disease. * Any other clinically significant change in health status (which, in the opinion of the investigator, would make the participant unsuitable for participation in the OLE study.

Interventions

DRUG

GSK4527226

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Conditions

Alzheimer's Disease

Locations

GSK Investigational Site

Maitland, Florida 32752

United States

GSK Investigational Site

Miami, Florida 33176

United States

GSK Investigational Site

Stuart, Florida 34997

United States

GSK Investigational Site

Toms River, New Jersey 08755

United States

GSK Investigational Site

Staten Island, New York 10314

United States

GSK Investigational Site

Matthews, North Carolina 28105

United States

GSK Investigational Site

Oklahoma City, Oklahoma 73112

United States

GSK Investigational Site

Houston, Texas 77030

United States

GSK Investigational Site

Fairfax, Virginia 22031

United States

GSK Investigational Site

Buenos Aires, 1897

Argentina

GSK Investigational Site

Buenos Aires, C1425AGC

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1431FWO

Argentina

GSK Investigational Site

Ciudad Autonoma de Bueno, C1056ABJ

Argentina

GSK Investigational Site

Macquarie Park, New South Wales 2113

Australia

GSK Investigational Site

Nedlands, Western Australia 6009

Australia

GSK Investigational Site

Ottawa, Ontario K1Z 1G3

Canada

GSK Investigational Site

Peterborough, Ontario K9H 2P4

Canada

GSK Investigational Site

Toronto, Ontario M3B 2S7

Canada

GSK Investigational Site

Greenfield Park, Quebec J4V 2J2

Canada

GSK Investigational Site

Sherbrooke, Quebec J1J 2G2

Canada

GSK Investigational Site

Oulu, 90100

Finland

GSK Investigational Site

Bergen, 5009

Norway

GSK Investigational Site

Oslo, 0450

Norway

GSK Investigational Site

Junggu, 400711

South Korea

GSK Investigational Site

Barcelona, 08028

Spain

GSK Investigational Site

Gothenburg, 431 41

Sweden

GSK Investigational Site

Malmö, 21146

Sweden

GSK Investigational Site

Stockholm,

Sweden

GSK Investigational Site

Tainan, 704

Taiwan

GSK Investigational Site

Taoyuan, 333

Taiwan

GSK Investigational Site

Birmingham, B16 8LT

United Kingdom

GSK Investigational Site

Bristol, BS32 4SY

United Kingdom

GSK Investigational Site

London, W1G 8TA

United Kingdom