Recruiting

Phase 2

GSK4527226Open-label Extension Study in Participants With Early Alzheimer's Disease

Sponsor:

GlaxoSmithKline

Code:

NCT07105709

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

GSK4527226

Study Details

Brief 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.

Conditions

Alzheimer's Disease

Study ID

NCT07105709

Start date

Aug 14, 2025

Status verified date

Jan, 2026

Completion date

Dec 8, 2028

Anticipated

Primary completion date

Sep 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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.

Study Design

Enrollment

220 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GSK4527226

Participants will receive GSK4527226.

Interventions

GSK4527226

GSK4527226 will be administered.

Primary outcome measure

Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE [ Time Frame: Up to 112 Weeks ]
Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE [ Time Frame: Up to 112 Weeks ]
Number of Participants with Serious Adverse Events (SAEs) during the OLE [ Time Frame: Up to 112 Weeks ]
Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE [ Time Frame: Up to 112 Weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Maitland, Florida, United States, 32752

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sheila Baez-Torres

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33176

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ramon Leon

GSK Investigational Site

Recruiting

Stuart, Florida, United States, 34997

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Paayal Patel

GSK Investigational Site

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Arun Singh

GSK Investigational Site

Recruiting

Staten Island, New York, United States, 10314

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Adam Smith

GSK Investigational Site

Recruiting

Matthews, North Carolina, United States, 28105

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mohammed Bolouri

GSK Investigational Site

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Carl Griffin

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77030

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Claudia Perez

GSK Investigational Site

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Raymond Turner

GSK Investigational Site

Recruiting

Ottawa, Ontario, Canada, K1Z 1G3

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Richard Bergeron

GSK Investigational Site

Recruiting

Peterborough, Ontario, Canada, K9H 2P4

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sarah Brisbin

GSK Investigational Site

Recruiting

Toronto, Ontario, Canada, M3B 2S7

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sharon Cohen

GSK Investigational Site

Recruiting

Greenfield Park, Quebec, Canada, J4V 2J2

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ziad Nasreddine

GSK Investigational Site

Recruiting

Sherbrooke, Quebec, Canada, J1J 2G2

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Paule Royer

More Information

Sponsor

GlaxoSmithKline

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

Alzheimer's Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-02-02.