Open-label extension of GSK4527226 for people with early Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension enrolls participants who completed the parent randomized study (NCT06079190) and provides all enrolled participants with GSK4527226. The main goals are to collect longer-term safety data and to observe ongoing clinical effects in people with early Alzheimer's disease, including mild cognitive impairment and mild dementia due to AD. Participants must have completed the parent study without permanent early discontinuation and must have an available study partner to report on function and cognition. Study visits are conducted at designated GSK investigational sites in Florida.

Why it matters

Who can join: the full rules

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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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

Where it's running

• GSK Investigational Site
  Maitland, Florida, United States Recruiting
• GSK Investigational Site
  Miami, Florida, United States Recruiting
• GSK Investigational Site
  Stuart, Florida, United States Recruiting
• GSK Investigational Site
  Toms River, New Jersey, United States Recruiting
• GSK Investigational Site
  Staten Island, New York, United States Recruiting
• GSK Investigational Site
  Matthews, North Carolina, United States Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.