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Open-label extension of GSK4527226 for people 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

Phase 2 Interventional GlaxoSmithKline · NCT07105709

This extension gives GSK4527226 to people with early Alzheimer's disease who completed the parent study to see if the medicine stays safe and helps over the long term.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment220 (estimated)
Ages50 Years to 85 Years
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Locations33 sites (Maitland, Florida and 32 other locations)
Trial IDNCT07105709 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are people with early Alzheimer's disease (MCI or mild dementia) who completed the parent study treatment period, can provide informed consent, and have a study partner who can attend visits.

Not a fit: Patients who withdrew early or were permanently discontinued from the parent study, those with more advanced Alzheimer's disease, or those unable to meet safety or partner requirements (including pregnancy) are unlikely to benefit from joining this extension.

Why it matters

Potential benefit: If successful, continued treatment with GSK4527226 could stabilize or slow cognitive and functional decline in people with early Alzheimer's disease.

How similar studies have performed: Open-label extensions of other investigational Alzheimer's therapies have produced mixed results, with occasional safety and tolerability data but no consistent, definitive disease-modifying success to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Maitland, Florida and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer's DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMental Disorders
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.