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New hope for early Alzheimer's? drug GSK4527226 tested for Long-Term safety

NCT ID NCT07105709

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is an extension of an earlier trial, testing the long-term safety and effectiveness of the drug GSK4527226 in people with early Alzheimer's disease (mild cognitive impairment or mild dementia). All 220 participants will receive the drug, and researchers will monitor for side effects like brain swelling or bleeding, as well as changes in memory and thinking over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GSK4527226 (AL101)
What this could lead to
If successful, this could show that GSK4527226 is safe and may help slow cognitive decline in early Alzheimer's disease.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results are less certain. The drug may cause brain swelling or bleeding (ARIA) and may not slow the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease brain disorder central nervous system disorder dementia nervous system disorder psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Maitland, Florida, 32752, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33176, United States

  • GSK Investigational Site

    RECRUITING

    Stuart, Florida, 34997, United States

  • GSK Investigational Site

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • GSK Investigational Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • GSK Investigational Site

    RECRUITING

    Matthews, North Carolina, 28105, United States

  • GSK Investigational Site

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, 1897, Argentina

  • GSK Investigational Site

    RECRUITING

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma de Buenos Aire, C1431FWO, Argentina

  • GSK Investigational Site

    RECRUITING

    Ciudad Autonoma de Bueno, C1056ABJ, Argentina

  • GSK Investigational Site

    RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • GSK Investigational Site

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • GSK Investigational Site

    RECRUITING

    Ottawa, Ontario, K1Z 1G3, Canada

  • GSK Investigational Site

    RECRUITING

    Peterborough, Ontario, K9H 2P4, Canada

  • GSK Investigational Site

    RECRUITING

    Toronto, Ontario, M3B 2S7, Canada

  • GSK Investigational Site

    RECRUITING

    Greenfield Park, Quebec, J4V 2J2, Canada

  • GSK Investigational Site

    RECRUITING

    Sherbrooke, Quebec, J1J 2G2, Canada

  • GSK Investigational Site

    RECRUITING

    Oulu, 90100, Finland

  • GSK Investigational Site

    RECRUITING

    Bergen, 5009, Norway

  • GSK Investigational Site

    RECRUITING

    Oslo, 0450, Norway

  • GSK Investigational Site

    RECRUITING

    Junggu, 400711, South Korea

  • GSK Investigational Site

    RECRUITING

    Barcelona, 08028, Spain

  • GSK Investigational Site

    RECRUITING

    Gothenburg, 431 41, Sweden

  • GSK Investigational Site

    RECRUITING

    Malmö, 21146, Sweden

  • GSK Investigational Site

    RECRUITING

    Stockholm, Sweden

  • GSK Investigational Site

    RECRUITING

    Tainan, 704, Taiwan

  • GSK Investigational Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • GSK Investigational Site

    RECRUITING

    Birmingham, B16 8LT, United Kingdom

  • GSK Investigational Site

    RECRUITING

    Bristol, BS32 4SY, United Kingdom

  • GSK Investigational Site

    RECRUITING

    London, W1G 8TA, United Kingdom

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