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Looking for participantsPhase2

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

Sponsor: GlaxoSmithKline

NCT ID: NCT07105709

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
GSK4527226 (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
GSK4527226 — drug: GSK4527226 will be administered.
Patient visit burden
Not specified by the sponsor

In plain English

This is an extension study for people with early Alzheimer's disease who took part in an earlier study (NCT06079190). It is 'open-label', which means everyone knows what treatment they are receiving. It is run by GlaxoSmithKline.

Who can take part

  • You finished the treatment period of the earlier study (NCT06079190).
  • You may have missed some doses or paused your dose, but you must not have stopped the treatment for good or left the earlier study.
  • You are willing and able to give your agreement (consent) to take part and follow the study rules.
  • You have an adult (a 'study partner') who sees you often, can give accurate information about your memory and daily abilities, comes to clinic visits, and signs their own agreement form.
  • If you are a woman who could become pregnant, you must not be pregnant or breastfeeding and must follow the study's contraception rules.
  • If you are a man, you must follow the study's contraception rules.

Who may not be able to

  • A heart tracing (QTc) result on day 1 that meets the study's stopping rules.
  • Taking or starting a medicine the study does not allow.
  • Signs of swelling or bleeding in the brain linked to amyloid (ARIA) or other serious brain bleeding that means treatment must be stopped for good.
  • Newly found problems in the brain on a scan, such as a bleed, aneurysm, abnormal blood vessel, infection, growth or tumour, or other scan findings that rule out taking part.
  • A new infection that might affect the brain or nervous system.
  • A new diagnosis of moderate to severe alcohol or drug (substance) use disorder.
  • You can no longer tolerate MRI scans, MRI scans are unsafe for you, or anything else that makes MRI scans risky for you.
  • A new diagnosis of cancer.
  • A new serious allergic reaction (such as anaphylaxis) to antibody or fusion protein medicines.
  • A newly found genetic tendency towards blood clotting or bleeding problems.
  • Any other significant change in your health that, in the study doctor's view, makes you unsuitable to take part.

What taking part involves

  • • Not stated — ask the trial team.
  • • You will keep taking the study treatment from the earlier study (type of treatment is not stated — ask the trial team).

Time commitment: Not stated — ask the trial team (details of clinic visits, how long the study lasts, and what taking part involves are not given).

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
50 Years to 85 Years
Who
All
Number of participants
220
Started
2025-08-14
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for alzheimer's disease
  • • Phase2 - 220 participants
  • • The study medicine GSK4527226 is being studied in participants with Alzheimer's Disease (AD) in study 219867 (the parent study, NCT06079190)

Who can take part?

  • • Ages 50 Years to 85 Years
  • • Diagnosed with alzheimer's disease

Where?

  • • Birmingham - GSK Investigational Site
  • • Bristol - GSK Investigational Site
  • • London - GSK Investigational Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Alzheimer's Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 85 Years
  • Who can join: All genders

Biomarkers mentioned

antibodies or fusion

What the study is looking for

  • ✓Completion of the Treatment Period in the parent study (NCT06079190).
  • ✓Willing and able to give agreement to take part, which includes compliance with the requirements and restrictions listed...
  • ✓A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of childbearing...
  • ✓A male participant is eligible to participate if he follows contraception requirements outlined in the protocol.

Who cannot take part

  • ✗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...
  • ✗Newly identified infection(s) that may affect the Central nervous system (CNS).
  • ✗New diagnosis of moderate to severe alcohol and/or substance use disorder.
See the full 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 Is This Study? (3 UK sites)

GSK Investigational Site

Birmingham B16 8LT, United Kingdom

Recruiting
Site contact (verified)
Terence McLoughlinPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Bristol BS32 4SY, United Kingdom

Recruiting
Site contact (verified)
Daniel LashleyPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

London W1G 8TA, United Kingdom

Recruiting
Site contact (verified)
Emer MacSweeneyPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01