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New drug aims to slow Alzheimer's in early stages

NCT ID NCT06079190

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 2 times

Summary

This study tests an experimental drug called GSK4527226 in 367 people with early Alzheimer's (mild memory problems or mild dementia). Participants receive either a low dose, high dose, or placebo through an IV. The goal is to see if the drug can slow down declines in memory and daily function over about 18 months.

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

367 people

The number who actually took part.

Started

Oct 2023

Finished

Aug 2026

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: Participant must be in the Alzheimer's continuum as defined by the 2018 National Institute on Aging and Alzheimer's Association (NIAAA) Research Framework corresponding to the clinical categories of MCI due to AD and mild AD dementia. Participant must have evidence of amyloid positivity either by positive positron emission tomography (PET) result (Amyloid PET scans must be read by a central imaging lab) or cerebrospinal fluid (CSF) amyloid beta (Aβ) test result indicative of amyloid positivity * Participants must also meet the following criteria for clinical severity: 1. MMSE score of between 21 and 29 points 2. CDR-global score (GS) of 0.5 to 1.0. 3. CDR Memory Box score greater than or equal to (≥) 0.5. 4. Participants with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale-IV Logical Memory II (WMS-IV LMII) * If the participant is receiving symptomatic AD medications such as an Acetylcholinesterase inhibitor (AChEI) or memantine, the dosing regimen must have been stable for at least 12 weeks prior to screening and is not expected to change during study participation. * If the participant is receiving other medications for AD related symptoms or associated conditions, the dosing regimen must have been stable for at least 4 weeks prior to screening and not expected to change during study participation. Symptoms must be considered adequately and stably controlled by the investigator, without marked changes in medication anticipated for the duration of the study. * Body weight ≥ 45 kilogram (kg) to less than or equal to (≤)120 kg with body mass index (BMI) between 17 and 34.9 kilogram per meter square (kg/m\^2), inclusive. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of child-bearing potential follows contraception requirements outlined in the protocol * A male participant is eligible to participate if he follows contraception requirements outlined in the protocol * 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 ICF of the study partner. Exclusion Criteria: Participant has evidence of any neurological condition other than AD that may contribute to cognitive impairment. * History or presence of vascular disease that has the potential to affect cognitive function. * History or presence of stroke within the past 1 year or recent transient ischemic attack within 180 days before screening. * History of severe, clinically significant central nervous system (CNS) trauma. * History or presence of intracranial tumor. * Presence of ongoing infection(s) that may affect brain function, or history of infections that resulted in neurologic sequelae. * History of primary psychiatric diagnosis that the investigator considers may interfere with study assessments. Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, suicidal behaviour or has been assessed to be at risk of suicide, in the opinion of the investigator within 6 months before screening, at screening, or at the Baseline visit, or has been hospitalized or treated for suicidal behaviour in the past 2 years. * Participant has history of alcohol and/or moderate to severe substance use disorder within the past 2 years * Magnetic resonance imaging (MRI) evidence based on central read of: 1. \>3 lacunar infarcts. 2. Stroke involving a major vascular territory, severe small vessel, or white matter disease. 3. Any territorial /cortical/other infarct \>1 cubic centimetre (cm\^3). 4. White matter hyperintense lesions on the FLAIR sequence that correspond to an overall Fazekas score of 3 5. \>4 microhaemorrhages. 6. Any areas of superficial (leptomeningeal) hemosiderosis. 7. A single macro-hemorrhage greater than 10 millimetres (mm) at greatest diameter. 8. Vasogenic edema. 9. Cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions. 10. Space occupying lesions or brain tumors. 11. Significant cerebral vascular pathology 12. Hydrocephalus/Normal pressure hydrocephalus. 13. Other MRI findings contraindicating participation in the study such as subarachnoid hemorrhage. * History suggestive of exposure to, or past tuberculosis (TB) infection should undergo screening for TB disease. * Chronic active immune disorder requiring systemic immunosuppressive therapy within 6 months prior to Screening. * Screening serum vitamin B12 concentration \< Lower limit of normal (LLN) or in the low normal range * Folate \<LLN or Thyroid-stimulating hormone (TSH) \> Upper limit of normal (ULN) * Hemoglobin A1c \>8 percentage (%) or poorly controlled diabetes during the last 12 weeks * History of cancer * Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins * Planned surgery during the study which requires general, spinal, or epidural anesthesia that would take place during the study. * Known genetic predisposition for clotting disorder or hemorrhagic disease. * Key exclusionary medications include: * Antipsychotics, opiates/opioids, cannabinoids, hypnotics, antidepressants, mood stabilizers, or stimulants that are used on a chronic basis, are exclusionary if not consistent with the following rule: treatment has to have been at a stable dose for at least 4 weeks before screening and should remain stable during the study * Any biologic drugs with systemic exposure, whether investigational or approved, used within 6 months before screening Any disease modification drug for AD, such as aducanumab and lecanemab, whether investigational or approved, used within 6 months before screening. * Anticoagulation medications within 90 days of screening and during the study * Systemic immunosuppressive therapy within 6 months before screening and during the 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

Contacts and locations

Locations

  • GSK Investigational Site

    San Diego, California, 92103, United States

  • GSK Investigational Site

    Lake Mary, Florida, 32720, United States

  • GSK Investigational Site

    Lake Worth, Florida, 33462, United States

  • GSK Investigational Site

    Maitland, Florida, 32752, United States

  • GSK Investigational Site

    Miami, Florida, 33176-7947, United States

  • GSK Investigational Site

    Orlando, Florida, 32803, United States

  • GSK Investigational Site

    Orlando, Florida, 32804, United States

  • GSK Investigational Site

    Stuart, Florida, 34997, United States

  • GSK Investigational Site

    The Villages, Florida, 32159, United States

  • GSK Investigational Site

    The Villages, Florida, 32162, United States

  • GSK Investigational Site

    Decatur, Georgia, 30030, United States

  • GSK Investigational Site

    Elk Grove Village, Illinois, 60007, United States

  • GSK Investigational Site

    Chesterfield, Missouri, 63005, United States

  • GSK Investigational Site

    Toms River, New Jersey, 08755-5043, United States

  • GSK Investigational Site

    Staten Island, New York, 10314, United States

  • GSK Investigational Site

    Matthews, North Carolina, 28105-8335, United States

  • GSK Investigational Site

    North Canton, Ohio, 44720, United States

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112, United States

  • GSK Investigational Site

    Portland, Oregon, 97210-5311, United States

  • GSK Investigational Site

    Houston, Texas, 77030-1312, United States

  • GSK Investigational Site

    Fairfax, Virginia, 22031, United States

  • GSK Investigational Site

    Buenos Aires, C1425AGC, Argentina

  • GSK Investigational Site

    Buenos Aires, C1428AQK, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1431FWO, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1056ABJ, Argentina

  • GSK Investigational Site

    Camperdown, New South Wales, 2050, Australia

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010, Australia

  • GSK Investigational Site

    Kogarah, New South Wales, 2217, Australia

  • GSK Investigational Site

    Macquarie Park, New South Wales, 2113, Australia

  • GSK Investigational Site

    Gold Coast, Queensland, 4222, Australia

  • GSK Investigational Site

    Heidelberg, Victoria, 3079, Australia

  • GSK Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • GSK Investigational Site

    Melbourne, Australia

  • GSK Investigational Site

    Ottawa, Ontario, K1Z 1G3, Canada

  • GSK Investigational Site

    Peterborough, Ontario, K9H 2P4, Canada

  • GSK Investigational Site

    Toronto, Ontario, M3B 2S7, Canada

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2J2, Canada

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2, Canada

  • GSK Investigational Site

    Helsinki, 00180, Finland

  • GSK Investigational Site

    Kuopio, 70210, Finland

  • GSK Investigational Site

    Oulu, 90100, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Bron, 69500, France

  • GSK Investigational Site

    Lille, 59037, France

  • GSK Investigational Site

    Nice, 06100, France

  • GSK Investigational Site

    Paris, 75010, France

  • GSK Investigational Site

    Paris, 75013, France

  • GSK Investigational Site

    Saint-Herblain, 44093, France

  • GSK Investigational Site

    Strasbourg, 67000, France

  • GSK Investigational Site

    Toulouse, 31300, France

  • GSK Investigational Site

    Villeurbanne, 69100, France

  • GSK Investigational Site

    Erbach im Odenwald, Hesse, 64711, Germany

  • GSK Investigational Site

    Cologne, 50935, Germany

  • GSK Investigational Site

    München, 80336, Germany

  • GSK Investigational Site

    Münster, 48149, Germany

  • GSK Investigational Site

    Brescia, 25123, Italy

  • GSK Investigational Site

    CefalU PA, 90015, Italy

  • GSK Investigational Site

    Genova, 16132, Italy

  • GSK Investigational Site

    Milan, 20132, Italy

  • GSK Investigational Site

    Milan, 20133, Italy

  • GSK Investigational Site

    Modena, 41126, Italy

  • GSK Investigational Site

    Monza, 20900, Italy

  • GSK Investigational Site

    Pavia, 27100, Italy

  • GSK Investigational Site

    Perugia, 06129, Italy

  • GSK Investigational Site

    's-Hertogenbosch, North Brabant, 5223 LA, Netherlands

  • GSK Investigational Site

    Amsterdam, North Holland, 1081 GN, Netherlands

  • GSK Investigational Site

    Zwolle, Overijssel, 8025 AZ, Netherlands

  • GSK Investigational Site

    Bergen, 5009, Norway

  • GSK Investigational Site

    Oslo, 0450, Norway

  • GSK Investigational Site

    Stavanger, Norway

  • GSK Investigational Site

    Junggu, 400711, South Korea

  • GSK Investigational Site

    Seoul, 04763, South Korea

  • GSK Investigational Site

    Seoul, 138-736, South Korea

  • GSK Investigational Site

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • GSK Investigational Site

    Getxo, Vizcaya, 48993, Spain

  • GSK Investigational Site

    Barcelona, 08028, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Pamplona, 31008, Spain

  • GSK Investigational Site

    Salamanca, 37007, Spain

  • GSK Investigational Site

    Terrassa - Barcelona, 08221, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Gothenburg, 431 41, Sweden

  • GSK Investigational Site

    Malmö, 21146, Sweden

  • GSK Investigational Site

    Stockholm, Sweden

  • GSK Investigational Site

    Kaohsiung City, 833, Taiwan

  • GSK Investigational Site

    Tainan, 704, Taiwan

  • GSK Investigational Site

    Tau-Yuan, 333, Taiwan

  • GSK Investigational Site

    Ankara, 06230, Turkey (Türkiye)

  • GSK Investigational Site

    CapaIstanbul, 34093, Turkey (Türkiye)

  • GSK Investigational Site

    Birmingham, B16 8LT, United Kingdom

  • GSK Investigational Site

    Bristol, BS32 4SY, United Kingdom

  • GSK Investigational Site

    Glasgow, ML1 4UF, United Kingdom

  • GSK Investigational Site

    London, EC2Y 8EA, United Kingdom

  • GSK Investigational Site

    London, W1G 8TA, United Kingdom

  • GSK Investigational Site

    London, WC1N 3BG, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.