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

January 30, 2026 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jose Crespo
      • Buenos Aires, Argentina, 1897
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ricardo Francisco Allegri
      • Ciudad Autonoma de Bueno, Argentina, C1056ABJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Griselda Russo
      • Ciudad Autonoma de Buenos Aire, Argentina, C1431FWO
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diego Castro
  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosalyn Lai
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Clarke
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Z 1G3
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Bergeron
        • Contact:
        • Contact:
      • Peterborough, Ontario, Canada, K9H 2P4
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sarah Brisbin
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M3B 2S7
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sharon Cohen
        • Contact:
        • Contact:
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ziad Nasreddine
        • Contact:
        • Contact:
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paule Royer
  • Finland
      • Oulu, Finland, 90100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hanna Ansakorpi
  • Norway
      • Bergen, Norway, 5009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ragnhild Eide Skogseth
      • Oslo, Norway, 0450
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne-Brita Knapskog
  • South Korea
      • Junggu, South Korea, 400711
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seong Hye Choi
  • Spain
      • Barcelona, Spain, 08028
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Merce Boada
        • Contact:
        • Contact:
  • Sweden
      • Gothenburg, Sweden, 431 41
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Jonsson
      • Malmo, Sweden, 21146
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henrik Ostlund
      • Stockholm, Sweden
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pia Andersen
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ming-Chyi Pai
      • Taoyuan District, Taiwan, 333
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chin-Chang Huang
  • United Kingdom
      • Birmingham, United Kingdom, B16 8LT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Terence McLoughlin
      • Bristol, United Kingdom, BS32 4SY
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Daniel Lashley
      • London, United Kingdom, W1G 8TA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emer MacSweeney
  • United States
    • Florida
      • Maitland, Florida, United States, 32752
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sheila Baez-Torres
      • Miami, Florida, United States, 33176
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ramon Leon
        • Contact:
        • Contact:
      • Stuart, Florida, United States, 34997
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paayal Patel
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Arun Singh
        • Contact:
        • Contact:
    • New York
      • Staten Island, New York, United States, 10314
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam Smith
    • North Carolina
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammed Bolouri
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Carl Griffin
        • Contact:
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudia Perez
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raymond Turner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GSK4527226
Participants will receive GSK4527226.
Drug: GSK4527226
GSK4527226 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE
Time Frame: Up to 112 Weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Up to 112 Weeks
Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE
Time Frame: Up to 112 Weeks
AESIs includes Infusion-related reactions, Amyloid related imaging abnormalities (ARIA) and cerebral macrohemorrhage.
Up to 112 Weeks
Number of Participants with Serious Adverse Events (SAEs) during the OLE
Time Frame: Up to 112 Weeks
A SAE is defined as any untoward medical occurrence that, at any dose, results in death and is life threatening requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a birth defect or congenital anomaly.
Up to 112 Weeks
Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE
Time Frame: Up to 112 Weeks
Magnetic resonance imaging (MRIs) will be used to monitor for abnormalities in the brain such as brain swelling and/or brain bleeding, which are termed as ARIAs.
Up to 112 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104
Time Frame: Baseline, Week 24, 52, 76, and 104
The CDR-SB score is a quantitative general index that provides more precision in participants with mild dementia. The CDR scale is a clinician-rated dementia staging system tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5- point scale in which 0=None, 0.5=Questionable, 1= Mild, 2=Moderate, and 3=Severe. The CDR-SB score is obtained by adding the ratings in each of the 6 categories and total score ranges from 0 to 18 with higher scores indicative of greater impairment.
Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in AD Assessment Scale-Cognitive subscale (ADAS-Cog14) Score Across Weeks 24, 52, 76, and 104
Time Frame: Baseline, Week 24, 52, 76, and 104
The AD Assessment Scale-Cognitive subscale (ADAS-Cog14) is a 14-item version of the test that assesses immediate and delayed memory, confrontational naming, ability to follow commands, ideational and constructional praxis, orientation, language, and attention. The ADAS Cog-14 score ranges from 0 to 90 and higher scores indicate greater impairment.
Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104
Time Frame: Baseline, Week 24, 52, 76, and 104
The MMSE is a brief test used to screen for cognitive impairment. It is routinely used for estimating the severity of cognitive impairment and tracking cognitive changes in an individual over time. The MMSE assesses orientation (time and place), registration, attention and calculation, recent memory, language (naming, comprehension, and repetition), and constructional praxis (copying a figure). The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive performance.
Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104
Time Frame: Baseline, Week 24, 52, 76, and 104
The AD Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-ADL-MCI). The ADCS-ADL for MCI is a 23-item scale that measures the competence of participants in basic and instrumental activities of daily living. Total scores on the ADCS-ADL-MCI range from 0 to 53 where lower scores indicates greater functional impairment.
Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in Integrated Alzheimers Disease Rating Scale (iADRS) Score Across Weeks 24, 52, 76, and 104
Time Frame: Baseline, Week 24, 52, 76, and 104
The iADRS is a composite tool that measures both cognition and function. The iADRS combines scores from the ADAS-Cog-14 and the Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living (ADCS-iADL). The ADAS-Cog-14 is a 14-item version of the test that assesses immediate and delayed memory, confrontational naming, ability to follow commands, ideational and constructional praxis, orientation, language, and attention. The ADCS-iADL is a 23-item scale measuring basic and instrumental abilities in participants with mild to moderate AD. The iADRS score is then computed as the sum of the transformed ADAS-Cog14 and the ADCS-iADL with scores ranging from 0 to 144 and lower scores indicating worse performance.
Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in Alzheimers Disease Composite Score (ADCOMS) Across Weeks 24, 52, 76 and 104
Time Frame: Baseline, Week 24, 52, 76 and 104
The ADCOMS is a composite score comprising scores from the MMSE, ADAS-Cog14, and CDR-SB. It contains a total of 12 cognitive and functional items, including 4 items from the ADAS-Cog14, 2 items from the MMSE, and 6 items from the CDR-SB. The ADCOMS scores range from 0 to 1.97, with a higher score indicative of greater impairment.
Baseline, Week 24, 52, 76 and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Collaborators

Alector Inc.

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2025

Primary Completion (Estimated)

September 15, 2028

Study Completion (Estimated)

December 8, 2028

Study Registration Dates

First Submitted

August 1, 2025

First Submitted That Met QC Criteria

August 1, 2025

First Posted (Actual)

August 6, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223646 (UC Davis)
  • 2025-521107-42 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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