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

NCT07105709 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2236462025-521107-42
• Study Type: interventional
• Target: 220
• Locations: 11 countries
• Sites: 33

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE

  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

  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

  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

  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 Outcomes (6)

• Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104

  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

  Baseline, Week 24, 52, 76, and 104

• Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104

  Baseline, Week 24, 52, 76, and 104

• Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104

  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

  Baseline, Week 24, 52, 76, and 104

Study Arms (1)

GSK4527226

EXPERIMENTAL

Participants will receive GSK4527226.

Drug: GSK4527226

Interventions

GSK4527226 DRUG

GSK4527226 will be administered.

GSK4527226

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Alector Inc.: collaborator

Study Sites (33)

GSK Investigational Site

Maitland, Florida, 32752, United States

RECRUITING

GSK Investigational Site

Miami, Florida, 33176, United States

RECRUITING

GSK Investigational Site

Stuart, Florida, 34997, United States

RECRUITING

GSK Investigational Site

Toms River, New Jersey, 08755, United States

RECRUITING

GSK Investigational Site

Staten Island, New York, 10314, United States

RECRUITING

GSK Investigational Site

Matthews, North Carolina, 28105, United States

RECRUITING

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

GSK Investigational Site

Houston, Texas, 77030, United States

RECRUITING

GSK Investigational Site

Fairfax, Virginia, 22031, United States

RECRUITING

GSK Investigational Site

Buenos Aires, 1897, Argentina

RECRUITING

GSK Investigational Site

Buenos Aires, C1425AGC, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1431FWO, Argentina

RECRUITING

GSK Investigational Site

Ciudad Autonoma de Bueno, C1056ABJ, Argentina

RECRUITING

GSK Investigational Site

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

GSK Investigational Site

Nedlands, Western Australia, 6009, Australia

RECRUITING

GSK Investigational Site

Ottawa, Ontario, K1Z 1G3, Canada

RECRUITING

GSK Investigational Site

Peterborough, Ontario, K9H 2P4, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M3B 2S7, Canada

RECRUITING

GSK Investigational Site

Greenfield Park, Quebec, J4V 2J2, Canada

RECRUITING

GSK Investigational Site

Sherbrooke, Quebec, J1J 2G2, Canada

RECRUITING

GSK Investigational Site

Oulu, 90100, Finland

RECRUITING

GSK Investigational Site

Bergen, 5009, Norway

RECRUITING

GSK Investigational Site

Oslo, 0450, Norway

RECRUITING

GSK Investigational Site

Junggu, 400711, South Korea

RECRUITING

GSK Investigational Site

Barcelona, 08028, Spain

RECRUITING

GSK Investigational Site

Gothenburg, 431 41, Sweden

RECRUITING

GSK Investigational Site

Malmo, 21146, Sweden

RECRUITING

GSK Investigational Site

Stockholm, Sweden

RECRUITING

GSK Investigational Site

Tainan, 704, Taiwan

RECRUITING

GSK Investigational Site

Taoyuan District, 333, Taiwan

RECRUITING

GSK Investigational Site

Birmingham, B16 8LT, United Kingdom

RECRUITING

GSK Investigational Site

Bristol, BS32 4SY, United Kingdom

RECRUITING

GSK Investigational Site

London, W1G 8TA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders

Condition Hierarchy (Ancestors)

Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 6, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): September 15, 2028
• Study Completion (Estimated): December 8, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

TW (2); FI (1); CA (5); GB (3); NO (2); US (9); AU (2); ES (1); KR (1); AR (4); SE (3)