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

Official title

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

Overview

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.

Interventions

• Drug GSK4527226
  GSK4527226 will be administered.

Primary outcome measures

• Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE [Time frame: Up to 112 Weeks]
• Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE [Time frame: Up to 112 Weeks]
• Number of Participants with Serious Adverse Events (SAEs) during the OLE [Time frame: Up to 112 Weeks]
• Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE [Time frame: Up to 112 Weeks]

Secondary outcome measures (6)

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 9 centers

• GSK Investigational Site — Maitland
• GSK Investigational Site — Miami
• GSK Investigational Site — Stuart
• GSK Investigational Site — Toms River
• GSK Investigational Site — Staten Island
• GSK Investigational Site — Matthews
• GSK Investigational Site — Oklahoma City
• GSK Investigational Site — Houston
• … and 1 more center

Canada · 5 centers

• GSK Investigational Site — Ottawa
• GSK Investigational Site — Peterborough
• GSK Investigational Site — Toronto
• GSK Investigational Site — Greenfield Park
• GSK Investigational Site — Sherbrooke

Argentina · 4 centers

• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Ciudad Autonoma de Buenos Aire
• GSK Investigational Site — Ciudad Autonoma de Bueno

Sweden · 3 centers

• GSK Investigational Site — Gothenburg
• GSK Investigational Site — Malmö
• GSK Investigational Site — Stockholm

United Kingdom · 3 centers

• GSK Investigational Site — Birmingham
• GSK Investigational Site — Bristol
• GSK Investigational Site — London

Australia · 2 centers

• GSK Investigational Site — Macquarie Park
• GSK Investigational Site — Nedlands

Norway · 2 centers

• GSK Investigational Site — Bergen
• GSK Investigational Site — Oslo

Taiwan · 2 centers

• GSK Investigational Site — Tainan
• GSK Investigational Site — Taoyuan

Finland · 1 center

• GSK Investigational Site — Oulu

South Korea · 1 center

• GSK Investigational Site — Junggu

Spain · 1 center

• GSK Investigational Site — Barcelona

Identifiers

NCT: NCT07105709 · 223646 · 2025-521107-42

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗