RecruitingPhase 2

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

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

Lead sponsor

GlaxoSmithKline

Asset

GSK4527226

Listed sites

Recruiting sites

Enrollment

220

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Age 50-85•MRI contraindications excluded

Primary endpoints

•Treatment Emergent Adverse Events (AEs) during the OLE•Adverse Event of Special Interest (AESIs) during the OLE•Serious Adverse Events (SAEs) during the OLE

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Registry2025-521107-42EU CTIS

Org study ID223646

NCT IDNCT07105709

Timeline

Milestones

Study first posted2025-08-06actual

Study start2025-08-14actual

Last update posted2026-02-02actual

Primary completion2028-09-15estimated

Study completion2028-12-08estimated

Assets

Drug assets

GSK4527226

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Amyloid biomarkers

Safety / tolerability / PK

Function / daily living

Global cognition

5 endpoints

Secondary/protocol endpoint

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

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Secondary/protocol endpoint

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

ADAS-Cog

descriptive

Secondary/protocol endpoint

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

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/protocol endpoint

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

ADAS-Cog

descriptive

Secondary/protocol endpoint

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

ADAS-Cog

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

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

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE

Time frame:Up to 112 Weeks

event count, event

Primary/protocol endpoint

Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE

Time frame:Up to 112 Weeks

event count, event

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

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

Time frame:Up to 112 Weeks

event count, event

Primary/protocol endpoint

Number of Participants with Serious Adverse Events (SAEs) during the OLE

Time frame:Up to 112 Weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.