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

NCT ID: NCT07105709

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-14

Study Completion Date

2028-11-24

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study.

Study Groups

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GSK4527226

Participants will receive GSK4527226.

Group Type EXPERIMENTAL

GSK4527226

Intervention Type DRUG

GSK4527226 will be administered.

Interventions

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GSK4527226

GSK4527226 will be administered.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alector Inc.

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Maitland, Florida, United States

Site Status RECRUITING

GSK Investigational Site

Miami, Florida, United States

Site Status RECRUITING

GSK Investigational Site

Stuart, Florida, United States

Site Status RECRUITING

GSK Investigational Site

Toms River, New Jersey, United States

Site Status RECRUITING

GSK Investigational Site

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

GSK Investigational Site

Fairfax, Virginia, United States

Site Status RECRUITING

GSK Investigational Site

Ciudad Autonoma de Bueno, , Argentina

Site Status RECRUITING

GSK Investigational Site

Macquarie Park, New South Wales, Australia

Site Status RECRUITING

GSK Investigational Site

Ottawa, Ontario, Canada

Site Status RECRUITING

GSK Investigational Site

Peterborough, Ontario, Canada

Site Status RECRUITING

GSK Investigational Site

Toronto, Ontario, Canada

Site Status RECRUITING

GSK Investigational Site

Greenfield Park, Quebec, Canada

Site Status RECRUITING

GSK Investigational Site

Sherbrooke, Quebec, Canada

Site Status RECRUITING

GSK Investigational Site

Junggu, , South Korea

Site Status RECRUITING

GSK Investigational Site

Gothenburg, , Sweden

Site Status RECRUITING

GSK Investigational Site

Malmo, , Sweden

Site Status RECRUITING

GSK Investigational Site

Stockholm, , Sweden

Site Status RECRUITING

GSK Investigational Site

Taoyuan District, , Taiwan

Site Status RECRUITING

GSK Investigational Site

Bristol, , United Kingdom

Site Status RECRUITING

GSK Investigational Site

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Canada South Korea Sweden Taiwan United Kingdom

Central Contacts

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US GSK Clinical Trials Call Center

Role: CONTACT

Phone: 877-379-3718

Email: [email protected]

EU GSK Clinical Trials Call Center

Role: CONTACT

Phone: +44 (0) 20 89904466

Email: [email protected]

Facility Contacts

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US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

Other Identifiers

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2025-521107-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

223646

Identifier Type: -

Identifier Source: org_study_id