Open-label Extension Study in Participants With Early Alzheimer's Disease
GlaxoSmithKline · with Alector Inc. · NCT07105709
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50–85 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 220
- US sites recruiting
- 9
- Study start
- August 14, 2025
- Record last updated
- February 2, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: GSK4527226
Conditions: Alzheimer's Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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may be on a temporary dose suspension but must not have been permanently discontinued early from study intervention or withdrawn from the parent study.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.
Recruiting US locations
GSK Investigational Site
Maitland, FL 32752
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Miami, FL 33176
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Stuart, FL 34997
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Toms River, NJ 08755
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Staten Island, NY 10314
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Matthews, NC 28105
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Oklahoma City, OK 73112
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Houston, TX 77030
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Fairfax, VA 22031
Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
Study contacts (from the official record)
- US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Center · +44 (0) 20 89904466 · GSKClinicalSupportHD@gsk.com
Similar studies in Florida
All neurology studies in Florida →- RecruitingHealthy volunteersPhase 1
A Study of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease
Eli Lilly and Company
- Location
- Daytona Beach, FL
- Eligibility basics
- Ages 18–85
- RecruitingHealthy volunteersPhase 1
A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's Disease
Prevail Therapeutics
- Location
- Naples, FL + 1 other US site
- Eligibility basics
- Ages 30–80
- RecruitingHealthy volunteersPhase 1
A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
Eli Lilly and Company
- Location
- Naples, FL + 7 other US sites
- Eligibility basics
- Ages 30–85
- RecruitingHealthy volunteersPhase 1
A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease
Eli Lilly and Company
- Location
- Daytona Beach, FL
- Eligibility basics
- Ages 18–85