Alzheimer's Disease study: GSK4527226
Official title Open-label Extension Study in Participants With Early Alzheimer's Disease
ClinicalTrials.gov ID: NCT07105709
What this study is testing
What is GSK4527226?
GSK4527226 is an investigational medicine being studied for early Alzheimer’s disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe and effective GSK4527226 is over a longer period in people who already finished the earlier trial.
- Who it's for
- People who had early Alzheimer’s disease (mild cognitive impairment or mild dementia) and completed the parent study.
- What's involved
- All participants will receive GSK4527226 and will have regular visits and tests to monitor safety and disease progression.
- Time commitment
- The study lasts for the remaining period of the open‑label extension, with scheduled visits as directed by the investigators.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join 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...
- 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...
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of childbearing potential follows contraception...
You likely can't join 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...
- Other newly identified intracranial hemorrhage aneurysm, vascular malformation, infective lesion, space occupying lesion or brain tumor, or other...
- Newly identified infection(s) that may affect the Central nervous system (CNS).
- New diagnosis of moderate to severe alcohol and/or substance use disorder.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Maitland, Florida, United States
- Miami, Florida, United States
- Stuart, Florida, United States
- Toms River, New Jersey, United States
- Staten Island, New York, United States
- Matthews, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Buenos Aires, Argentina
- Ciudad Autonoma de Buenos Aire, Argentina
- Ciudad Autonoma de Bueno, Argentina
- Macquarie Park, New South Wales, Australia
- Nedlands, Western Australia, Australia
- Ottawa, Ontario, Canada
- Peterborough, Ontario, Canada
- Toronto, Ontario, Canada
- Greenfield Park, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Oulu, Finland
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Maitland, Florida, United States; Miami, Florida, United States; Stuart, Florida, United States; Toms River, New Jersey, United States; Staten Island, New York, United States; Matthews, North Carolina, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.