GSK4527226

Open-label extension study in participants with early Alzheimer's disease

Conditions

Prodromal/Mild Cognitive Impairment due to Alzheimer’s disease

Mild Alzheimer's dementia

Sponsor

GlaxoSmithKline

Clinical Trial

Phase II

Status

Enrolling by invitation

Drug

GSK4527226

Countries

Finland, France, Germany, Norway, Spain, Sweden, United Kingdom

This study is an open-label extension study.

Information about the drug that will be tested in the study

Administration

The drug will be administered via an intravenous infusion (an injection into the vein).

Is the drug already on the market for another medical condition?

Will all participants receive the same drug?

All participants will receive GSK4527226.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the long-term safety and efficacy of GSK4527226 in people with early Alzheimer’s disease (including mild cognitive impairment and mild dementia due to Alzheimer’s disease) who have completed the PROGRESS-AD study.

How long will the treatment last?

Around 2 years

What your involvement will entail?

During the study, participants will be asked to complete tests that will assess their cognition, function, memory and activities of daily living (i.e. CDR-SB, iADRS, ADAS-Cog14, ADCS-iADL, ADCOMS)
Participants will undergo brain scans (MRI)
Complete some laboratory tests to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

Be between 50 and 85 years old
Have completed the parent study named PROGRESS-AD
Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration and report on cognitive and functional abilities
For female participants: not be pregnant or breastfeeding
Use contraception.

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

Evidence of any Amyloid related imaging abnormalities (ARIA) or cerebral macrohemorrhage
A disease or condition that may interfere with the safety, tolerability and/or study assessments
Newly identified conditions or diseases such as infection(s) that may affect the central nervous system, diagnosed cancer, genetic predisposition for clotting disorder or hemorrhagic disease
Severe alcohol and/or substance use disorder.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.