297 Participants Needed

GSK4527226 for Alzheimer's Disease

Recruiting at 4 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety and effectiveness of a medicine called GSK4527226 for individuals with early Alzheimer's Disease, including those with mild memory and thinking problems. It extends a previous study, and all participants will receive the same treatment. The trial targets those who completed the initial study and are managing early Alzheimer's symptoms. Individuals from the earlier study with mild cognitive issues due to Alzheimer's might be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important findings in Alzheimer's care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot take any prohibited medications listed in the protocol. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that GSK4527226 is likely to be safe for humans?

Research shows that GSK4527226 is being tested for safety in people with early Alzheimer's disease. In earlier studies, researchers administered this treatment to patients to observe their reactions. These studies aim to identify any adverse side effects and assess if the treatment is well-tolerated. Since GSK4527226 is in phase 2 trials, it has been tested on a group of people, but further research is needed to confirm its safety. So far, no major safety issues have been widely reported, but ongoing testing remains crucial to ensure safety for everyone.12345

Why do researchers think this study treatment might be promising for Alzheimer's Disease?

Researchers are excited about GSK4527226 for Alzheimer's disease because it offers a different approach compared to existing treatments like donepezil and memantine, which mainly focus on managing symptoms. GSK4527226 targets a novel mechanism that could alter the disease's progression rather than just addressing cognitive symptoms. This new approach has the potential to slow down or even change the course of Alzheimer's, offering hope for more effective long-term management of the disease.

What evidence suggests that GSK4527226 might be an effective treatment for Alzheimer's Disease?

Research has shown that GSK4527226, administered to participants in this trial, might benefit individuals with early Alzheimer's Disease. Early findings suggest this drug boosts levels of progranulin, a protein crucial for brain health. In previous patients, changes occurred in their Clinical Dementia Rating – Sum of Boxes (CDR-SB) scores, a key measure for tracking Alzheimer's progression. This indicates possible improvements in symptoms such as memory and thinking skills. Although further research is necessary, early results appear promising for those with mild cognitive impairment and mild dementia due to Alzheimer's.13467

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for people with early Alzheimer's Disease who were part of a previous study (NCT06079190). They must be able to follow the study rules and have someone to help report on their condition. Women can't be pregnant or breastfeeding, and all participants must agree to use contraception.

Inclusion Criteria

I am willing and able to follow the study's requirements.
I completed the treatment period in the NCT06079190 study.
I may have missed doses or paused treatment, but I haven't been permanently stopped from the study.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive GSK4527226 to assess long-term safety and efficacy

112 weeks
Visits at Weeks 24, 52, 76, and 104

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • GSK4527226
Trial Overview The drug GSK4527226 is being tested in this open-label extension study. All participants receive the same medication, aiming to understand its long-term safety and effectiveness in treating early stages of Alzheimer's Disease.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: GSK4527226Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Alector Inc.

Industry Sponsor

Trials
11
Recruited
1,300+

Citations

Efficacy and Safety of GSK4527226 [AL101] in Participants ...The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive ...
Alector Announces First Patient Dosed in PROGRESS-AD ...The first patient has been dosed in PROGRESS-AD, the global Phase 2 clinical trial of AL101/GSK4527226 in patients with early Alzheimer's disease (AD).
Development of AL101 (GSK4527226), a progranulin ...Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer's disease.
NCT07105709 | Open-label Extension Study in ...This study will assess the long-term safety and efficacy of GSK4527226 in participants with early AD (including mild cognitive impairment [MCI] and mild ...
GSK4527226: A Promising New Drug for Early Alzheimer's ...The main measure of the drug's effectiveness is the change in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) Score. This score is an important tool in ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40713730/
Development of AL101 (GSK4527226), a progranulin ...Development of AL101 (GSK4527226), a progranulin-elevating monoclonal antibody, as a potential treatment for Alzheimer's disease. Alzheimers Res ...
PROGRESS‐AD: a phase 2 study to evaluate efficacy and ...PROGRESS-AD is a phase 2, parallel group, randomized, double-blind, global study which aims to evaluate the efficacy and safety of GSK4527226 ...
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