A Multi-Centre, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 (AL101) in Participants With Early Alzheimer's Disease

Plain English Summary

Open-label Extension Study in Participants With Early Alzheimer's Disease is a Phase 2 clinical trial sponsored by GlaxoSmithKline studying Alzheimer's Disease. This study tests the long-term safety and effectiveness of a drug called GSK4527226. It is for people who have already participated in a previous study (NCT06079190) for early Alzheimer's disease. Participants will receive the study drug openly, meaning everyone knows which treatment is being given. This is an extension study, so you must have completed the main study to join. The trial aims to enroll 220 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have completed the main study (NCT06079190) and are willing to continue with the study drug. You cannot join if you have had certain brain imaging findings (like ARIA) or other serious medical conditions that prevent participation. Age is not specified, but the study is for early Alzheimer's disease, including mild cognitive impairment and mild dementia. You must be able to give informed consent and have a study partner who can provide information about your condition. This trial is studying Alzheimer's Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how safe the drug is over a longer period by tracking side effects, serious adverse events, and specific brain imaging changes. The specific primary outcome measures are: Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE (Up to 112 Weeks); Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE (Up to 112 Weeks); Number of Participants with Serious Adverse Events (SAEs) during the OLE (Up to 112 Weeks); Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE (Up to 112 Weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial matters because it aims to understand the long-term effects of a potential new treatment for early Alzheimer's disease, addressing the need for sustained therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Alzheimer's Disease, where improved treatment options are needed.

Investor Insight

This is a Phase 2 extension study for an Alzheimer's drug, indicating GlaxoSmithKline's continued investment in developing treatments for this large and growing market, with potential for future devel Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if you qualify based on your participation in the parent study and your current health status. Be prepared for regular clinic visits to monitor your health and receive the study medication. Ensure you have a reliable study partner who can attend visits and provide updates on your condition. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 220 participants

Interventions

• DRUG: GSK4527226 — GSK4527226 will be administered.

Primary Outcomes

• Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE (Up to 112 Weeks)
• Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE (Up to 112 Weeks)
• Number of Participants with Serious Adverse Events (SAEs) during the OLE (Up to 112 Weeks)
• Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE (Up to 112 Weeks)

Secondary Outcomes

• Change from OLE Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score Across Weeks 24, 52, 76, and 104 (Baseline, Week 24, 52, 76, and 104)
• Change from OLE Baseline in AD Assessment Scale-Cognitive subscale (ADAS-Cog14) Score Across Weeks 24, 52, 76, and 104 (Baseline, Week 24, 52, 76, and 104)
• Change from OLE Baseline in Mini - Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104 (Baseline, Week 24, 52, 76, and 104)
• Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104 (Baseline, Week 24, 52, 76, and 104)
• Change from OLE Baseline in Integrated Alzheimers Disease Rating Scale (iADRS) Score Across Weeks 24, 52, 76, and 104 (Baseline, Week 24, 52, 76, and 104)

Full Eligibility 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.

Trial Locations

• GSK Investigational Site, Maitland, Florida, United States
• GSK Investigational Site, Miami, Florida, United States
• GSK Investigational Site, Stuart, Florida, United States
• GSK Investigational Site, Toms River, New Jersey, United States
• GSK Investigational Site, Staten Island, New York, United States
• GSK Investigational Site, Matthews, North Carolina, United States
• GSK Investigational Site, Oklahoma City, Oklahoma, United States
• GSK Investigational Site, Houston, Texas, United States
• GSK Investigational Site, Fairfax, Virginia, United States
• GSK Investigational Site, Buenos Aires, Argentina
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Alzheimer's Disease
• Mild Cognitive Impairment
• Dementia
• Neurodegenerative Diseases
• Cognitive Disorders
• Neurology
• Geriatrics
• Brain Health
• Central Nervous System Disorders
• Memory Loss

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