Last updated: 10/06/2025 12:20:08
Open-label Extension Study in Participants with Early Alzheimer’s Disease
GSK study ID
223646
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of Participants with Treatment Emergent Adverse Events (AEs) during the OLE
Timeframe: Up to 112 Weeks
Number of Participants with Adverse Event of Special Interest (AESIs) during the OLE
Timeframe: Up to 112 Weeks
Number of Participants with Serious Adverse Events (SAEs) during the OLE
Timeframe: Up to 112 Weeks
Number of Participants with Amyloid related imaging abnormalities (ARIAs) Including Severity during the OLE
Timeframe: 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
Timeframe: 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
Timeframe: Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in Mini – Mental State Exam (MMSE) Across Weeks 24, 52, 76, and 104
Timeframe: Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in ADCS-ADL-MCI Score Across Weeks 24, 52, 76, and 104
Timeframe: 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
Timeframe: Baseline, Week 24, 52, 76, and 104
Change from OLE Baseline in Alzheimers Disease Composite Score (ADCOMS) Across Weeks 24, 52, 76 and 104
Timeframe: Baseline, Week 24, 52, 76 and 104
Interventions:
Enrollment:
297
Primary completion date:
2028-01-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Alzheimer's Disease
Product
GSK4527226
Collaborators
Alector
Study date(s)
August 2025 to November 2028
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
50 - 85 Years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and exclusion 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 location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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