Loading clinical trials...

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

A Phase 2, Parallel Group, Randomized, Double- Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared With Placebo in Patients With Early Alzheimer's Disease

NCT06079190•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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 impairment \[MCI\] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must be in the Alzheimer's continuum as defined by the 2018 National Institute on Aging and Alzheimer's Association (NIAAA) Research Framework corresponding to the clinical categories of MCI due to AD and mild AD dementia.
•Participant must have evidence of amyloid positivity either by positive positron emission tomography (PET) result (Amyloid PET scans must be read by a central imaging lab) or cerebrospinal fluid (CSF) amyloid beta (Aβ) test result indicative of amyloid positivity
•Participants must also meet the following criteria for clinical severity:
•1. MMSE score of between 21 and 29 points
•2. CDR-global score (GS) of 0.5 to 1.0.
•3. CDR Memory Box score greater than or equal to (≥) 0.5.
•4. Participants with objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale-IV Logical Memory II (WMS-IV LMII)
•If the participant is receiving symptomatic AD medications such as an Acetylcholinesterase inhibitor (AChEI) or memantine, the dosing regimen must have been stable for at least 12 weeks prior to screening and is not expected to change during study participation.
•If the participant is receiving other medications for AD related symptoms or associated conditions, the dosing regimen must have been stable for at least 4 weeks prior to screening and not expected to change during study participation. Symptoms must be considered adequately and stably controlled by the investigator, without marked changes in medication anticipated for the duration of the study.
•Body weight ≥ 45 kilogram (kg) to less than or equal to (≤)120 kg with body mass index (BMI) between 17 and 34.9 kilogram per meter square (kg/m\^2), inclusive.
+4 more criteria

Exclusion Criteria

•Participant has evidence of any neurological condition other than AD that may contribute to cognitive impairment.
•History or presence of vascular disease that has the potential to affect cognitive function.
•History or presence of stroke within the past 1 year or recent transient ischemic attack within 180 days before screening.
•History of severe, clinically significant central nervous system (CNS) trauma.
•History or presence of intracranial tumor.
•Presence of ongoing infection(s) that may affect brain function, or history of infections that resulted in neurologic sequelae.
•History of primary psychiatric diagnosis that the investigator considers may interfere with study assessments.
•Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation Type 4 or 5, suicidal behaviour or has been assessed to be at risk of suicide, in the opinion of the investigator within 6 months before screening, at screening, or at the Baseline visit, or has been hospitalized or treated for suicidal behaviour in the past 2 years.
•Participant has history of alcohol and/or moderate to severe substance use disorder within the past 2 years
•Magnetic resonance imaging (MRI) evidence based on central read of:
+27 more criteria

Locations (97)

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Lake Mary, Florida, United States

GSK Investigational Site

Lake Worth, Florida, United States

GSK Investigational Site

Maitland, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Stuart, Florida, United States

GSK Investigational Site

The Villages, Florida, United States

GSK Investigational Site

The Villages, Florida, United States

Key Dates

Start Date

October 20, 2023

Primary Completion Date

September 30, 2026

Completion Date

November 23, 2026

Last Updated

November 14, 2025

Enrollment

367

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

GSK4527226

DRUG

Placebo

OTHER

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia