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Monoclonal Antibodies

GSK4527226 for Early Alzheimer's Disease (PROGRESS-AD Trial)

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A female participant is eligible to participate if she is not pregnant or breastfeeding, and if of child-bearing potential follows contraception requirements outlined in the protocol
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.
Must not have
History of severe, clinically significant central nervous system (CNS) trauma.
Participant has evidence of any neurological condition other than AD that may contribute to cognitive impairment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 52, 64 and 76

Summary

This trial will study if a new drug is safe and effective in people with early Alzheimer's, including mild cognitive impairment and mild dementia.

Who is the study for?
This trial is for adults with early Alzheimer's Disease, including mild cognitive impairment and mild dementia. They must have certain scores on memory and cognition tests, evidence of amyloid in the brain, stable medication regimens if taking Alzheimer's drugs, a body weight between 45-120 kg with specific BMI limits, and not be pregnant or breastfeeding. Participants need to use contraception and have a study partner who can provide information about their condition.
What is being tested?
The trial is testing GSK4527226 (AL101) at two dose levels against a placebo to see how effective and safe it is for people with early-stage Alzheimer's Disease. The participants will be randomly assigned to receive either the drug or placebo.
What are the potential side effects?
While specific side effects are not listed here, clinical trials typically monitor for any adverse reactions ranging from minor issues like headaches or nausea to more serious ones such as allergic reactions or worsening of symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or breastfeeding and will follow the study's birth control requirements.
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I have been diagnosed with mild cognitive impairment or mild Alzheimer's disease.
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My weight is between 45 and 120 kg, and my BMI is between 17 and 34.9.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a serious brain injury.
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I have a neurological condition other than Alzheimer's that affects my thinking.
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I have a history of vascular disease that could impact my brain function.
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I have not had a stroke or a mini-stroke in the last year.
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My last Hemoglobin A1c was over 8% or my diabetes has been poorly controlled in the last 3 months.
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I haven't taken immunosuppressive drugs in the last 90 days.
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I have current or past infections that affected my brain function.
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I have not taken blood thinners in the last 90 days and won't during the study.
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I am scheduled for surgery requiring anesthesia during the study.
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I have or had a brain tumor.
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I have had cancer in the past.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 52, 64 and 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 52, 64 and 76 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Secondary study objectives
Change from Baseline in ADAS-Cog14 Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Change from Baseline in ADCS-ADL-MCI Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
Change from Baseline in ADCS-iADL component of ADCS-ADL-MCI Score for Dose 1 vs Placebo Across Weeks 52, 64 and 76
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: GSK4527226 Dose 2Experimental Treatment1 Intervention
Participants will receive GSK4527226 Dose 2
Group II: GSK4527226 Dose 1Experimental Treatment1 Intervention
Participants will receive GSK4527226 Dose 1
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive placebo.

Find a Location

Who is running the clinical trial?

Alector Inc.Industry Sponsor
10 Previous Clinical Trials
981 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,805 Previous Clinical Trials
8,379,221 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,589 Total Patients Enrolled
~183 spots leftby Dec 2026
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