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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 52, 64 and 76
Awards & highlights

PROGRESS-AD Trial 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.Check my eligibility
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.See study design
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.

PROGRESS-AD Trial Eligibility Criteria

Inclusion Criteria

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

PROGRESS-AD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

PROGRESS-AD 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
1,003 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,534 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,648 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this particular research endeavor include elderly participants?

"The age range for participation in this trial is between 50 and 85 years old, as specified by the eligibility criteria."

Answered by AI

Are there any restrictions for me to join this investigation?

"Those with alzheimer's disease aged between 50 and 85 are eligible to apply for this medical trial, which aims to recruit a total of 282 participants."

Answered by AI

What is the risk-benefit profile of GSK4527226 Dose 1 for patients?

"GSK4527226 Dose 1 is rated a 2 on the safety scale due to its status as Phase 2 trial, which carries some evidence of precaution but does not yet have any proof that it can be effective."

Answered by AI

Is this research study still recruiting participants?

"At the present time, clinicaltrials.gov has indicated that this trial is not actively recruiting patients. This study was first posted on October 11th 2023 and last updated 6 days later. Despite being inactive, there are still 537 trials searching for participants presently."

Answered by AI

What is the geographic scope of this experiment?

"91 different medical centres across the United States are running this clinical trial, including in DeLand, Maitland and Miami. For patient comfort it is important to select a location closest to them so as to minimize travel concerns."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease
2023. "Efficacy and Safety of GSK4527226 [AL101] in Participants With Early Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06079190.
All > Alzheimers Disease Miami > Vancouver
~188 spots leftby Dec 2026
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