RecruitingPhase 1Phase 2NCT05462106

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)

A Phase 1b/2, Multicenter, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-24.060 in Subjects With Prodromal Alzheimer's Disease and in Adults With Down Syndrome (ABATE)

Sponsor

AC Immune SA

Enrollment

176 participants

Start Date

Jun 21, 2022

Study Type

INTERVENTIONAL

Conditions

Beta-Amyloid Prodromal Alzheimer's Disease Amyloid Plaque DSAD

Summary

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.

Eligibility

Min Age: 35 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new vaccine-like treatment called ACI-24.060, which aims to help the immune system clear amyloid plaques — the sticky protein clumps linked to Alzheimer's disease — from the brain. The study includes adults with early Alzheimer's disease and also adults with Down syndrome who are at high risk. **You may be eligible if...** - You are 50–85 years old with early (prodromal) Alzheimer's disease — meaning mild memory problems — confirmed by a brain amyloid scan - OR you are an adult with Down syndrome aged 25 or older with confirmed amyloid buildup - Your condition is at an early stage (CDR score of 0.5) **You may NOT be eligible if...** - You have moderate or severe dementia - You have had a stroke or significant brain abnormalities - You have serious heart, kidney, or liver disease - You are on blood thinners Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPlacebo

Administration of Placebo

BIOLOGICALACI-24.060 at Dose A

Administration of Dose A of ACI-24.060

BIOLOGICALACI-24.060 at Dose B

Administration of Dose B of ACI-24.060

BIOLOGICALACI-24.060 at Dose C

Administration of Dose C of ACI-24.060

BIOLOGICALACI-24.060 at Dose D

Administration of Dose D of ACI-24.060

BIOLOGICALPlacebo

Administration of Placebo

BIOLOGICALACI-24.060 at Dose A

Administration of Dose A of ACI-24.060. Dose A will be a dose already tested in Study Part 1

BIOLOGICALACI-24.060 at Dose B

Administration of Dose B of ACI-24.060

BIOLOGICALACI-24.060 at Dose C

Administration of Dose C of ACI-24.060

Locations(19)

Barrow Neurological Institute

Phoenix, Arizona, United States

Indiana University / IU Health

Indianapolis, Indiana, United States

University of Kansas Medical Center Research Institute

Fairway, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

The Washington University

St Louis, Missouri, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Health San Antonio

San Antonio, Texas, United States

Fundació ACE, Institut Català de Neurociències Aplicades

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Virgen De Las Nieves

Granada, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Cambridge and Peterborough NHS Foundation Trust - Windsor Research Units

Cambridge, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Re:Cognition Health Limited

London, United Kingdom

South London and Maudsley NHS Foundation Trust of The Maudsley Hospital

London, United Kingdom

Oxford Health NHS Foundation Trust

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05462106

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