Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05462106

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)

Status
Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
176 (estimated)
Sponsor
AC Immune SA · Industry
Sex
All
Age
35 Years – 85 Years
Healthy volunteers
Not accepted

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.

Detailed description

This phase 1b/2 study will be in 2 parts. Study Part 1 will involve subjects with prodromal Alzheimer's disease. Study Part 2 will involve subjects with Down syndrome.

Conditions

Interventions

TypeNameDescription
BIOLOGICALPlaceboAdministration of Placebo
BIOLOGICALACI-24.060 at Dose AAdministration of Dose A of ACI-24.060
BIOLOGICALACI-24.060 at Dose BAdministration of Dose B of ACI-24.060
BIOLOGICALACI-24.060 at Dose CAdministration of Dose C of ACI-24.060
BIOLOGICALACI-24.060 at Dose DAdministration of Dose D of ACI-24.060
BIOLOGICALPlaceboAdministration of Placebo
BIOLOGICALACI-24.060 at Dose AAdministration of Dose A of ACI-24.060. Dose A will be a dose already tested in Study Part 1
BIOLOGICALACI-24.060 at Dose BAdministration of Dose B of ACI-24.060
BIOLOGICALACI-24.060 at Dose CAdministration of Dose C of ACI-24.060

Timeline

Start date
2022-06-21
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2022-07-18
Last updated
2025-12-15

Locations

19 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05462106. Inclusion in this directory is not an endorsement.