A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
NCT05462106 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 176
Last updated 2025-12-15
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.
Conditions
- Amyloid Plaque
- Beta-Amyloid
- DSAD
- Prodromal Alzheimer's Disease
- Alzheimer's Disease
Interventions
- BIOLOGICAL
-
Administration of Placebo
- BIOLOGICAL
-
ACI-24.060 at Dose A
Administration of Dose A of ACI-24.060
- BIOLOGICAL
-
ACI-24.060 at Dose B
Administration of Dose B of ACI-24.060
- BIOLOGICAL
-
ACI-24.060 at Dose C
Administration of Dose C of ACI-24.060
- BIOLOGICAL
-
ACI-24.060 at Dose D
Administration of Dose D of ACI-24.060
- BIOLOGICAL
-
Administration of Placebo
- BIOLOGICAL
-
ACI-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
- BIOLOGICAL
-
ACI-24.060 at Dose B
Administration of Dose B of ACI-24.060
- BIOLOGICAL
-
ACI-24.060 at Dose C
Administration of Dose C of ACI-24.060
Sponsors & Collaborators
-
Worldwide Clinical Trials
collaborator OTHER -
AC Immune SA
lead INDUSTRY
Principal Investigators
-
Michael Rafii, MD · University of Southern California, Alzheimer's Therapeutic Research Institute, 9860 Mesa Rim Rd, San Diego, CA 92121, USA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 35 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-21
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
- Spain
- United Kingdom
Study Locations
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