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)
AC Immune SA
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.
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.
Eligibility
- Age range
- 35–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Study Part 1 1. Age ≥50 and ≤85 years at screening. 2. Diagnosis of prodromal AD: MCI due to AD according to National Institute on Aging Alzheimer's Association (NIA-AA) criteria. 3. PET scan at screening consistent with the presence of amyloid pathology. 4. Clinical Dementia Rating (CDR)-Global Score of 0.5. 5. Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor (ACHEI) and/or memantine for at least 2 months prior to baseline. Study Part 2 1. Age ≥35 and ≤50 years at screening (subjects with DS with a…
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
Locations (19)
- Barrow Neurological InstitutePhoenix, Arizona
- Indiana University / IU HealthIndianapolis, Indiana
- University of Kansas Medical Center Research InstituteFairway, Kansas
- Massachusetts General HospitalBoston, Massachusetts
- The Washington UniversitySt Louis, Missouri
- Vanderbilt University Medical CenterNashville, Tennessee