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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)
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.
Details
| Lead sponsor | AC Immune SA |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 176 |
| Start date | 2022-06-21 |
| Completion | 2026-06 |
Conditions
- Amyloid Plaque
- Beta-Amyloid
- DSAD
- Prodromal Alzheimer's Disease
- Alzheimer's Disease
Interventions
- Placebo
- ACI-24.060 at Dose A
- ACI-24.060 at Dose B
- ACI-24.060 at Dose C
- ACI-24.060 at Dose D
- Placebo
- ACI-24.060 at Dose A
- ACI-24.060 at Dose B
- ACI-24.060 at Dose C
Primary outcomes
- Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related) — From Screening to Week 74 (Study Part 1)
- Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, unlikely, possibly or probably related) — From Screening to Week 100 (Study Part 2)
- Number of participants with abnormal MRI results — From Baseline to Week 74 (Study Part 1)
- Number of participants with abnormal MRI results — From Baseline to Week 100 (Study Part 2)
- Number of participants with abnormal physical and neurological examination results — From Baseline to Week 74 (Study Part 1)
- Number of participants with abnormal physical and neurological examination results — From Baseline to Week 100 (Study Part 2)
Countries
United States, Spain, United Kingdom