Phase 1/2RecruitingAge-related condition
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 (Industry)
- Enrolment
- 304 planned
- Conditions
- Amyloid Plaque; Beta-Amyloid; DSAD; Prodromal Alzheimer's Disease; Alzheimer's Disease
- Interventions
- Placebo (Study Part 1a); ACI-24.060 at Dose A in Study Part 1a; ACI-24.060 at Dose B in Study Part 1a; ACI-24.060 at Dose C in Study Part 1a; ACI-24.060 with an additional adjuvant at Dose D in Study Part 1b; Placebo (Study Part 2); ACI-24.060 at Dose A in Study Part 2; ACI-24.060 at Dose B in Study Part 2; ACI-24.060 at Dose C in Study Part 2; Placebo (Study Part 1b); ACI-24.060 with an additional adjuvant at Dose E in Study Part 1b
- Ages
- adults, older adults
- Registry
- NCT05462106
Full record on ClinicalTrials.gov
From the registry
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.
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)
- Number of participants with abnormal MRI results
- Number of participants with abnormal physical and neurological examination results
- Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
History
Primary completion expected
Last registry update
Registered
Started