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)

Alzheimer's disease

Safety and Tolerability: Adverse events (AEs); physical and neurological examination results; global assessment of tolerability; vital signs; brain MRI assessment; electrocardiogram (ECG); routine hematology and biochemistry evaluation in blood and urine; inflammatory and autoimmune markers in blood and CSF; suicidality as measured with Columbia-Suicide Severity Rating Scale (C-SSRS).

Pharmacodynamic (Immunogenicity): Anti-Aβ antibody titers in serum (eg, geometric mean of antibody titers, change from baseline, responder rate, peak, and area under the curve [AUC]).

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