A Phase 2b, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Safety and Efficacy of AD04 in Patients with Early Alzheimer’s Disease - ADVANCE

early Alzheimer’s disease

Composite score assessing cognition [adapted AD Assessment Scale cognitive (aADAS-cog)], daily function [adapted AD Cooperative Study Activities of Daily Living (aADCS-ADL)] and CDR-sb over 6 months measured in overall time saved with treatment

Safety Endpoints - Incidence of treatment-emergent adverse events (TEAEs), Key Secondary Efficacy Endpoint - Change from baseline in Clinical Dementia Rating - sum of boxes (CDRsb)., Other Secondary Efficacy Endpoints (I-III) - I. Global statistical test (GST) combining cognition [ADAS-cog] and daily function [ADCS-ADL] II. Change from baseline in hippocampal volume (total, right, and left), measured by volumetric Magnetic Resonance Imaging (MRI) III. Change from baseline in cognition score (ADAS-cog and aADAS-cog)., Other Secondary Efficacy Endpoints (IV-VII) - IV. Change from baseline in function score (ADCS-ADL and aADCS-ADL) V. Neuropsychiatric inventory (NPI) VI. Clinician’s Global Impressions of Change (CGIC) VII. Assessment of Quality of Life in patients with AD and their caregivers (QOL-AD), Exploratory endpoints – 1. Concentrations of aluminium in the blood, cerebrospinal fluid (CSF), and urine for pharmacokinetic profiling of AD04 (AUC and cumulative maximum concentration adjusted for pre-dose baseline values) 2. Levels of circulating biomarkers 3. PK/PD relationships

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Austria, Poland