An Exploratory Phase 2 Multicenter, Double-blind, Randomized, Placebo controlled, Parallel Group Study to Investigate the Safety, Tolerability, and Efficacy of TML-6 in Early Alzheimer’s Disease

Condition studied

Early Alzheimer’s Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

1. Primary efficacy endpoint: Change in the Clinical Dementia Rating -Sum of Boxes (CDR-SB) from baseline to Week 52.

Endpoint detail

1. Efficacy Endpoints • Change in the Integrated Alzheimer’s Disease Rating Scale (iADRS) from baseline to Week 52. • Change in selected blood biomarkers (p-Tau217, amyloid β-protein Aβ40, and Aβ42) from baseline to Week 52., 2. Safety Endpoints: The safety endpoints of this study are as follows: • spontaneously reported adverse events (AEs) • clinical laboratory tests • vital sign and body weight measurements • physical and neurological examinations • Columbia Suicide Severity Rating Scale (C-SSRS), 3. Exploratory endpoints: • Change in blood biomarkers (neurofilament light chain and glial fibrillary acidic protein) from baseline to Week 52 • Change of brain volume in volumetric magnetic resonance imaging (vMRI) measures at baseline and Week 52 • Plasma PK of TML-6 treatment after first dose • Change in brain amyloid pathophysiology from baseline to Week 52 as measured by amyloid positron emission tomography (PET) scans at selected study sites