Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD

Summary

Primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein phosphorylated at threonine 181 (p-tau 181) in cerebrospinal fluid (CSF) compared with placebo in patients with a diagnosis of MCI due to AD or mild AD. Secondary objectives are: 1. To evaluate in patients on T-817MA and placebo: * cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and working memory and attention domain as measured by the Cognitive Functional Composite (CFC). * AD-related biomarkers in CSF and plasma * imaging analysis using volumetric magnetic resonance imaging (vMRI) * alpha/theta ratio of the electroencephalogram (EEG) 2. To evaluate the safety of T-817MA by clinical laboratory tests and adverse events (AEs). 3. To evaluate the pharmacokinetics of T-817MA

Timeline

Start

2019-12-24

Primary completion

2023-02-22

Completion

2023-03-20

Drugs

Indications