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

Mild Cognitive Impairment Clinical Trial

Official title: A Phase 2 Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT04191486
• Study type: Interventional
• Source: FUJIFILM Toyama Chemical Co., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: December 24, 2019
• Completion date: March 20, 2023