NCT04191486

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: FUJIFILM Toyama Chemical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	T-817MA	224mg T-817MA orally once daily for first 4 weeks, and then 448mg T-817MA orally once daily for the following weeks.
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2019-12-24
• Primary completion: 2023-02-22
• Completion: 2023-03-20
• First posted: 2019-12-09
• Last updated: 2023-10-23

Locations

37 sites across 7 countries: Czechia, Germany, Hungary, Ireland, Netherlands, Spain, United Kingdom