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

NCT04191486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2023-10-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • FUJIFILM Toyama Chemical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Philip Scheltens, MD, PhD · VUmc Alzheimer Centrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-24
Primary Completion
2023-02-22
Completion
2023-03-20

Countries

  • Czechia
  • Germany
  • Hungary
  • Ireland
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04191486 on ClinicalTrials.gov