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

Last updated: October 19, 2023
Sponsor: FUJIFILM Toyama Chemical Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Memory Problems

Dementia

Memory Loss

Treatment

T-817MA

Placebo

Clinical Study ID

NCT04191486
T817MAEU201
2018-003567-66
  • Ages 50-80
  • All Genders

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

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Female of non-childbearing potential or male, ages 50 to 80 years (inclusive)
  • MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive)
  • CSF results at Screening consistent with the presence of Aß and p-tau181 abnormality (≤1000 pg/ml for Aß, ≥19 pg/ml for p-tau181).
  • Taking stable dose of AChE Inhibitor (donepezil, galantamine or rivastigmine) at leastfor 3 months prior to randomization, or not taking any AChE Inhibitors.

Exclusion

Key Exclusion Criteria:

  • MRI of the brain within the previous 2 years that showed pathology that would beinconsistent with a diagnosis of AD
  • Taking memantine
  • Any contraindications to lumbar puncture
  • Any contraindications to MRI

Study Design

Total Participants: 221
Treatment Group(s): 2
Primary Treatment: T-817MA
Phase: 2
Study Start date:
December 24, 2019
Estimated Completion Date:
March 20, 2023

Connect with a study center

  • FNUSA - Mezinarodni centrum klinickeho vyzkumu

    Brno,
    Czechia

    Site Not Available

  • FNHK - Neurologicka klinika

    Hradec Králové,
    Czechia

    Site Not Available

  • A-shine, s.r.o.

    Plzen,
    Czechia

    Site Not Available

  • CLINTRIAL, s.r.o.

    Prague,
    Czechia

    Site Not Available

  • VESTRACLINICS, s.r.o.

    Rychnov,
    Czechia

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt

    Frankfurt,
    Germany

    Site Not Available

  • Klinik für Neurologie Universitätsklinikum Schleswig-Holstein

    Kiel,
    Germany

    Site Not Available

  • Klinik und Poliklinik für Neurologie Universitätsklinikum Leipzig

    Leipzig,
    Germany

    Site Not Available

  • Universitätsklinikum Magdeburg Institut für Kognitive Neurologie und Demenzforschung

    Magdeburg,
    Germany

    Site Not Available

  • Institut für Studien zur Psychischen Gesundheit (ISPG)

    Mannheim,
    Germany

    Site Not Available

  • Technische Universität München

    München,
    Germany

    Site Not Available

  • Universitätsklinikum Münster Klinik für Allgemeine Neurologie

    Münster,
    Germany

    Site Not Available

  • Universitätsmedizin Rostock Zentrum für Nervenheilkunde Klinik für Psychosomatik und Psychotherapeutische Medizin

    Rostock,
    Germany

    Site Not Available

  • Universitätsklinikum Ulm Studienzentrum Klinik für Neurologie

    Ulm,
    Germany

    Site Not Available

  • Debreceni Egyetem KK, Pszichiátriai Klinika

    Budapest,
    Hungary

    Site Not Available

  • Jávorszky Ödön Városi Kórház, Gyógyszertár

    Debrecen,
    Hungary

    Site Not Available

  • Semmelweis Egyetem, Pszichiátriai és Pszichoterápiás Klinika

    Győr,
    Hungary

    Site Not Available

  • Semmelweis Egyetem Neurológiai Klinika Gyógyszertára, C földszint

    Vác,
    Hungary

    Site Not Available

  • St. Vincent's University Hospital

    Dublin,
    Ireland

    Site Not Available

  • Tallaght University Hospital.

    Dublin,
    Ireland

    Site Not Available

  • Brain Research Center Den Bosch

    's-Hertogenbosch,
    Netherlands

    Site Not Available

  • Brain Research Center

    Amsterdam,
    Netherlands

    Site Not Available

  • Amphia ziekenhuis

    Breda,
    Netherlands

    Site Not Available

  • Isala ziekenhuis

    Zwolle,
    Netherlands

    Site Not Available

  • Hospital General Universitari d' Elx

    Alicante,
    Spain

    Site Not Available

  • Fundació ACE

    Barcelona,
    Spain

    Site Not Available

  • Àrea Gestió Documentació Assaigs Clínics-AGDAC Hospital Santa Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clínico Universitario Virgen de La Arrixaca

    El Palmar,
    Spain

    Site Not Available

  • CAE Oroitu

    Getxo,
    Spain

    Site Not Available

  • Complejo Asistencial Universitario de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Santiago

    Santiago De Compostela,
    Spain

    Site Not Available

  • Hospital Victoria Eugenia - Cruz Roja

    Sevilla,
    Spain

    Site Not Available

  • Hospital Viamed Montecanal

    Zaragoza,
    Spain

    Site Not Available

  • University of Bath

    Bath,
    United Kingdom

    Site Not Available

  • Southmead Hospital North Bristol NHS Trust

    Bristol,
    United Kingdom

    Site Not Available

  • Glasgow memory Clinic

    Glasgow,
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust

    London,
    United Kingdom

    Site Not Available

  • Memory Assessment & Research Centre

    Southampton,
    United Kingdom

    Site Not Available

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