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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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
T-817MA
Placebo
Sponsored by
FUJIFILM Toyama Chemical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 least for 3 months prior to randomization, or not taking any AChE Inhibitors.

Key Exclusion Criteria:

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

Sites / Locations

  • FNUSA - Mezinarodni centrum klinickeho vyzkumu
  • FNHK - Neurologicka klinika
  • A-shine, s.r.o.
  • CLINTRIAL, s.r.o.
  • VESTRACLINICS, s.r.o.
  • Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
  • Klinik für Neurologie Universitätsklinikum Schleswig-Holstein
  • Klinik und Poliklinik für Neurologie Universitätsklinikum Leipzig
  • Universitätsklinikum Magdeburg Institut für Kognitive Neurologie und Demenzforschung
  • Institut für Studien zur Psychischen Gesundheit (ISPG)
  • Technische Universität München
  • Universitätsklinikum Münster Klinik für Allgemeine Neurologie
  • Universitätsmedizin Rostock Zentrum für Nervenheilkunde Klinik für Psychosomatik und Psychotherapeutische Medizin
  • Universitätsklinikum Ulm Studienzentrum Klinik für Neurologie
  • Debreceni Egyetem KK, Pszichiátriai Klinika
  • Jávorszky Ödön Városi Kórház, Gyógyszertár
  • Semmelweis Egyetem, Pszichiátriai és Pszichoterápiás Klinika
  • Semmelweis Egyetem Neurológiai Klinika Gyógyszertára, C földszint
  • St. Vincent's University Hospital
  • Tallaght University Hospital.
  • Brain Research Center Den Bosch
  • Brain Research Center
  • Amphia ziekenhuis
  • Isala ziekenhuis
  • Hospital General Universitari d' Elx
  • Fundació ACE
  • Àrea Gestió Documentació Assaigs Clínics-AGDAC Hospital Santa Creu i Sant Pau
  • Hospital Clínico Universitario Virgen de La Arrixaca
  • CAE Oroitu
  • Complejo Asistencial Universitario de Salamanca
  • Hospital Victoria Eugenia - Cruz Roja
  • Hospital Viamed Montecanal
  • University of Bath
  • Southmead Hospital North Bristol NHS Trust
  • Glasgow memory Clinic
  • Imperial College Healthcare NHS Trust
  • Memory Assessment & Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

T-817MA (448 mg)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The change in the CSF p-tau181 from Baseline to Week 78

Secondary Outcome Measures

The change in the CSF p-tau181 from Baseline to Week 52
The change in the CSF p-tau217 from Baseline to Weeks 52 and 78
The change in the CSF total tau from Baseline to Weeks 52 and 78
The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78
The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78
The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78
The change in the CSF neurogranin from Baseline to Weeks 52 and 78
The change in the CSF YKL-40 from Baseline to Weeks 52 and 78
The change in the CSF Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78
The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78
The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78
The change in the plasma NFL from Baseline to Weeks 52 and 78
The change in cognitive function assessed by CDR-sb and working memory and attention domain as measured by the CFC from Baseline to Weeks 28, 52 and 78
The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78
The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78
Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs
Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax)
Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin)
Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h)

Full Information

First Posted
November 26, 2019
Last Updated
October 19, 2023
Sponsor
FUJIFILM Toyama Chemical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04191486
Brief Title
Efficacy and Safety of T-817MA in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or Mild AD
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 24, 2019 (Actual)
Primary Completion Date
February 22, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FUJIFILM Toyama Chemical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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) To evaluate the safety of T-817MA by clinical laboratory tests and adverse events (AEs). To evaluate the pharmacokinetics of T-817MA

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
T-817MA (448 mg)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
T-817MA
Intervention Description
224mg T-817MA orally once daily for first 4 weeks, and then 448mg T-817MA orally once daily for the following weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
The change in the CSF p-tau181 from Baseline to Week 78
Time Frame
Baseline to Week 78
Secondary Outcome Measure Information:
Title
The change in the CSF p-tau181 from Baseline to Week 52
Time Frame
Baseline to Week 52
Title
The change in the CSF p-tau217 from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the CSF total tau from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the CSF neurogranin from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the CSF YKL-40 from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the CSF Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in the plasma NFL from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in cognitive function assessed by CDR-sb and working memory and attention domain as measured by the CFC from Baseline to Weeks 28, 52 and 78
Time Frame
Baseline to Weeks 28, 52 and 78
Title
The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78
Time Frame
Baseline to Weeks 52 and 78
Title
Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs
Time Frame
Screening to Week 82
Title
Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax)
Time Frame
Weeks 16, 28, 40, and 65
Title
Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin)
Time Frame
Weeks 16, 28, 40, and 65
Title
Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h)
Time Frame
Weeks 16, 28, 40, and 65

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
If male, patients must: agree he will not donate sperm during the study and until 104 days after the last dose, AND be required to use highly effective methods of contraception during the study and until 104 days after the last dose If female, patients must: be post-menopausal (i.e. no menses for 12 months without an alternative medical cause) OR be permanently sterilized with methods including hysterectomy, bilateral salpingectomy and bilateral oophorectomy
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 least for 3 months prior to randomization, or not taking any AChE Inhibitors. Key Exclusion Criteria: MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD Taking memantine Any contraindications to lumbar puncture Any contraindications to MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Scheltens, MD, PhD
Organizational Affiliation
VUmc Alzheimer Centrum
Official's Role
Study Director
Facility Information:
Facility Name
FNUSA - Mezinarodni centrum klinickeho vyzkumu
City
Brno
Country
Czechia
Facility Name
FNHK - Neurologicka klinika
City
Hradec Králové
Country
Czechia
Facility Name
A-shine, s.r.o.
City
Plzen
Country
Czechia
Facility Name
CLINTRIAL, s.r.o.
City
Prague
Country
Czechia
Facility Name
VESTRACLINICS, s.r.o.
City
Rychnov
Country
Czechia
Facility Name
Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Facility Name
Klinik für Neurologie Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Klinik und Poliklinik für Neurologie Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Universitätsklinikum Magdeburg Institut für Kognitive Neurologie und Demenzforschung
City
Magdeburg
Country
Germany
Facility Name
Institut für Studien zur Psychischen Gesundheit (ISPG)
City
Mannheim
Country
Germany
Facility Name
Technische Universität München
City
München
Country
Germany
Facility Name
Universitätsklinikum Münster Klinik für Allgemeine Neurologie
City
Münster
Country
Germany
Facility Name
Universitätsmedizin Rostock Zentrum für Nervenheilkunde Klinik für Psychosomatik und Psychotherapeutische Medizin
City
Rostock
Country
Germany
Facility Name
Universitätsklinikum Ulm Studienzentrum Klinik für Neurologie
City
Ulm
Country
Germany
Facility Name
Debreceni Egyetem KK, Pszichiátriai Klinika
City
Budapest
Country
Hungary
Facility Name
Jávorszky Ödön Városi Kórház, Gyógyszertár
City
Debrecen
Country
Hungary
Facility Name
Semmelweis Egyetem, Pszichiátriai és Pszichoterápiás Klinika
City
Győr
Country
Hungary
Facility Name
Semmelweis Egyetem Neurológiai Klinika Gyógyszertára, C földszint
City
Vác
Country
Hungary
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
Tallaght University Hospital.
City
Dublin
Country
Ireland
Facility Name
Brain Research Center Den Bosch
City
's-Hertogenbosch
Country
Netherlands
Facility Name
Brain Research Center
City
Amsterdam
Country
Netherlands
Facility Name
Amphia ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Isala ziekenhuis
City
Zwolle
Country
Netherlands
Facility Name
Hospital General Universitari d' Elx
City
Alicante
Country
Spain
Facility Name
Fundació ACE
City
Barcelona
Country
Spain
Facility Name
Àrea Gestió Documentació Assaigs Clínics-AGDAC Hospital Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico Universitario Virgen de La Arrixaca
City
El Palmar
Country
Spain
Facility Name
CAE Oroitu
City
Getxo
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Victoria Eugenia - Cruz Roja
City
Sevilla
Country
Spain
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
Country
Spain
Facility Name
University of Bath
City
Bath
Country
United Kingdom
Facility Name
Southmead Hospital North Bristol NHS Trust
City
Bristol
Country
United Kingdom
Facility Name
Glasgow memory Clinic
City
Glasgow
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom
Facility Name
Memory Assessment & Research Centre
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Details for sharing data have not been decided yet.

Learn more about this trial

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

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