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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

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ClinicalTrials.gov Identifier: NCT04191486
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
FUJIFILM Toyama Chemical Co., Ltd.

Study Description
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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:

  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

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: T-817MA Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 24, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: T-817MA (448 mg) 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.
Placebo Comparator: Placebo Drug: Placebo
Placebo once daily


Outcome Measures
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Primary Outcome Measures :
  1. The change in the CSF p-tau181 from Baseline to Week 78 [ Time Frame: Baseline to Week 78 ]

Secondary Outcome Measures :
  1. The change in the CSF p-tau181 from Baseline to Week 52 [ Time Frame: Baseline to Week 52 ]
  2. The change in the CSF p-tau217 from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  3. The change in the CSF total tau from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  4. The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  5. The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  6. The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  7. The change in the CSF neurogranin from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  8. The change in the CSF YKL-40 from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  9. 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 ]
  10. The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  11. The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  12. The change in the plasma NFL from Baseline to Weeks 52 and 78 [ Time Frame: Baseline to Weeks 52 and 78 ]
  13. 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 ]
  14. 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 ]
  15. 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 ]
  16. Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs [ Time Frame: Screening to Week 82 ]
  17. Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax) [ Time Frame: Weeks 16, 28, 40, and 65 ]
  18. Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin) [ Time Frame: Weeks 16, 28, 40, and 65 ]
  19. Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h) [ Time Frame: Weeks 16, 28, 40, and 65 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

If male, patients must:

  1. agree he will not donate sperm during the study and until 104 days after the last dose, AND
  2. be required to use highly effective methods of contraception during the study and until 104 days after the last dose

If female, patients must:

  1. be post-menopausal (i.e. no menses for 12 months without an alternative medical cause) OR
  2. be permanently sterilized with methods including hysterectomy, bilateral salpingectomy and bilateral oophorectomy
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191486


Contacts
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Contact: Larah de Groot (for recruitment) +31 30 656 9186 larah.degroot@juliusclinical.com
Contact: Tomohiro Okuda (for drug information) fftc-clinicaltrial-info1@fujifilm.com

Locations
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Sponsors and Collaborators
FUJIFILM Toyama Chemical Co., Ltd.
Investigators
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Study Director: Philip Scheltens, MD, PhD VUmc Alzheimer Centrum
More Information
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Responsible Party: FUJIFILM Toyama Chemical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04191486    
Other Study ID Numbers: T817MAEU201
2018-003567-66 ( EudraCT Number )
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Details for sharing data have not been decided yet.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders