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Completed

NCT Number: NCT04191486

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

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

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

FNUSA - Mezinarodni centrum klinickeho vyzkumu, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-817MA

Drug

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

Placebo

Drug

Placebo once daily

Primary outcomes

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

    Time frame: Baseline to Week 78

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

FUJIFILM Toyama Chemical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2019
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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