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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
221
224mg T-817MA orally once daily for first 4 weeks, and then 448mg T-817MA orally once daily for the following weeks.
Placebo once daily
FNUSA - Mezinarodni centrum klinickeho vyzkumu
Brno, Czechia
FNHK - Neurologicka klinika
Hradec Králové, Czechia
A-shine, s.r.o.
Pilsen, Czechia
CLINTRIAL, s.r.o.
Prague, Czechia
VESTRACLINICS, s.r.o.
Rychnov, Czechia
Klinik für Psychiatrie, Psychosomatik und Psychotherapie Universitätsklinikum Frankfurt
The change in the CSF p-tau181 from Baseline to Week 78
Time frame: Baseline to Week 78
The change in the CSF p-tau181 from Baseline to Week 52
Time frame: Baseline to Week 52
The change in the CSF p-tau217 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF total tau from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-42 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF Aβ1-40 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF neurofilament light (NFL) from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF neurogranin from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the CSF YKL-40 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
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
The change in the plasma Aβ1-42 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the plasma Aβ1-40 from Baseline to Weeks 52 and 78
Time frame: Baseline to Weeks 52 and 78
The change in the plasma NFL from Baseline to Weeks 52 and 78
Time frame: 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
Time frame: 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
Time frame: Baseline to Weeks 52 and 78
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
Safety as assessed by the occurrence of AEs, clinical laboratory tests, vital signs, physical examinations, ECGs
Time frame: Screening to Week 82
Population PK analysis of T-817MA with assessment of maximum plasma concentration (Cmax)
Time frame: Weeks 16, 28, 40, and 65
Population PK analysis of T-817MA with assessment of minimum plasma concentration (Cmin)
Time frame: Weeks 16, 28, 40, and 65
Population PK analysis of T-817MA with assessment of total daily exposure (AUC0-24h)
Time frame: Weeks 16, 28, 40, and 65
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Frankfurt, Germany
Klinik für Neurologie Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Klinik und Poliklinik für Neurologie Universitätsklinikum Leipzig
Leipzig, Germany
Universitätsklinikum Magdeburg Institut für Kognitive Neurologie und Demenzforschung
Magdeburg, Germany
Institut für Studien zur Psychischen Gesundheit (ISPG)
Mannheim, Germany
...and 27 more locations