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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Status and phase: Completed; Phase 2

Conditions: Mild Cognitive Impairment

Treatments: Drug: Placebo; Drug: T-817MA

Study type: Interventional

Funder types: Industry

Identifiers

NCT04191486

2018-003567-66 (EudraCT Number)

T817MAEU201

Details and patient eligibility

About

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

Enrollment: 221 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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221 participants in 2 patient groups, including a placebo group

T-817MA (448 mg)

Experimental group

Treatment:

Drug: T-817MA

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo