Ad

This is a multicenter, randomized, double-blind, placebo-controlled parallel Phase II core period study to evaluate the efficacy and safety of TTYP01 Tablets in early symptomatic AD (Mild cognitive impairment \[MCI\] due to AD, or mild AD dementia). A total of 180 participants will be randomized into 3 parallel groups: 2 TTYP01 dose groups and 1 placebo group.

Alzheimer's disease (AD) and frontotemporal dementia (FTD) are the most common forms of neurodegenerative dementia. However, their differential and timely diagnosis can be challenging for clinicians, therefore often closing the door for an early and possibly successful treatment before irreversible cerebral damage occurs. Hence, treatment options often become available only at a late point in time. In Alzheimer's disease, early neuroimaging markers are glucose hypometabolism and Amyloid-/Tau-depositions (PET). Recent findings from sodium magnetic resonance imaging (23Na-MRI) point to brain tissue sodium concentration as a metabolic marker of AD progression. Sodium is crucial for neurotransmission and cellular homeostasis maintained by the cellular Na+/K+-ATPase, depending on Adenosine-Triphosphate as energy source from the mitochondrial respiratory chain, also interacting with tau and amyloid. In this project, we aim to characterize disease-specific metabolic patterns in AD vs. FTD by performing 23Na-MRI in association to FDG-PET to support early positive and differential diagnosis and therapeutic follow-up in both diseases in association to clinical parameters such as CSF/blood markers and neuropsychological assessment. Assessment of 7T MRI including 23Na-MRI, 31P-MRS and 1H-MRI is planned with analysis of results in association with FDG-PET, Amyloid- and Tau-PET, blood and CSF biomarkers as well as neuropsychological and clinical assessment.

The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD 1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD; 2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation; 3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions; 4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients.