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Drug Development.

Jorge J Llibre-Guerra1, Jin Zhou2, Lon S S Schneider3,4,5

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Summary
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Dominantly Inherited Alzheimer's disease (DIAD) trial baseline data show similar characteristics between symptomatic and asymptomatic groups. This provides a foundation for evaluating anti-tau therapy etalanetug in DIAD patients.

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Area of Science:

  • Neuroscience
  • Genetics
  • Clinical Trials

Background:

  • Dominantly Inherited Alzheimer's disease (DIAD) is a rare form of Alzheimer's disease (AD) with early onset (30-50 years) and shared pathophysiology with sporadic AD.
  • DIAD affects approximately 1% of AD cases but offers insights into potential treatments for all forms of AD.
  • The Dominantly Inherited Alzheimer Network - Trials Unit (DIAN-TU) aims to develop treatments for DIAD, potentially applicable to broader AD populations.

Purpose of the Study:

  • To describe the baseline characteristics of participants in the DIAN-TU-001 Tau NexGen trial.
  • To evaluate the safety, tolerability, and efficacy of the anti-tau therapy etalanetug in combination with lecanemab for DIAD.
  • To assess the impact of etalanetug on cognitive/clinical progression and disease-related biomarkers in both symptomatic and asymptomatic DIAD populations.

Main Methods:

  • DIAN-TU-001 is a phase II/III multicenter, randomized, double-blind, placebo-controlled platform trial.
  • The trial utilizes biomarker, cognitive, and clinical endpoints to assess investigational therapies in individuals with AD-causing mutations.
  • Baseline characteristics were summarized descriptively for two cohorts: symptomatic (CDR=0.5-1) and asymptomatic (CDR=0) DIAD participants.

Main Results:

  • 243 participants were screened, and 197 were randomized into the DIAN-TU-001 Tau NexGen trial (Cohort 1: 97; Cohort 2: 100).
  • Baseline characteristics were similar between symptomatic (Cohort 1) and asymptomatic (Cohort 2) groups, with expected variations in cognitive scores.
  • Mean age was 47.8 years (Cohort 1) and 43.4 years (Cohort 2); mean CDR-SB scores were 3.7 (Cohort 1) and 0.1 (Cohort 2).
  • APOE4 carrier frequency and PSEN1 gene type prevalence were consistent with expectations for the DIAD population.

Conclusions:

  • The baseline characteristics of the DIAN-TU-001 Tau NexGen trial align with the clinical profiles of asymptomatic and symptomatic DIAD.
  • The data confirm general consistency between the symptomatic and asymptomatic cohorts, with notable differences in clinical and cognitive assessments.
  • These findings establish a robust foundation for the ongoing evaluation of anti-tau therapies in DIAD.