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Clinical Phase IINIH / NIAPrincipal Investigator

EMRAST

Early Multi-Modal Alzheimer's Risk Assessment & Sensing Technology

Multimodal diagnostic platform combining psychophysical olfactory stimulation with ML-based biomarker classification for pre-clinical Alzheimer's detection. Randomized feasibility trial published in Alzheimer's & Dementia.

$2.95MR44AG082621

Project Facts

Role
Principal Investigator
Phase
Phase II
Status
Clinical Validation
Funding
$2.95M
Grant Number
R44AG082621
Agency
NIH / NIA

NIH Award History

$449KPhase I2023

1R44AG082621-01

$1.25MPhase II2024

4R44AG082621-02

$1.25MPhase II2025

5R44AG082621-03

Engineering Challenges

  • Designing calibrated, reproducible olfactory stimulus delivery across diverse clinical environments
  • Integrating multi-modal physiological sensing within a standardized clinical workflow
  • Developing ML classification models robust to real-world measurement variability
  • Building FDA Design History File architecture alongside rapid iterative development
  • Ensuring patient compliance across populations with varying cognitive status

Technology Domains

BioelectronicsMachine LearningFDA 21 CFR 820ISO 13485Signal ProcessingHIPAA Architecture

Intellectual Property

Alzheimer's & Dementia: TR&CI

Randomized feasibility clinical trial (Article TRC270226)

View reference →