# Rapid saliva test for noninvasive diagnostic screening of MCI and dementia

> **NIH NIH R44** · GAIA MEDICAL INSTITUTE, INC. · 2023 · $1,302,154

## Abstract

Project Summary Rapid saliva test for noninvasive diagnostic screening of MCI and dementia
In 2020, over 6.2 million Americans had dementia costing the nation $355 billion. There is unmet need for a
standardized, cost-effective test for diagnostic screening of Mild cognitive impairment (MCI) and Alzheimer’s
disease (AD) to move towards early detection and treatment of dementia to reduce disease burden and costs.
The goal of this SBIR project is to develop a rapid saliva test for diagnosis of MCI and AD. Phase I showed
feasibility of key innovations: standardized saliva methods, validated biomarker assays, 10 candidate
biomarkers of MCI and AD and a new saliva cartridge for commercial Lateral Flow Immunoassay (LFA). The
proposed Phase II study will clinically validate a diagnostic biomarker of MCI and AD biomarker in older adults
and develop a prototype device to show feasibility of the commercial product. SA1 will enroll N=400 males and
females age ≥50 at 2 sites: N=200 AD, N=100 MCI and N=100 cognitively normal controls (CN). Participants
will be assigned to the cohorts based on a gold standard clinical and neurocognitive evaluation. The cohorts
will be matched on important demographics and clinical characteristics. The proposed sample size is estimated
to provide ≥80% statistical power with 95% error margin. N=550 saliva samples will be collected: 1 sample
from all AD, MCI and 70 CN and 6 serial samples from 30 CN. SA2 will measure the 10 candidate biomarkers
in N=550 saliva samples from SA1. Statistical modeling of Training set (N=300) will utilize both statistical and
machine learning methods to select a composite biomarker and a cutoff based on diagnostic performance for
MCI and AD. Potential demographic and clinical covariates will be included in the statistical model. The
selected biomarker and cutoff will be validated using clinically and demographically matched Validation set
(N=100) based on targeted milestones for diagnostic accuracy, sensitivity and specificity. Serial samples from
CN will define the normal range of biomarker concentration and biological variability. SA3 will demonstrate a
prototype LFA device for the MCI-AD biomarker validated in SA2. Expected Outcomes: Results of the Phase
II study will rigorously clinically validate a new saliva biomarker for diagnosis of MCI and AD. Large and
representative sample size (400 subjects across MCI and AD phenotype and stage, age, sex and geography)
will provide statistically significant, generalizable clinical data. Standardized preanalytical saliva handing and
analytically validated assays will provide accurate and reliable biomarker data. Prototype device will show
technical feasibility of the commercial test. Overall, this project has a high potential for a wide-ranging impact
on clinical AD care by providing an objective, noninvasive and clinically feasible biological biomarker for
diagnosis of AD and MCI, and translating this innovation into a standardized, scalable and cost-effe...

## Key facts

- **NIH application ID:** 10652613
- **Project number:** 5R44AG078044-02
- **Recipient organization:** GAIA MEDICAL INSTITUTE, INC.
- **Principal Investigator:** Mark Ettenhofer
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,302,154
- **Award type:** 5
- **Project period:** 2022-07-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10652613

## Citation

> US National Institutes of Health, RePORTER application 10652613, Rapid saliva test for noninvasive diagnostic screening of MCI and dementia (5R44AG078044-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10652613. Licensed CC0.

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