# Multi-center development of a novel diagnostic test for Alzheimer's disease

> **NIH NIH R01** · BOSTON UNIVERSITY MEDICAL CAMPUS · 2021 · $1,275,411

## Abstract

Summary
As the number of Alzheimer's disease (AD) patients increases rapidly, a simple and specific blood test to
diagnose AD is needed. Our recent research discovered that a single peripheral injection of pramlintide can
move amyloid-β peptide (Aβ) from the brain into the blood in AD mouse models, and the level of Aβ increase
in the blood correlates well with the existing amount of Aβ in the brain. Based on this finding, the proposed
study is to further the development of a blood test for AD patients that we initiated by a single injection of
pramlintide as the challenge for biomarker changes in blood. This challenge test will be a diagnostic test for
AD similar in principle to the glucose tolerance test that shows abnormalities specifically in diabetic patients.
The central hypothesis is that a single pramlintide injection will significantly induce a change in a
group of AD-related factors in the blood of AD patients but not in those with normal cognition, and
the signature of these changes will correlate with the AD biomarkers in the central nervous system
(CNS). We will recruit 240 subjects from 3 clinical research centers to conduct the pramlintide challenge test.
There will be three specific aims. Aim 1 is to investigate whether a single injection of pramlintide induces a
dose-dependent increase in Aβ in the blood of AD patients. Aim 2 is to investigate whether the pattern of AD
biomarker changes in the pramlintide challenge test correlates with AD biomarkers in CSF. Aim 3 is to
determine whether the pattern of AD biomarker changes in the pramlintide challenge test correlate with
amyloid burden in the brain. Pramlintide is non-amyloidogenic amylin analog, and is an FDA-approved drug
for diabetes with a favorable safety profile. Should our proposed study support the concept of the amylin
challenge test as a diagnostic test for AD, this test will be able to be conducted in a doctor's office.
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## Key facts

- **NIH application ID:** 10190762
- **Project number:** 5R01AG059424-04
- **Recipient organization:** BOSTON UNIVERSITY MEDICAL CAMPUS
- **Principal Investigator:** Martin Rhys Farlow
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,275,411
- **Award type:** 5
- **Project period:** 2018-09-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10190762

## Citation

> US National Institutes of Health, RePORTER application 10190762, Multi-center development of a novel diagnostic test for Alzheimer's disease (5R01AG059424-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10190762. Licensed CC0.

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