Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease

What Was Tested

This registered early phase 1 trial tested Amylin (Islet Amyloid Polypeptide).

In this multi-center study, the investigators plan to develop a simple blood-based test for early detection of Alzheimer's disease (AD).

The test is based on a single injection of Pramlintide, an amylin analogue and FDA-approved drug currently used for treatment of diabetes.

The investigative team has provided evidence in humans with full-blown AD and AD-relevant mouse models that a single injection of Pramlintide transiently renders the blood brain barrier (BBB) more permeable to Amyloidbeta (Aß) peptides, allowing their efflux from the brain compartment into the blood.

It had three arms (groups): Probable AD (experimental), Amnestic MCI (active comparator) and Control- Normal Cognition (active comparator).

Participants with normal cognition without any memory complaints will receive the pramlintide challenge test.

The registry classes the interventions as drug.

Who Took Part

The registry lists 57 actual participants took part.

It was open to people of any sex aged from 60 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A consensus diagnosis of probable Alzheimer's Disease (AD), amnestic mild cognitive impairment (MCI), or control. BMI of 20-35. Probable AD subjects must be confirmed for positive AD pathology in the central nervous center (CNS0. Probable AD subjects must have a designated research proxy signed before they became demented.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: diabetes mellitus; use of insulin, pramlintide, other injectable anti-hyperglycemic agents, such as glucagon like peptide-1 (glp-1), or oral anti-diabetic products; history of stroke.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Amylin (Islet Amyloid Polypeptide) group and the comparison group ran side by side rather than switching.

Everyone knew when Amylin (Islet Amyloid Polypeptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-02-04 with completion listed for 2026-11.

It ran at 3 sites in United States (3).

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Plasma Aβ 1-40 levels (time frame: baseline, 5, 30, 60, and 180 min after challenge test). Plasma Aβ1-42 levels (time frame: baseline, 5, 30, 60, and 180 min after challenge test). Plasma Aβ and t-tau changes (time frame: baseline, 5, 30, 60, and 180 min after challenge test).

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Amylin (Islet Amyloid Polypeptide) in 57 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.