Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
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. This Aß efflux causes a corresponding transient
elevation of blood levels of Aß, the magnitude of which the applicants believe is
proportional to the brain amyloid load as determined by AV-45 PET. The measured difference in
the level of plasma Aß taken just before and a short time after injection should reveal the
magnitude of the transient increase in blood Aß levels. Supportive preliminary data comes
from later stage (full-blown) AD patients with more in-depth background studies in Tg2576 and
5X Familial Alzheimer's Disease (FAD) mouse models. If successful for use as an early AD
(i.e., at the Mild Cognitive Impairment [MCI] stage) biomarker, this could be a game-changer
for both early AD diagnostics and clinical trials aimed at identifying and testing the
efficacy of drugs useful for treatment of AD at early stages. If Pramlintide is effective in
releasing mobile pools of Aß from the brain into the blood, this could also have some
therapeutic potential, with the goal of reducing brain amyloid load.
Three groups of particpants will be studied: 1) amnestic MCI with or without positive AD
imaging pathology, 2) probable AD with positive imaging AD pathology, and 3) controls who
have normal cognition and do not have memory complaints.