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NCT03560960 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Boston University.

Active
Registry status
Early Phase 1
Development phase
57
Enrollment target
3
Study locations

NCT03560960 is a Early Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment that is active but no longer recruiting, run by Boston University. The registered enrollment target is 57 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT03560960, a Early Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, is active but no longer recruiting, sponsored by Boston University.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
57 participants
Enrollment target
3
Study locations

Study 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 biomarker (i.e., at the Mild Cognitive Impairment (MCI) stage), 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 participants 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.

Conditions Studied

Alzheimer Disease Mild Cognitive Impairment

Interventions

  • DRUG Pramlintide challenge test

Study Locations (3)

Massachusetts

  • BU Alzheimer Disease Center - Boston
  • Memory Center VA Boston Healthcare - Jamaica Plain

Indiana

  • Indiana University Alzheimer Disease Center - Indianapolis

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2020-02-04
Est. Completion 2026-11
Phase Early Phase 1

Sponsor

Boston University

185 total trials

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What the Registry Record Tells You About NCT03560960

The ClinicalTrials.gov registry entry for NCT03560960 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which Pramlintide challenge test is the first listed.

NCT03560960 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Indiana.

Frequently Asked Questions

What is clinical trial NCT03560960 about?

NCT03560960 is a clinical study titled "Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease". 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 h...

What is the current status of trial NCT03560960?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 57 participants. The study started on 2020-02-04. Estimated completion is 2026-11.

What conditions does trial NCT03560960 study?

This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment.

What interventions are being tested in trial NCT03560960?

The interventions under investigation include: Pramlintide challenge test (DRUG).

Who is sponsoring clinical trial NCT03560960?

This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03560960 being conducted?

This trial has 3 study locations across Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.