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Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease

NCT05453539 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-08-13

No results posted yet for this study

Summary

This study is a Phase 1, first-in-human, multi-center study to establish safety of ADx-001 in healthy volunteers, and safety and proof of concept in patients with confirmed amyloid plaques in the brain (confirmed by amyloid positron emission tomography (PET)). ADx-001 is a novel, intravenously delivered, Gd- containing molecularly targeted liposomal product that is being developed for use in contrast-enabled MR imaging of amyloid plaques.

Conditions

  • Alzheimer Disease

Interventions

DRUG

DSPE-DOTA-Gd Liposomal Injection

Single dose, intravenous infusion

Sponsors & Collaborators

  • pharmtrace klinische Entwicklung GmbH

    collaborator UNKNOWN

  • Alzeca Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Sophia Stoecklein · LMU Klinikum

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-09
Primary Completion
2024-11-08
Completion
2024-11-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05453539 on ClinicalTrials.gov