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

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.

Timeline

Start

2022-11-09

Primary completion

2024-11-08

Completion

2024-11-08

Outcome

Outcome not reported

Stopped (Enrollment): “A temperature excursion occurred at the drug supplier's storage facility, which led to the loss of a significant portion of the IMP stock. Consequently, there is not enough IMP available to support continued recruitment”

Drugs

Indications