drugset / Trial / NCT03057938

Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study

NCT03057938

NaSingle-groupOpen-labelPrevention

Summary

Phase II, open-label clinical trial with a medicinal product. A total of 30 subjects will be included in the study. All participants will receive a single intravenous dose of 300 MBq of FBB. A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of FBB. The present proposal aims are: to assess safety of a single dose of FBB followed by PET scan in individuals with subjective cognitive decline (SCD), to determine the number of SCD subjects with positive visual FBB-PET scan, to determine the number of SCD subjects with positive standardized uptake value ratios (SUVRs) of FBB-PET scan and to explore the cortical pattern of amyloid deposition in SCD subjects.

Timeline

Start
2020-07
Primary completion
2022-01
Completion
2022-06

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-Florbetaben Diagnostic / imaging agent 300 mbq Intravenous