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

NCT03057938 | Withdrawn Phase 2

• 1 other identifier: Euro-SCD-FBB2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Subjective Cognitive Decline

Keywords

Alzheimer; Subjective Cognitive Decline; Florbetaben

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events

  Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with Subjective Cognitive Decline

  24 months

• Positive visual FBB-PET scan

  Proportion of Subjective Cognitive Decline subjects that present positive uptake after FBB-PET through visual examination.

  24 months

Secondary Outcomes (2)

• Positive standardized uptake value ratios

  24 months

• Cortical pattern of amyloid deposition

  24 months

Study Arms (1)

18F-Florbetaben (FBB)

EXPERIMENTAL

18F-Florbetaben

Drug: 18F-Florbetaben (FBB)

Interventions

18F-Florbetaben (FBB) DRUG

All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.

Also known as: FBB

18F-Florbetaben (FBB)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be committed to participate and complete all study procedures.
• The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
• Age ≥ 60
• Clinical Dementia Rating \<0,5.
• Subjects must have signed the Informed Consent Form voluntarily to participate in the study.

You may not qualify if:

• Subjects those are not able to complete the study.
• Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ≥ 5 x ULN) or advanced renal insufficiency (creatinine ≥ 2 x ULN).
• Current or previous history of alcohol abuse or epilepsy.
• Allergic to Florbetaben or any of its constituents.
• Multiple drug allergies and/or previous history of contrast allergy.
• Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function).
• Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure.
• Pregnancy or breast feeding or planned pregnancy during the study period.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

MeSH Terms

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Study Officials

• Lorena Rami, Dr

  Fundació Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Model Details: Phase II, open-label clinical trial with a medicinal product.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: July 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 12, 2025

Record last verified: 2024-03