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

• Status: Unknown status
• Trial end date: 2019-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

Criteria

Inclusion Criteria:

• 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

• Mini-Mental State Examination cutoff for inclusion will be ≥ 26.

• Clinical Dementia Rating <0,5.

• Subjects must have signed the Informed Consent Form voluntarily to participate in the study.

Exclusion Criteria:

• 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.