Subjects with subjective cognitive decline. MedDRA version: 19.0 Level: LLT Classification code 10032831 Term: Other specified non-arthropod-borne viral diseases of central nervous system System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Neuraceq solution for injection Florbetaben (18F) 300 Mbq/ml
Product Name: Neuraceq 300 MBq/ml solución inyectable
Pharmaceutical Form: Solution for injecti
Sponsors
Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. According to the principal investigator, participants must be committed to participate and complete all study procedures. 2. The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern. 3. Age >/= 60*. 4. MMSE cutoff for inclusion will be = 26. 5. CDR=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Subjects those are not able to complete the study. 2. 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). 3. Current or previous history of alcohol abuse or epilepsy. 4. Allergic to Florbetaben or any of its constituents. 5. Multiple drug allergies and/or previous history of contrast allergy. 6. 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). 7. Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure. 8. Pregnancy or breast feeding or planned pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess safety of a single dose of FBB followed by PET scan in individuals with subjective cognitive decline (SCD). 2. To determine the number of SCD subjects with positive visual FBB-PET scan. ; Secondary Objective: 1. To determine the number of SCD subjects with positive standardized uptake value ratios (SUVRs) of FBB-PET scan. 2. To explore the cortical pattern of amyloid deposition in SCD subjects. ; Primary end point(s): 1. Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with SCD. 2. Proportion of SCD subjects that present positive uptake after FBB-PET through visual examination. ; Timepoint(s) of evaluation of this end point: 1. SUSARs, SAEs, death. 2. Proportion of FBB-PET with positive result through visual examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4. 2. The cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination. ; Timepoint(s) of evaluation of this end point: 1. Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4. 2. The cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination. | — |
Countries
Spain
Contacts
Public ContactFarmacologia clinica
CTU CLINIC (Clinical Trial Unit)
Outcome results
None listed