Healthy voulnteers carrying a mutation in at least one of the following genes: PSEN1, PSEN2 or APP. MedDRA version: 17.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Neuraceq
Product Name: Neuraceq
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: FLORBETABEN (18F)
Sponsors
FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult children (> 18 yo) of genetic Alzheimer?s disease patients with a known mutation in PSEN1, APP o PSEN2 genes and who are either cognitively normal (CDR=0) or have mild symptoms of cognitive decline (CDR 0.5 or 1) 2. According to the principal investigator, participants must be committed to participate and complete all study procedures. 3. Has signed the Informed Consent Form voluntarily to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects that 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. Pregnancy or breast feeding or planned pregnancy during the study period 7. 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) 8. Evidence for any other neurological or psychiatric disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess safety of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease. 2. To determine the number of Familiar Alzheimer´s disease (FAD) mutation carriers with positive FBB-PET at visual assessment. ; Secondary Objective: 1. To determine the number of FAD mutation carriers with abnormally high standardized uptake value ratios (SUVRs) of FBB-PET scan. 2. To compare global SUVR scores of FBB-PET scan between mutation carriers and non-carriers. 3. To study the earliest age of FAD mutations carriers with positive FBB-PET scan at visual assessment. 4.-To explore the cortical pattern of amyloid deposition in FAD mutations carriers ; Primary end point(s): 1. Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease. 2. Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination ;Timepoint(s) of evaluation of this end point: At baseline, when FBB-PET is performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4. 2. Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers. 3. Earliest age of positive FBB-PET in FAD mutation carriers. 4. Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment ;Timepoint(s) of evaluation of this end point: at baseline | — |
Countries
Spain
Contacts
Public ContactRaquel Sánchez-Valle
FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA
Outcome results
None listed