Alzheimer Disease
Conditions
Brief summary
The main purpose of the study is to assess safety of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer's disease.
Interventions
RADIATIONFlorbetaben
single dose of Florbetaben followed by PET scan
Sponsors
Judit Pich Martínez
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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) * According to the principal investigator, participants must be committed to participate and complete all study procedures. * Has signed the Informed Consent Form voluntarily to participate in the study
Exclusion criteria
* Subjects that 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. * Pregnancy or breast feeding or planned pregnancy during the study period * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease. | At baseline, when FBB-PET is performed. |
| Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination | At baseline, when FBB-PET is performed. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4. | baseline |
| Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers. | baseline |
| Earliest age of positive FBB-PET in FAD mutation carriers. | baseline |
| Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment | baseline |
Countries
Spain
Outcome results
None listed