Clinical trial NCT02362880: Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study
Official title: Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease: 18F-Florbetaben Positron Emission Tomography Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease.
timeFrame: At baseline, when FBB-PET is performed.
measure: Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination
timeFrame: At baseline, when FBB-PET is performed.
Secondary outcomes:
measure: Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
timeFrame: baseline
measure: Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers.
timeFrame: baseline
measure: Earliest age of positive FBB-PET in FAD mutation carriers.
timeFrame: baseline
measure: Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment
timeFrame: baseline
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Raquel Sánchez
role: PRINCIPAL_INVESTIGATOR
References: