Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study

Not Applicable

Terminated

• Conditions: Alzheimer Disease

• Registration Number: NCT02362880
• Lead Sponsor: Judit Pich Martínez

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain