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

NCT02362880 | Terminated

• 1 other identifier: FBB-FAD-2014
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

mutation carrier

ACTIVE COMPARATOR

Radiation: Florbetaben

mutation non-carrier

SHAM COMPARATOR

Radiation: Florbetaben

Interventions

Florbetaben RADIATION

single dose of Florbetaben followed by PET scan

mutation carrier; mutation non-carrier

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Judit Pich Martínez: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Raquel Sánchez

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

ES (1)