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

April 9, 2021 updated by: Judit Pich Martínez

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mutation carrier
Radiation: Florbetaben
single dose of Florbetaben followed by PET scan
Sham Comparator: mutation non-carrier
Radiation: Florbetaben
single dose of Florbetaben followed by PET scan

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: At baseline, when FBB-PET is performed.
At baseline, when FBB-PET is performed.
Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination
Time Frame: At baseline, when FBB-PET is performed.
At baseline, when FBB-PET is performed.

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
Time Frame: baseline
baseline
Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers.
Time Frame: baseline
baseline
Earliest age of positive FBB-PET in FAD mutation carriers.
Time Frame: baseline
baseline
Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Judit Pich Martínez

Investigators

  • Principal Investigator: Raquel Sánchez, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

February 9, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FBB-FAD-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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