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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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mutation carrier

Group Type ACTIVE_COMPARATOR

Florbetaben

Intervention Type RADIATION

single dose of Florbetaben followed by PET scan

mutation non-carrier

Group Type SHAM_COMPARATOR

Florbetaben

Intervention Type RADIATION

single dose of Florbetaben followed by PET scan

Interventions

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Florbetaben

single dose of Florbetaben followed by PET scan

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes