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

J

Judit Pich Martínez

Status

Terminated

Conditions

Alzheimer Disease

Treatments

Radiation: Florbetaben

Study type

Interventional

Funder types

Other

Identifiers

NCT02362880
FBB-FAD-2014

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

32 participants in 2 patient groups

mutation carrier
Active Comparator group
Treatment:
Radiation: Florbetaben
mutation non-carrier
Sham Comparator group
Treatment:
Radiation: Florbetaben

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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