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

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ClinicalTrials.gov Identifier: NCT02362880
Recruitment Status : Recruiting
First Posted : February 13, 2015
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Judit Pich Martínez, Fundacion Clinic per a la Recerca Biomédica

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Radiation: Florbetaben Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease: 18F-Florbetaben Positron Emission Tomography Study
Study Start Date : February 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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. ]
  2. Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination [ Time Frame: At baseline, when FBB-PET is performed. ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362880


Contacts
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Contact: Raquel Sánchez +34932275400 ext 5785 RSANCHEZ@clinic.ub.es

Locations
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Spain
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Raquel Sánchez, MD    932275400 ext 5785    RSANCHEZ@clinic.ub.es   
Sponsors and Collaborators
Judit Pich Martínez
Investigators
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Principal Investigator: Raquel Sánchez Hospital Clínic de Barcelona

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Responsible Party: Judit Pich Martínez, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT02362880     History of Changes
Other Study ID Numbers: FBB-FAD-2014
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders