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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02362880
• Other study ID #: FBB-FAD-2014
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: January 2019

Study information

• Verified date: April 2021
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Radiation:
• Florbetaben
single dose of Florbetaben followed by PET scan

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Judit Pich Martínez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination		At baseline, when FBB-PET is performed.
Secondary	Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.		baseline
Secondary	Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers.		baseline
Secondary	Earliest age of positive FBB-PET in FAD mutation carriers.		baseline
Secondary	Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment		baseline