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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2021
• Main ID: NCT02362880
• Date of registration: 09/02/2015
• Prospective Registration: No
• Primary sponsor: Judit Pich Martínez
• Public title: Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study
• Scientific title: Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease: 18F-Florbetaben Positron Emission Tomography Study
• Date of first enrolment: February 2015
• Target sample size: 32
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02362880
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Raquel Sánchez
• Affiliation: Hospital Clínic de Barcelona

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Alzheimer Disease

Intervention(s)

Radiation: Florbetaben

Primary Outcome(s)

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

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.]

Secondary Outcome(s)

Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers. [Time Frame: baseline]

Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment [Time Frame: baseline]

Earliest age of positive FBB-PET in FAD mutation carriers. [Time Frame: baseline]

Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4. [Time Frame: baseline]

Secondary ID(s)

FBB-FAD-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors