Study of the uptake pattern of 18F-Florbetaben in Positron Emission Tomography in healthy volunteers carrying genetic mutations in Alzheimer´s disease-related genes.

Phase 1

• Conditions: Healthy voulnteers carrying a mutation in at least one of the following genes: PSEN1, PSEN2 or APP.; MedDRA version: 17.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-000763-41-ES
• Lead Sponsor: FUNDACIÓ CLÍNIC PER A LA RECERCA BIOMÈDICA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-22
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. 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)
2. According to the principal investigator, participants must
be committed to participate and complete all study
procedures.
3. Has signed the Informed Consent Form voluntarily to
participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects that are not able to complete the study.
2. 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)
3. Current or previous history of alcohol abuse or epilepsy
4. Allergic to Florbetaben or any of its constituents
5. Multiple drug allergies and/or previous history of contrast
allergy.
6. Pregnancy or breast feeding or planned pregnancy during
the study period
7. 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)
8. Evidence for any other neurological or psychiatric disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified