Brain characterization of amyloid protein and glucose metabolism of ALFA project participants

• Conditions: Study to understand factors related with the preclinical stages of Alzheimer's Disease and investigate markers that predict its progression.; MedDRA version: 18.1Level: LLTClassification code 10036654Term: PreventionSystem Organ Class: 100000004865; MedDRA version: 18.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004474-15-ES
• Lead Sponsor: BarcelonaBeta Brain Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-03
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Sign the study informed consent document approved by the corresponding authorities.
2. Men and women enrolled in the ALFA project (STUDY 45-65 FPM/2012).
3. No previous evidence of radiological incidental findings constituting an exclusion criterion as determined by magnetic resonance imaging (MRI).
4. Cognition within psychometrics normal range: MMSE (Mini Mental State Examination) ?26 and Semantic Fluency (animals) ?12.
5. Score of 0 in the CDR scale (Clinical Dementia Rating).
6. Good knowledge of the language and being literate.
7. Female subjects should be post-menopausal or present a negative pregnancy test at the moment of PET scans.
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 390
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Present any cognitive impairment for age and educational level.
2. Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV-TR) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia or bipolar disorder.
3. Individual with visual and/or hearing impairment.
4. History of encephalitis, ictus or seizures excluding feverish convulsions during childhood.
5. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI).
6. Any contraindication to MRI examination, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician.
7. Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
8. Clinically relevant renal or hepatic insufficiency.
9. Any other condition clinically important condition that may jeopardize the study or is dangerous for the subject.
10. Active drug or alcohol abuse.
11. Presence of pacemaker, aneurysm graft, artificial heart valves, auditory implants, cerebral shunts, metal fragments or strange objects in the eyes, skin or body that may be contraindicate magnetic resonance imaging.
12. Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG.
13. Being pregnant or breast feeding.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the prevalence of a positive 18F-Flutemetamol scan in the individuals recruited in the ALFA project according to age, APOE4 and familiar history of AD.;Secondary Objective: To study the prevalence of the different stages of preclinical AD in the individuals recruited in the ALFA project according to age, APOE4 and familiar history of AD.;Primary end point(s): A? protein deposition detected by in vivo PET imaging using 18F-Flutemetamol as radiotracer. 18F-Flutemetamol scans will be categorized as either positive or negative according to the standardized uptake value ratio.;Timepoint(s) of evaluation of this end point: As a cross-sectional study, the primary endpoint will only evaluated once.