Healthy volunteers and Mild Cognitive Impaired patients
Conditions
Interventions
Product Name: Flutemetamol (18F) Injection
Product Code: Flutemetamol (18F) Injection
Pharmaceutical Form: Solution for injection
CAS Number: 765922-62-1
Concentration unit: MBq/ml megabecquerel(s)/mi
Sponsors
Cliniques Universitaires Saint Luc - UCL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Healthy elderly people, cognitively intact. - Mild Cognitive Impaired patients 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120
Exclusion criteria
Exclusion criteria: - Significant neurological of psychiatric history and/or significant pathological lesions on MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate with a multimarker approach the aMCI patients by quantitative analysis of each biomarkers by comparison to a normal database of recruited healthy volunteers. ;Secondary Objective: establish a common database of healthy volunteers with each biomarkers;Primary end point(s): - To estimate the increased discriminatory power of combination of different biomarkers in comparison to each isolated marker to identify patients at risk to convert to Alzheimer disease.;Timepoint(s) of evaluation of this end point: depending on the rate of inclusion > intermediate analysis every year until the end of the inclusion. Final analysis at the end of the clinical follow up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Build a control group (database of normal Flutemetamol F18 scans) based on the recruitment of healthy volunteers aged from 60 to 80 years old ;Timepoint(s) of evaluation of this end point: At the end the the healthy volunteers inclusion period (control group) | — |
Countries
Belgium
Contacts
Public ContactNuclear Medicine dpt - Dr R.Lhommel
Cliniques Universitaires Saint Luc
Outcome results
None listed