- concern for a cognitive change, expressed by the subject as subjective disorder or as an impression by a person who knows deeply the subject or an expert clinician;
- impaired performance compared to that expected for the subject’s age and education, in one or more cognitive domains (memory, executive functions, attention, language, visuospatial functions), if repeated evaluations are available, presence of decline;
- Spared autonomy in functional abilities: even if performance may be slower, less efficient and with some error, the subject remains substantially independent;
- not demented: cognitive changes are not significantly affecting the subject’s social functioning or work activities.
- History of cerebrovascular disease;
- Previous major head injury with loss of consciousness;
- internal diseases associated with cognitive impairment (i.e. organ failure, endocrine pathologies);
- chronic treatment with drugs that in the judgment of the Recruiter Doctor may interfere with the diagnosis of MCI.
The study plan
The study aims to recruit subjects with MCI and to evaluate the clinical characteristics as well as the biomarkers results, at the beginning of the study and to follow the evolution for three years.
The participation of each subject in the study will last for 42 months.
During this period each participant will undergo to periodic visits to the chosen Recruiter Center.
After the first visit, each participant will be evaluated every 6 months.
It will also be possible to contact the doctor even outside the scheduled visits, if necessary.
For the entire duration of the study, participants will NOT be allowed to enter clinical trials with experimental drugs.
At the beginning of the study, after completing the pre-screening phase, the following exams will be performed:
- neuropsychological tests (MMSE Mini mental state examination, and DRF delayed-free recall – FCSRT Free and Cued Selective Reminding Test);
- functional neuroimaging with (18F) FDG-PET;
- structural neuroimaging (magnetic resonance imaging with hippocampal volume)
- levitation of liquor (by lumbar puncture) for beta-amyloid and Tau metabolites;
- blood collection for APOE4 genetic test;
- electroencephalography for the study of brain connectivity.
In addition, a neuropsychological visit, a clinical visit and a blood pressure measurement will be performed.
Moreover, at the beginning and during the study, each participant will undergo a series of ambulatory neuropsychological tests lasting approximately 90 minutes.
Questions will be asked about the symptoms of the disease and a request of performing some simple activities will be done during these tests.
The results of these tests will help us to evaluate the initial state and the stability of the MCI condition or the eventual progression towards a real disease condition.