Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT03834402
Eligibility Criteria:
Inclusion Criteria:
1. age between 50 and 85 years;
2. age and education corrected Mini Mental State Examination score equal or superior to 24/30;
3. Clinical Dementia Rating (CDR) global score of 0.5;
4. concerns about cognitive modifications, expressed as subjective complaints by the subject, or by impression by a close acquaintance or an expert clinician;
5. defective performance with reference to age and education matched controls in one cognitive domain (memory, executive function, attention, language, visuospatial function): if repeated assessments are available, evidence of performance decline;
6. preserved functional autonomy: the subject remains fully independent, even if specific performances may be slower, less efficient than usual level, with occasional errors;
7. no dementia: the cognitive modifications do not significantly hamper social function or work activities.
Exclusion Criteria:
1. history of cerebrovascular disease (i.e. stroke episodes), alcohol abuse, severe medical disorders associated with cognitive impairment (organ failures, endocrine disorders, in particular thyroid disease and B12/folates deficiency); neuroimaging evidence of other potential causes of cognitive decline (e.g. subdural haematoma, malignancy etc.); chronic treatment with psychotropic drugs; women in reproductive age;
2. history of malignancy \< 5 years;
3. contraindications for Magnetic Resonance Imaging (MRI): pacemaker; spinal stimulators; defibrillator; any other condition incompatible with MRI acquisition;
4. presence of spinal malformations or any other contraindications to lumbar puncture, according to the investigator's judgement;
5. HIV infection;
6. use of drugs potentially affecting cognitive function, according to the investigator's judgement;
7. subjects are not allowed to participate in any trial with experimental drug;
Exclusion criteria specific to lumbar puncture:
Patients who refuse to or cannot temporarily interrupt antiplatelet or anticoagulant therapy 14 days prior to sampling visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT03834402
Study Brief:
Protocol Section:
NCT03834402