Status:
COMPLETED
INTERCEPTOR Project: From MCI to Dementia
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborating Sponsors:
Ministry of Health, Italy
Agenzia Italiana del Farmaco
Conditions:
Mild Cognitive Impairment
Alzheimer Disease
Eligibility:
All Genders
50-85 years
Brief Summary
In the next years a number of phase 2-3 trials which utilize experimental drugs possibly disease modifying for Alzheimer Dementia will reach their conclusion. This dense clinical trials activity has t...
Detailed Description
In the next 8 years a number of phase 2-3 trials will end up which utilize experimental drugs possibly disease modifying for Alzheimer Dementia. They target different disease stages: mild-moderate AD,...
Eligibility Criteria
Inclusion
- age between 50 and 85 years;
- age and education corrected Mini Mental State Examination score equal or superior to 24/30;
- Clinical Dementia Rating (CDR) global score of 0.5;
- concerns about cognitive modifications, expressed as subjective complaints by the subject, or by impression by a close acquaintance or an expert clinician;
- 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;
- preserved functional autonomy: the subject remains fully independent, even if specific performances may be slower, less efficient than usual level, with occasional errors;
- no dementia: the cognitive modifications do not significantly hamper social function or work activities.
Exclusion
- 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;
- history of malignancy \< 5 years;
- contraindications for Magnetic Resonance Imaging (MRI): pacemaker; spinal stimulators; defibrillator; any other condition incompatible with MRI acquisition;
- presence of spinal malformations or any other contraindications to lumbar puncture, according to the investigator's judgement;
- HIV infection;
- use of drugs potentially affecting cognitive function, according to the investigator's judgement;
- 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.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03834402
Start Date
May 1 2019
End Date
December 31 2023
Last Update
February 7 2024
Active Locations (1)
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1
Policlinico Agostino Gemelli
Rome, Italy, 00168