Status:
COMPLETED
Optimization and Harmonization of Advanced MRI Sequences
Lead Sponsor:
IRCCS Centro Neurolesi Bonino Pulejo
Conditions:
Dementia Frontal
Dementia Alzheimers
Eligibility:
All Genders
50-80 years
Brief Summary
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
Detailed Description
Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.
Eligibility Criteria
Inclusion
- for patients
- accident cases
- time of onset of NOT MORE THAN 24 months
- Clinical Dementia Rating Scale (CDR) \<=2;
- MoCA\<=17
- for controls absence of complaints of cognitive disorders and/or neurological/neuropsychological visits for the evaluation of such disorders;
- CDR = 0;
- MoCA\>=27. for all Age \>= 50 and \<= 80;
- Hachinski Ischemic Scale - 7 items \< 2;
- visual and/or auditory acuity sufficient to carry out the neuropsychological assessment;
- if on neuropsychopharmacological therapy, stability for 4 weeks before the start of the study.
Exclusion
- for all
- any uncontrolled medical condition or neurological/neurodegenerative disease that, in the opinion of the recruiting physician, could contribute to the individual's cognitive impairment \[e.g., kidney disease, liver disease, brain tumor, alcohol or drug abuse, abnormal thyroid function, hydrocephalus normotensive, vascular dementia, neurocognitive disorder due to head trauma (according to the diagnostic criteria of the DSM V)\];
- transient ischemic attack or stroke during the 12 months preceding screening; history of unstable angina, myocardial infarction, heart failure (New York Heart Association Class III or IV), or clinically significant heart rhythm disturbances documented within one year of screening;
- history of malignant tumor disease, except: cancer in remission for more than 5 years since screening; prostate cancer in situ;
- history of surgically treated squamous cell carcinoma or basal cell carcinoma;
- impaired liver function or liver failure;
- history or evidence of autoimmune disease considered clinically significant by the doctor or requiring the chronic use of corticosteroids or other immunosuppressive drugs;
- clinically significant systemic illness or infection within 30 days of screening; comorbidity for primary psychiatric or neurological disorders;
- absence of an informant (partner, relative, adult child or friend) who knows the subject well enough to be able to provide reliable information on his cognitive and functional abilities.
- contraindication to carrying out the MRI exam.
Key Trial Info
Start Date :
January 10 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 10 2021
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06217237
Start Date
January 10 2019
End Date
January 10 2021
Last Update
January 22 2024
Active Locations (1)
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1
IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, Italy, 98124