Optimization and Harmonization of Advanced MRI Sequences

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Completed

Conditions: Neuro-Degenerative Disease; Dementia Frontal; Dementia Alzheimers; Lewy Body Variant of Alzheimer Disease

Treatments: Diagnostic Test: AD FDT DBL GROUP

Study type: Observational

Funder types: Other

Identifiers

NCT06217237

RETEimaging_IRCCS_001

Details and patient eligibility

About

Development of a shared multimodal MRI protocol for the definition and quantification of imaging biomarkers in AD, DLB, FDT dementias, especially white matter alterations.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

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.

Trial design

400 participants in 2 patient groups

AD FDT DBL GROUP

Description:

All participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM).

Treatment:

Diagnostic Test: AD FDT DBL GROUP

CONTROL GROUP

Description:

All participants will undergo an MRI session. The MRI protocol will include the clinical diagnostic protocol defined within the Network and research sequences as specified above (T1 3D, DTI, FLAIR 3D, QSM).