Optimization and Harmonization of Advanced MRI Sequences

NCT ID: NCT06217237

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2021-01-10

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

AD FDT DBL GROUP

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).

AD FDT DBL GROUP

Intervention Type: DIAGNOSTIC_TEST

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).

CONTROL GROUP

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).

No interventions assigned to this group

Interventions

AD FDT DBL GROUP

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, , Italy

Countries

Italy

Other Identifiers

RETEimaging_IRCCS_001

Identifier Type: -

Identifier Source: org_study_id