Optimization and Harmonization of Advanced MRI Sequences

NCT06217237 | Completed

• 1 other identifier: RETEimaging_IRCCS_001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Quantitative Susceptibility Mapping (QSM), Diffusion Weighted Imaging (DWI) - Diffusion Tensor Imaging (DTI), Fluid Attenuated Inversion Recovery (FLAIR)

  The main endpoint is the characterization of white matter alterations in different forms of dementing diseases through the combined study of MRI sequences. Specifically, we correlate Voxel Based Morphometry indices, DTI quantifcation and lesions volume with MMSE and MOCA scores.

  during MRI procedure

Secondary Outcomes (1)

• FLAIR, QSM, DWI (DTI) for white matter study

  during MRI procedureRMN date examination

Study Arms (2)

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).

Diagnostic Test: AD FDT DBL GROUP

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).

Interventions

AD FDT DBL GROUP 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).

AD FDT DBL GROUP

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients and controls recruited based on the inclusion criteria carry out clinical and neuropsychological tests

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

Location

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Variant of Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: January 22, 2024
• Study Start: January 10, 2019
• Primary Completion: December 22, 2020
• Study Completion: January 10, 2021
• Last Updated: January 22, 2024

Record last verified: 2023-10

Locations

IT (1)