Optimization and Harmonization of Advanced MRI Sequences

Phase II Neuroimaging Network: Optimization and Harmonization of Advanced MRI Sequences and Their Application in the Study of Dementia and Intellectual Disability in Pediatric Age

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

Study Overview

• Status: Completed
• Conditions: Dementia Alzheimers; Neuro-Degenerative Disease; Lewy Body Variant of Alzheimer Disease; Dementia Frontal
• Intervention / Treatment: Diagnostic test: AD FDT DBL GROUP

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy, 98124
    • IRCCS Centro Neurolesi "Bonino-Pulejo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLAIR, QSM, DWI (DTI) for white matter study	Quantitative analysis of FLAIR, QSM, DWI (DTI) for white matter evaluation ES2. Characterization of white matter alterations which will also take place through the quantification of: microstructure and macrostructure values of the white matter through diffusion techniques (including DTI); white matter lesions through post-processing algorithms (14) applied to the FLAIR sequence;; magnetic susceptibility in the white matter and in particular in myelin (15), through the QSM technique; ES3. Definition of an automatic single-case multimodal algorithm (MUQUBIA) for the quantification and classification of subjects with alterations of the white matter (as emerged from MRI data) useful for doctors in the Network. ES4. Evaluation of variables of interest emerging from MRI analyzes in relation to clinical and neuropsychological variables	during MRI procedureRMN date examination

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): December 22, 2020
• Study Completion (Actual): January 10, 2021

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Tauopathies; Dementia; Alzheimer Disease; Neurodegenerative Diseases; Lewy Body Disease
• Other Study ID Numbers: RETEimaging_IRCCS_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No