Clinical trial NCT06217237: Optimization and Harmonization of Advanced MRI Sequences
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia Frontal
Dementia Alzheimers
Lewy Body Variant of Alzheimer Disease
Neuro-Degenerative Disease
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients and controls recruited based on the inclusion criteria carry out clinical and neuropsychological tests

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 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.

Primary outcomes:
measure: Quantitative Susceptibility Mapping (QSM), Diffusion Weighted Imaging (DWI) - Diffusion Tensor Imaging (DTI), Fluid Attenuated Inversion Recovery (FLAIR)
timeFrame: during MRI procedure
Secondary outcomes:
measure: FLAIR, QSM, DWI (DTI) for white matter study
timeFrame: during MRI procedureRMN date examination
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi "Bonino-Pulejo"
Study officials:
References: