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Optimization and Harmonization of Advanced MRI Sequences | Clinical Trials | Clareo Health

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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

NCT06217237•IRCCS Centro Neurolesi Bonino Pulejo

View on ClinicalTrials.gov

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

Age

50 - 80 years

Sex

ALL

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;
+1 more criteria

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.

Locations (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, Italy

Key Dates

Start Date

January 10, 2019

Primary Completion Date

December 22, 2020

Completion Date

January 10, 2021

Last Updated

January 22, 2024

Enrollment

400

ACTUAL participants

Conditions

Dementia FrontalDementia AlzheimersLewy Body Variant of Alzheimer DiseaseNeuro-Degenerative Disease

Interventions

AD FDT DBL GROUP

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optimization and Harmonization of Advanced MRI Sequences

Inclusion Criteria

Exclusion Criteria

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