Validation of the I-UDS Neuropsychological Battery

Study Overview
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Brief Summary
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The current project entails the validation of the Italian version of the Uniform Data Set (I-UDS) neuropsychological in patients with neurodegenerative diseases, specifically in patients with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). Specifically, the final aim is to explore the ability of the battery to differentiate the cognitive profiles of the two groups of patients.

Detailed Description
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The harmonization of procedures for neuropsychological assessment in dementia disorders is essential for the development of shared activities and projects within the IRCCS Network of Neuroscience and Neurorehabilitation (RIN). To this end, a previous project of the network was dedicated to the translation and adaptation of the Uniform Data Set (UDS) neuropsychological battery, following the similar initiative of the National Alzheimer's Coordinating Center (NACC) USA . This project led to the creation of the I-UDS, which can be administered via a tablet application and consists of tests aimed at investigating different cognitive domains, namely memory, attention, language, executive and visuospatial skills. Normative data were obtained from a sample of 433 healthy participants. In order to be able to use the I-UDS battery in clinical and research settings, it is essential to validate its application in patients with neurodegenerative diseases. In particular, in line with the NACC initiative, the battery aims to trace and highlight the continuum between Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD). The present multicenter study therefore aims to test the I-UDS battery in patients with clinical diagnoses of MCI and AD, in order to explore its ability to differentiate the cognitive profiles of the two groups of patients.

Official Title
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Validation of the I-UDS Neuropsychological Battery in Patients With Mild Cognitive Impairment and Alzheimer's Disease

Conditions
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Mild Cognitive Impairment, Alzheimer Disease

Intervention / Treatment
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* Other: Uniform Data Set (UDS) neuropsychological battery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of MCI or AD based on diagnostic research criteria after a protocol of clinical, neuropsychological, structural brain imaging evaluation and biomarkers positivity assessment (amyloid-PET and/or CSF); performance in the Mini-Mental State Examination (MMSE) above/equal 20 (score corrected for age and education); Exclusion Criteria: prior/current cerebrovascular disorders; a history of traumatic brain injury, brain tumors, stroke; concomitant medical, sensory and/or motor deficits possibly affecting performance; a history of alcohol and/or drug abuse; use of medications influencing cognitive functions.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Mild Cognitive Impairment (MCI)<br>Patients with diagnosis of MCI based on diagnostic research criteria , after a protocol of clinical, neuropsychological, structural brain imaging evaluation and biomarkers positivity assessment (amyloid-Positron Emission Tomography (PET) and/or Cerebral Spinal Fluid -CSF). | Other: Uniform Data Set (UDS) neuropsychological battery<br>* Uniform Data Set (UDS) neuropsychological battery was administered to patients with Mild Cognitive Impairment (MCI) and patients with Alzheimer's Disease<br>|
| Patients with Alzheimer's Disease (AD)<br>Patients with diagnosis of AD based on diagnostic research criteria , after a protocol of clinical, neuropsychological, structural brain imaging evaluation and biomarkers positivity assessment (amyloid-PET and/or CSF). | Other: Uniform Data Set (UDS) neuropsychological battery<br>* Uniform Data Set (UDS) neuropsychological battery was administered to patients with Mild Cognitive Impairment (MCI) and patients with Alzheimer's Disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| I-UDS battery | Patients' scores in the tests of the I-UDS battery | One time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuropsychological tests, UDS, Alzheimer's Disease, Mild Cognitive Impairment, Cognition