Clinical trial NCT05803122: Validation of the I-UDS Neuropsychological Battery
Official title: Validation of the I-UDS Neuropsychological Battery in Patients With Mild Cognitive Impairment and Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Keywords: Neuropsychological tests
UDS
Alzheimer's Disease
Mild Cognitive Impairment
Cognition
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
Collaborators: name: IRCCS Associazione Oasi Maria SS. ONLUS, Troina, Italy
name: IRCCS Istituto Auxologico Italiano, Milano, Italy
name: Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy
name: IRCCS San Raffaele
name: Fondazione IRCCS Santa Lucia, Roma, Italy
name: IRCCS Fondazione Policlinico Universitario Agostino Gemelli, Milano, Italy
name: IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
name: IRCCS Don Gnocchi, Milano, Italy
name: IRCCS Ospedale Maggiore Policlinico, Milano, Italy
name: IRCCS AOU San Martino, Genova, Italy
name: IRCCS SDN, Napoli, Italy
name: IRCCS Fondazione Salvatore Maugeri, Pavia, Italy
name: IRCCS Istituto delle Scienze Neurologiche di Bologna
name: Istituto Di Ricerche Farmacologiche Mario Negri
name: Humanitas Research Hospital IRCCS, Rozzano-Milan
First posted: 2023-04-07
Enrollment: 252
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be administered the neuropsychological battery of the Italian Uniform Data Set (I-UDS) through a dedicated tablet application, and consisting of tests aimed at investigating the main cognitive domains, i.e. memory, attention, language, executive and visual-spatial skills. The duration of battery administration is approximately 45 minutes.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: I-UDS battery
timeFrame: One time
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Dementia Research Center
Study officials:
affiliation: Dementia Research Center
name: Stefano Cappa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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