Validation of the I-UDS Neuropsychological Battery

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dementia Research Center

Pavia, 27100, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Uniform Data Set (UDS) neuropsychological battery

Other

Uniform Data Set (UDS) neuropsychological battery was administered to patients with Mild Cognitive Impairment (MCI) and patients with Alzheimer's Disease

Primary outcomes

I-UDS battery

Time frame: One time

Patients' scores in the tests of the I-UDS battery

Sponsors and collaborators

Lead sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Other

Collaborators

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Fondazione IRCCS Santa Lucia, Roma, Italy
Humanitas Research Hospital IRCCS, Rozzano-Milan
IRCCS AOU San Martino, Genova, Italy
IRCCS Associazione Oasi Maria SS. ONLUS, Troina, Italy
IRCCS Don Gnocchi, Milano, Italy
IRCCS Fondazione Policlinico Universitario Agostino Gemelli, Milano, Italy
IRCCS Fondazione Salvatore Maugeri, Pavia, Italy
IRCCS Istituto Auxologico Italiano, Milano, Italy
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy
IRCCS Istituto delle Scienze Neurologiche di Bologna
IRCCS Ospedale Maggiore Policlinico, Milano, Italy
IRCCS SDN, Napoli, Italy
IRCCS San Raffaele
Istituto Di Ricerche Farmacologiche Mario Negri

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Apr 7, 2023
Registry last updated: Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed