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Validation of the I-UDS Neuropsychological Battery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05803122
Enrollment
252
Registered
2023-04-07
Start date
2022-07-15
Completion date
2022-12-30
Last updated
2023-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Mild Cognitive Impairment

Keywords

Neuropsychological tests, UDS, Alzheimer's Disease, Mild Cognitive Impairment, Cognition

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.

Interventions

OTHERUniform Data Set (UDS) neuropsychological battery

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

Sponsors

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

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 89 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
I-UDS batteryOne timePatients' scores in the tests of the I-UDS battery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026