Validation of the I-UDS Neuropsychological Battery

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Other: Uniform Data Set (UDS) neuropsychological battery

• Registration Number: NCT05803122
• Lead Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation

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.

Study Timeline

• Study Start: 2022-07-15
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-03
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-03-26
• Last Update Submitted: 2023-03-26
• Study First Posted: 2023-04-07
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Alzheimer's Disease (AD)	Uniform Data Set (UDS) neuropsychological battery	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).
Patients with Mild Cognitive Impairment (MCI)	Uniform Data Set (UDS) neuropsychological battery	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).

Primary Outcome Measures

Name	Time	Method
I-UDS battery	One time	Patients' scores in the tests of the I-UDS battery

Trial Locations

Locations (1)

Dementia Research Center; 🇮🇹 Pavia, Italy