Validation of the I-UDS Neuropsychological Battery

IRCCS National Neurological Institute "C. Mondino" Foundation

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Treatments: Other: Uniform Data Set (UDS) neuropsychological battery

Study type: Observational

Funder types: Other

Identifiers

NCT05803122

I-UDS2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

252 participants in 2 patient groups

Patients with Mild Cognitive Impairment (MCI)

Description:

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).

Treatment:

Other: Uniform Data Set (UDS) neuropsychological battery

Patients with Alzheimer's Disease (AD)

Description:

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).

Treatment:

Other: Uniform Data Set (UDS) neuropsychological battery