Validation of the I-UDS Neuropsychological Battery

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803122
• Other study ID #: I-UDS2022
• Status: Completed
• Start date: July 15, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: IRCCS National Neurological Institute "C. Mondino" Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Uniform 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

Locations

Country	Name	City	State
Italy	Dementia Research Center	Pavia

Sponsors (16)

Lead Sponsor

Collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy, Fondazione IRCCS Santa Lucia, Roma, Italy, 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 Humanitas Mirasole, Rozzano -Milano, Italy, IRCCS Istituto Auxologico Italiano, Milano, Italy, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy, IRCCS Istituto Scienze Neurologiche Bologna, Italy, IRCCS Ospedale Maggiore Policlinico, Milano, Italy, IRCCS Ospedale San Raffaele, Milano, Italy, IRCCS SDN, Napoli, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21. — View Citation

Conca F, Esposito V, Rundo F, Quaranta D, Muscio C, Manenti R, Caruso G, Lucca U, Galbussera AA, Di Tella S, Baglio F, L'Abbate F, Canu E, Catania V, Filippi M, Mattavelli G, Poletti B, Silani V, Lodi R, De Matteis M, Stanzani Maserati M, Arighi A, Rotond — View Citation

McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21. — View Citation

Weintraub S, Besser L, Dodge HH, Teylan M, Ferris S, Goldstein FC, Giordani B, Kramer J, Loewenstein D, Marson D, Mungas D, Salmon D, Welsh-Bohmer K, Zhou XH, Shirk SD, Atri A, Kukull WA, Phelps C, Morris JC. Version 3 of the Alzheimer Disease Centers' Neuropsychological Test Battery in the Uniform Data Set (UDS). Alzheimer Dis Assoc Disord. 2018 Jan-Mar;32(1):10-17. doi: 10.1097/WAD.0000000000000223. — View Citation

Weintraub S, Salmon D, Mercaldo N, Ferris S, Graff-Radford NR, Chui H, Cummings J, DeCarli C, Foster NL, Galasko D, Peskind E, Dietrich W, Beekly DL, Kukull WA, Morris JC. The Alzheimer's Disease Centers' Uniform Data Set (UDS): the neuropsychologic test battery. Alzheimer Dis Assoc Disord. 2009 Apr-Jun;23(2):91-101. doi: 10.1097/WAD.0b013e318191c7dd. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	I-UDS battery	Patients' scores in the tests of the I-UDS battery	One time