Validation of the I-UDS Neuropsychological Battery

NCT05803122 | Completed

• 1 other identifier: I-UDS2022
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• I-UDS battery

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

  One time

Study Arms (2)

Patients with Mild Cognitive Impairment (MCI)

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).

Other: Uniform Data Set (UDS) neuropsychological battery

Patients with Alzheimer's Disease (AD)

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).

Other: Uniform Data Set (UDS) neuropsychological battery

Interventions

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

Patients with Alzheimer's Disease (AD); Patients with Mild Cognitive Impairment (MCI)

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be administered the neuropsychological battery of the Italian Uniform Data Set (I-UDS) through a dedicated tablet application, and consisting of tests aimed at investigating the main cognitive domains, i.e. memory, attention, language, executive and visual-spatial skills. The duration of battery administration is approximately 45 minutes.

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Dementia Research Center

Pavia, 27100, Italy

Location

Related 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.

  PMID: 21514249 BACKGROUND

• 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.

  PMID: 21514250 BACKGROUND

• 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.

  PMID: 29240561 BACKGROUND

• 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.

  PMID: 19474567 BACKGROUND

• 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, Rotondo E, Tanzilli A, Pace A, Garramone F, Cavaliere C, Pardini M, Rizzetto C, Sorbi S, Perri R, Tiraboschi P, Canessa N, Cotelli M, Ferri R, Weintraub S, Marra C, Tagliavini F, Catricala E, Cappa SF. Italian adaptation of the Uniform Data Set Neuropsychological Test Battery (I-UDSNB 1.0): development and normative data. Alzheimers Res Ther. 2022 Aug 19;14(1):113. doi: 10.1186/s13195-022-01056-x.

  PMID: 35982477 RESULT

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Stefano Cappa, MD

  Dementia Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: July 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)