Adaptation of the Uniform Data Set for Telematic Administration

NCT05785910 | Active Not Recruiting

• 1 other identifier: 4074
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The present project is an evolution of the previous RIN 2019 study aimed at validating and standardizing the Uniform Data Set (UDS) for dementia, a battery of tests exploring various cognitive domains (memory, language, praxis, executive functions) and involving partial tablet-based computerization for data collection. In the present study, a UDS-based instrument that can be used in remote examiner-assisted telematic administration will be validated. This will be followed by standardization of the same on a sample of healthy subjects.

Conditions

Dementia, Mild; Dementia of Alzheimer Type

Outcome Measures

Primary Outcomes (1)

• concordance index

  Measure the concordance index in the administration of individual battery tests between in-person and computer-based administration

  from baseline through study completion, an average of 1 year and a half

Secondary Outcomes (1)

• regression lines

  from baseline through study completion, an average of 1 year and a half

Study Arms (1)

Normal subjects

EXPERIMENTAL

Diagnostic Test: IUDS

Interventions

IUDS DIAGNOSTIC_TEST

a battery of neuropsychological test

Normal subjects

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female and male subject between 50 and 90 years
• no negative score on the Anamnestic Questionnaire
• internist pathology in pharmacological compensation
• signing of informed consent

You may not qualify if:

• neurological pathologies
• decompensated metabolic pathology
• use of Benzodiazepine and psychoactive drugs

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Camillo Marra, MD

  Memory clinic, Fondazione Policlinico Gemelli, IRCCS, Università Cattolica del Sacro Cuore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 27, 2023
• Study Start: September 14, 2021
• Primary Completion: January 31, 2022
• Study Completion: December 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

IT (1)