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Active, Not Recruiting

NCT Number: NCT05785910

Adaptation of the Uniform Data Set for Telematic Administration

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dementia, Mild Brain Diseases Central Nervous System Diseases Dementia Dementia of Alzheimer Type Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria

Rome, Lazio, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

IUDS

Diagnostic Test

a battery of neuropsychological test

Primary outcomes

  1. concordance index

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

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

Secondary outcomes

  1. regression lines

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

    Describe for each individual test the regression lines and correction factors for the interfering demographic variables (age schooling and sex)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Mar 27, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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