Adaptation of the Uniform Data Set for Telematic Administration

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05785910

Enrollment

Registered

2023-03-27

Start date

2021-09-14

Completion date

2025-09-01

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Mild, Dementia of Alzheimer Type

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.

Interventions

DIAGNOSTIC_TESTIUDS

a battery of neuropsychological test

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
concordance index	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

Measure	Time frame	Description
regression lines	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)

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORCamillo Marra, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026