Adaptation of the Uniform Data Set for Telematic Administ... | NCT05785910

Studies
Adaptation of the Uniform Data Set for Telematic Administration

NCT05785910

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Active, not recruiting

Last Update Posted

Sep 19, 2025Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Dementia, Mild
Dementia of Alzheimer Type

Interventions

IUDS

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2021Actual

Primary Completion Date

Jan 31, 2022Actual

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 2, 2023

First Submission Date that Met QC Criteria

Mar 23, 2023

First Posted Date

Mar 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2025

Last Update Posted Date

Sep 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Normal subjects	Experimental		Diagnostic Test: IUDS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IUDS	Diagnostic Test	a battery of neuropsychological test	Normal subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
regression lines	Describe for each individual test the regression lines and correction factors for the interfering demographic variables (age schooling and sex)	from baseline through study completion, an average of 1 year and a half

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Camillo Marra, MD	Memory clinic, Fondazione Policlinico Gemelli, IRCCS, Università Cattolica del Sacro Cuore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria		Rome	Lazio	00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided