Adaptation of the Uniform Data Set for Telematic Administration

Not Applicable

Active, not recruiting

• Conditions: Dementia, Mild; Dementia of Alzheimer Type
• Interventions: Diagnostic Test: IUDS

• Registration Number: NCT05785910
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-14
• Primary Completion: 2022-01-31
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-03-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal subjects	IUDS	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria; 🇮🇹 Rome, Lazio, Italy