Adaptation of the Uniform Data Set for Telematic Administration

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05785910
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia, Mild; Dementia of Alzheimer Type	Diagnostic Test: IUDS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration
• Actual Study Start Date: Sep 14, 2021
• Actual Primary Completion Date: Jan 31, 2022
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal subjects	Diagnostic Test: IUDS; a battery of neuropsycological test

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• female and male subject between 50 and 90 years

• no negative score on the Questionario anamnestico tarature

• internist pathology in pharmacological compensation

• signing of informed consent

Exclusion Criteria:

• neurological pathologies

• decompensated methabolic pathology

• use of Benzodiazepine and psychoactive drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria	Rome	Lazio	Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

• Principal Investigator: Camillo Marra, MD, Memory clinic, Fondazione Policlinico Gemelli, IRCCS, Università Cattolica del Sacro Cuore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT05785910
• Other Study ID Numbers: 4074
• First Posted: Mar 27, 2023
• Last Update Posted: Mar 27, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Alzheimer Disease

Study Results

No Results Posted as of Mar 27, 2023