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Adaptation of the Uniform Data Set for Telematic Administration

Primary Purpose

Dementia, Mild, Dementia of Alzheimer Type

Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IUDS
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia, Mild

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Normal subjects

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 2, 2023
Last Updated
March 23, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05785910
Brief Title
Adaptation of the Uniform Data Set for Telematic Administration
Official Title
Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Mild, Dementia of Alzheimer Type

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal subjects
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
IUDS
Intervention Description
a battery of neuropsycological test
Primary Outcome Measure Information:
Title
concordance index
Description
Measure the concordance index in the administration of individual battery tests between in-person and computer-based administration
Time Frame
from baseline through study completion, an average of 1 year and a half
Secondary Outcome Measure Information:
Title
regression lines
Description
Describe for each individual test the regression lines and correction factors for the interfering demographic variables (age schooling and sex)
Time Frame
from baseline through study completion, an average of 1 year and a half

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camillo Marra, MD
Organizational Affiliation
Memory clinic, Fondazione Policlinico Gemelli, IRCCS, Università Cattolica del Sacro Cuore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Adaptation of the Uniform Data Set for Telematic Administration

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