Adaptation of the Uniform Data Set for Telematic Administration

Dementia, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05785910
• Other study ID #: 4074
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: September 2024
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia of Alzheimer Type
• Dementia, Mild

Intervention

Diagnostic Test:
• IUDS
a battery of neuropsychological test

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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