Clinical trial · Interventional
Adaptation of the Uniform Data Set for Telematic Administration
Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dementia, Mild | — | UNRESOLVED | — |
| Dementia of Alzheimer Type | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IUDS | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Normal subjects
- interventionNames
- Diagnostic Test: IUDS
Primary outcomes (1)
- measure
- concordance index
- timeFrame
- from baseline through study completion, an average of 1 year and a half
- description
- Measure the concordance index in the administration of individual battery tests between in-person and computer-based administration
Secondary outcomes (1)
- measure
- regression lines
- timeFrame
- from baseline through study completion, an average of 1 year and a half
- description
- Describe for each individual test the regression lines and correction factors for the interfering demographic variables (age schooling and sex)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available