Dementia of Alzheimer Type Clinical Trial
Official title:
Harmonization and Updating of Cognitive and Behavioral Assessment Procedures in Neurology: Adaptation of the Uniform Data Set for Telematic Administration
Verified date | April 2024 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Clinica della memoria | Rome | Lazio |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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 |
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