Dementia of Alzheimer Type Clinical Trial
Official title:
Evaluation of the Prevalence of Autonomic Nervous System Involvement in Patients With Cognitive Impairment by a Non-invasive Combined Study of Dysautonomia
NCT number | NCT06292741 |
Other study ID # | 4956 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 11, 2023 |
Est. completion date | January 2026 |
Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline
Status | Recruiting |
Enrollment | 120 |
Est. completion date | January 2026 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: - male and females between 50 and 85 years - cognitive decline (dementia, lewy's body dementia, Parkinson dementia, Alzheimer dementia) - mild cognitive decline ( lewy's body MCI, Parkinson MCI and Alzheimer MCI) - Ability to assume the upright position Exclusion Criteria: - diabetes mellitus - eye problems - severe cognitive decline - heart disease - peripheral neuropathy - language barrier - oncological disease - medical pathologies associated with cognitive deficits |
Country | Name | City | State |
---|---|---|---|
Italy | Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS | Roma | Lazio |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia | evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia | baseline through study completion, an average of 3 year | |
Secondary | correlation between the extent of autonomic involvement and the severity of cognitive decline | correlation between the extent of autonomic involvement (pupillary dilatation velocity) and the severity of cognitive decline (MMSE score) | baseline through study completion, an average of 3 year | |
Secondary | evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction. | evaluation of the type of cognitive disorder between subjects with and without autonomic dysfunction | baseline through study completion, an average of 3 year |
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