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NCT06292741 Clinical Trial

Autonomic Involvement in Patient With Cognitive Decline

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

Clinical Trial Details — Status: Recruiting

Administrative data
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

Study information
Verified date April 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Camillo Marra, MD
Phone 0630154333
Email camillo.marra@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Sudoscan
recording of sudomotor function and pupillary reactivity

Locations
Country Name City State
Italy Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS Roma 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 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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