Autonomic Involvement in Patient With Cognitive Decline

Not Applicable

Recruiting

• Conditions: Dementia of Alzheimer Type; Dementia, Mild
• Interventions: Device: Sudoscan

• Registration Number: NCT06292741
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Status Verified: 2024-04
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-07
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cognitive decline	Sudoscan	comparison of autonomic parameters among subjects with different forms of cognitive decline

Primary Outcome Measures

Name	Time	Method
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia	baseline through study completion, an average of 3 year	evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia

Secondary Outcome Measures

Name	Time	Method
evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction.	baseline through study completion, an average of 3 year	evaluation of the type of cognitive disorder between subjects with and without autonomic dysfunction
correlation between the extent of autonomic involvement and the severity of cognitive decline	baseline through study completion, an average of 3 year	correlation between the extent of autonomic involvement (pupillary dilatation velocity) and the severity of cognitive decline (MMSE score)

Trial Locations

Locations (1)

Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS; 🇮🇹 Roma, Lazio, Italy