Autonomic Involvement in Patient With Cognitive Decline

August 25, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Evaluation of the Prevalence of Autonomic Nervous System Involvement in Patients With Cognitive Impairment by a Non-invasive Combined Study of Dysautonomia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Recruiting
        • Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive decline
comparison of autonomic parameters among subjects with different forms of cognitive decline
Device: Sudoscan
recording of sudomotor function and pupillary reactivity
Other Names:
  • automated pupillometry NPI-200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia
Time Frame: baseline through study completion, an average of 3 year
evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia
baseline through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between the extent of autonomic involvement and the severity of cognitive decline
Time Frame: 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)
baseline through study completion, an average of 3 year
evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction.
Time Frame: baseline through study completion, an average of 3 year
evaluation of the type of cognitive disorder between subjects with and without autonomic dysfunction
baseline through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Camillo Marra, MD, Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4956 (Egmont Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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