Actively Recruiting

Phase Not Applicable
Age: 50Years - 85Years
All Genders
ID06292741

Evaluation of Autonomic Nervous System Involvement in Patients With Cognitive Impairment Using a Non-invasive Study of Dysautonomia

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-26

120

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating autonomic nervous system involvement in patients with various forms of cognitive decline, including mild cognitive impairment and dementia types such as Alzheimer's, Lewy's body dementia, and Parkinson's dementia. This interventional study uses a device to compare autonomic parameters among these patient groups to better understand the prevalence and characteristics of autonomic dysfunction related to cognitive decline. Participants will undergo assessments using the Sudoscan device, which records sudomotor function and pupillary reactivity, to measure autonomic function. The study compares these autonomic parameters in subjects with different types and severities of cognitive impairment. The primary study period spans an average of three years, during which participants are monitored for changes and correlations between autonomic dysfunction and cognitive decline severity. During the study, participants will be evaluated at baseline and follow-ups for autonomic dysfunction prevalence, cognitive disorder types assessed by MMSE scores, and the relationship between autonomic involvement and cognitive decline severity. Researchers will collect data on autonomic nervous system function and cognitive status to understand their connection better. The study includes continuous monitoring over approximately three years to assess these outcomes comprehensively.

CONDITIONS

Brief Title

Autonomic Involvement in Patient With Cognitive Decline

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and females between 50 and 85 years
  • Diagnosed with cognitive decline such as dementia, Lewy's body dementia, Parkinson's dementia, or Alzheimer's dementia
  • Mild cognitive decline including Lewy's body MCI, Parkinson MCI, and Alzheimer's MCI
  • Ability to assume the upright position
Not Eligible

You will not qualify if you...

  • Diabetes mellitus
  • Eye problems
  • Severe cognitive decline
  • Heart disease
  • Peripheral neuropathy
  • Language barrier
  • Oncological disease
  • Medical conditions associated with cognitive deficits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline through study completion, an average of 3 years

Participants undergo non-invasive device assessments to evaluate autonomic nervous system involvement related to cognitive decline.

Periodic visits for assessments over 3 years

Trial Site Locations

Total: 1 location

1

Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Lazio, Italy, 00168

Actively Recruiting

Loading map...

Research Team

C

Camillo Marra, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Similar Trials

Assess the Brain Levels of Fibrin in Alzheimer's Disease and...

Alzheimer Disease

Actively Recruiting

1 location

Effects of Buddy-Up Dyadic Physical Activity Program on Heal...

Cognitive Impairment, Mild

Actively Recruiting

1 location

Characterizing Variability in Hearing Aid Outcomes Among Old...

Hearing Loss, Sensorineural

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here