Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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