Comparing autonomic function in patients with cognitive decline
Evaluation of the Prevalence of Autonomic Nervous System Involvement in Patients With Cognitive Impairment by a Non-invasive Combined Study of Dysautonomia
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06292741
This study is testing how well a device can measure the automatic functions of the body in people aged 50 to 85 who have mild cognitive decline, like mild dementia or Alzheimer's, to better understand their condition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06292741 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate autonomic parameters in patients experiencing various forms of cognitive decline, including mild dementia and Alzheimer's disease. Participants will use a device called Sudoscan to assess their autonomic function. The study will include individuals aged 50 to 85 who can maintain an upright position and have mild cognitive impairment. By comparing these parameters across different types of cognitive decline, the study seeks to enhance understanding of autonomic involvement in dementia.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 50 to 85 with mild cognitive decline due to various forms of dementia.
Not a fit: Patients with severe cognitive decline, diabetes, heart disease, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and treatment strategies for patients with cognitive decline.
How similar studies have performed: While this approach is relatively novel, similar studies exploring autonomic function in dementia have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome, Lazio
- Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS — Rome, Lazio, Italy (RECRUITING)
Study contacts
- Principal investigator: Camillo Marra, MD — Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I
- Study coordinator: Camillo Marra, MD
- Email: camillo.marra@policlinicogemelli.it
- Phone: 0630154333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dementia, Mild, Dementia of Alzheimer Type