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Recruiting

NCT Number: NCT06292741

Autonomic Involvement in Patient With Cognitive Decline

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

Recruiting

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Key information

Conditions

Dementia, Mild Brain Diseases Central Nervous System Diseases Dementia Dementia of Alzheimer Type Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location status: Recruiting

Location contact

Camillo Marra, MD

CONTACT

[email protected]

0630154333

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sudoscan

Device

recording of sudomotor function and pupillary reactivity

Other names: automated pupillometry NPI-200

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Camillo Marra, MD

CONTACT

[email protected]

0630154333

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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