Autonomic Involvement in Patient 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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06292741

Enrollment

120

Registered

2024-03-05

Start date

2023-01-11

Completion date

2027-01-01

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Mild, Dementia of Alzheimer Type

Brief summary

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

Interventions

DEVICESudoscan

recording of sudomotor function and pupillary reactivity

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Contacts

CONTACTCamillo Marra, MD

camillo.marra@policlinicogemelli.it0630154333

PRINCIPAL_INVESTIGATORCamillo Marra, MD

Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026