Autonomic Involvement in Patient With Cognitive Decline

Dementia, Mild Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292741
• Other study ID #: 4956
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Camillo Marra, MD
• Phone: 0630154333
• Email: camillo.marra[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2026
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia of Alzheimer Type
• Dementia, Mild

Intervention

Device:
• Sudoscan
recording of sudomotor function and pupillary reactivity

Locations

Country	Name	City	State
Italy	Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia	evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia	baseline through study completion, an average of 3 year
Secondary	correlation between the extent of autonomic involvement and the severity of cognitive decline	correlation between the extent of autonomic involvement (pupillary dilatation velocity) and the severity of cognitive decline (MMSE score)	baseline through study completion, an average of 3 year
Secondary	evaluation of the type of cognitive disorder, defined by the scores obtained in the MMSE between subjects with and without autonomic dysfunction.	evaluation of the type of cognitive disorder between subjects with and without autonomic dysfunction	baseline through study completion, an average of 3 year