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
1 other identifier
interventional
120
1 country
1
Brief Summary
Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2023
CompletedFirst Submitted
Initial submission to the registry
March 2, 2023
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
ExpectedSeptember 2, 2026
September 1, 2026
3.7 years
March 2, 2023
September 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
correlation between the extent of autonomic involvement and the severity of cognitive decline
baseline through study completion, an average of 3 year
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
Study Arms (1)
cognitive decline
EXPERIMENTALcomparison of autonomic parameters among subjects with different forms of cognitive decline
Interventions
recording of sudomotor function and pupillary reactivity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- diabetes mellitus
- eye problems
- severe cognitive decline
- heart disease
- peripheral neuropathy
- language barrier
- oncological disease
- medical pathologies associated with cognitive deficits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS
Rome, Lazio, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camillo Marra, MD
Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2023
First Posted
March 5, 2024
Study Start
January 11, 2023
Primary Completion
October 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
September 2, 2026
Record last verified: 2026-09