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Recruiting NCT06292741

Autonomic Involvement in Patient With Cognitive Decline

No phase Interventional Dementia, Mild Dementia of Alzheimer Type

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sudoscan.
Who it may be relevant to
Registry conditions: Dementia, Mild, Dementia of Alzheimer Type. Basic parameters: 50 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device Sudoscan
    recording of sudomotor function and pupillary reactivity

Primary outcome measures

  • evaluation of the prevalence in autonomic dysfunction in patients with MCI and dementia [Time frame: baseline through study completion, an average of 3 year]
Secondary outcome measures (2)
  • correlation between the extent of autonomic involvement and the severity of cognitive decline [Time frame: 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. [Time frame: baseline through study completion, an average of 3 year]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Italy · 1 center
  • Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS — Rome

Identifiers

NCT: NCT06292741 · 4956

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗