Autonomic Involvement in Patient With Cognitive Decline
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
Prospective interventional study with a device for comparing autonomic parameters among patients with different forms of cognitive decline
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
diabetes mellitus
eye problems
severe cognitive decline
heart disease
Trial design
Design model
Single group
Treatments tested in this trial
Sudoscan
Devicerecording of sudomotor function and pupillary reactivity
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: cognitive declineExperimental treatment 1 intervention
Trial outcomes
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
Time frame
baseline through study completion, an average of 3 yearSecondary outcomes
1
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)
Time frame
baseline through study completion, an average of 3 year2
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
Time frame
baseline through study completion, an average of 3 yearSponsors and contacts
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Source ClinicalTrials.gov