Autonomic Involvement in Patient With Cognitive Decline

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years - 85 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06292741
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Camillo Marra, MD
Principal Investigator Affiliation Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dementia, Mild, Dementia of Alzheimer Type
Arms & Interventions

Arms

Experimental: cognitive decline

comparison of autonomic parameters among subjects with different forms of cognitive decline

Interventions

Device: - Sudoscan

recording of sudomotor function and pupillary reactivity

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Rome 3169070, Lazio 3174976, Italy

Status

Recruiting

Address

Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS

Rome 3169070, Lazio 3174976, 00168

Site Contact

Camillo Marra, MD

[email protected]

0630154333

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