Autonomic Involvement in Patient With Cognitive Decline

NCT ID: NCT06292741

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia, Mild Dementia of Alzheimer Type

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cognitive decline

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

Group Type EXPERIMENTAL

Sudoscan

Intervention Type DEVICE

recording of sudomotor function and pupillary reactivity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sudoscan

recording of sudomotor function and pupillary reactivity

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

automated pupillometry NPI-200

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Camillo Marra, MD

Role: PRINCIPAL_INVESTIGATOR

Memory clinic- Policlinico Agostino Gemelli, IRCCS, Università Cattolica del Sacro Cuore I

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS

Rome, Lazio, Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Camillo Marra, MD

Role: CONTACT

0630154333

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Camillo Marra, MD

Role: primary

0630154333

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4956

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MOVE for Your MIND
NCT03384602 COMPLETED NA