Could a quick sweat and pupil test spot early signs of dementia?

NCT ID NCT06292741

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This study looks at whether people with mild cognitive impairment or dementia also have problems with their autonomic nervous system, which controls automatic body functions like sweating and pupil response. Researchers will use two non-invasive devices, Sudoscan and automated pupillometry, to measure these functions in 120 adults aged 50 to 85 with various forms of cognitive decline. The goal is to see how common autonomic dysfunction is and whether its severity matches the level of memory loss. This could lead to simpler ways to help diagnose or monitor cognitive disorders.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sudoscan device and automated pupillometry NPI-200
What this could lead to
If autonomic dysfunction is common in early cognitive decline, doctors might use simple, non-invasive tests to help detect or monitor dementia and mild cognitive impairment.
What could go wrong
This is an observational-style study with no treatment, so it cannot prove cause and effect. Results may not apply to all types of dementia, and the tests might not reliably distinguish between conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Clinica della memria- Fondazione Policlinico Agostino Gemelli IRCCS

    RECRUITING

    Rome, Lazio, 00168, Italy

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