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Skin, speech, and brain scans may unmask hidden neurodegeneration

NCT ID NCT06467461

Diagnosis Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This study investigates whether a combination of skin biopsies, speech analysis, and ultra-high field 7T MRI can detect early signs of Parkinson's disease and dementia with Lewy bodies. It focuses on people with a specific type of REM sleep behavior disorder triggered by serotonergic antidepressants, which may be an early warning sign. The research will compare these individuals to matched controls over 30 months to see if these tests can identify underlying neurodegeneration.

What this could mean

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

Active substance
Skin biopsy, speech testing, and ultra-high field 7T MRI as diagnostic tools
What this could lead to
If successful, this could lead to earlier detection of Parkinson's disease and Lewy body dementia, potentially enabling earlier intervention and better management.
What could go wrong
This is an early-stage diagnostic study with a small sample size. The tests may not reliably distinguish those who will develop neurodegeneration from those who won't, and results may not generalize to broader populations.

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

66 people

The number who actually took part.

Started

Feb 2024

Expected to finish

Sep 2028

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Serotonergic REM sleep behavior (5-HT RBD) participants Inclusion Criteria: * Diagnosis of polysomnogram-confirmed RBD with history of dream enactment or clear dream enactment visualized on video from polysomnogram. * History of dream enactment began shortly after (less than 2 months) starting a serotonergic antidepressant medication. Control Participants Inclusion Criteria: * Age (±3 years) and sex matched to participants with 5-HT RBD * On serotonergic medication for at least 6 months without history of dream enactment. The following serotonergic medications will be included: Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, and Sertraline Exclusion Criteria: Serotonergic REM sleep behavior (5-HT RBD) participants Exclusion Criteria: * Younger than 18 * Older than 75 * Meet criteria for Parkinson's disease, dementia with Lewy bodies, Multiple System Atrophy, Pure Autonomic Failure, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD (e.g. narcolepsy) * Untreated obstructive sleep apnea, obesity hypoventilation, central sleep apnea or other sleep disordered breathing * History of dysarthria, aphasia or other condition which could interfere with speech assessment * Reduced capacity to consent * MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, etc.). * History of allergic response to xylocaine or other local anesthesia * Pregnant women will be excluded due to unknown risk of MRI on developing fetus Control Participants Exclusion Criteria: same exclusion criteria as 5-HT RBD group, plus the following: * History of dream enactment that may suggest RBD * Increased REM motor tone (REM atonia index \> 0.10) on PSG suggestive of RBD

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Conditions

The condition(s) this trial relates to.

Lewy body dementia Lewy Body Disease Parkinson disease REM sleep behavior disorder

As listed by the trial registrant

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

Dementia with lewy bodies Parkinson disease Rem sleep behavior disorder

Contacts and locations

Locations

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.