Dementia With Lewy BodiesNCT06467461
5-HT RBD REM Sleep Behavior Disorder
A study testing Skin biopsy, Speech testing and Ultra high field 7T MRI in people with Dementia With Lewy Bodies and Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial summary
This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies, Parkinson Disease, REM Sleep Behavior Disorder
- What is being tested?
- Skin biopsy, Speech testing and Ultra high field 7T MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2024to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Serotonergic REM sleep behavior (5-HT RBD) participants
- 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
- 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
Who cannot join
- Serotonergic REM sleep behavior (5-HT RBD) participants
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy.
The investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.
- Being tested
- Skin biopsy, Speech testing, Ultra high field 7T MRI
- Medical subject headings
- Lewy Body Disease, Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyDiagnostic test
Skin biopsy to detect systemic alpha-synuclein pathology in 5-HT RBD
Speech testingDiagnostic test
Speech Testing to quantify evolving signs of 5-HT RBD
Ultra high field 7T MRIDiagnostic test
7T MRI to examine 5-HT RBD for evidence of brainstem neurodegeneration
| Study group | Role | What they receive |
|---|---|---|
| Research participants | Other | Adults under the age of 75; who do not meet criteria for Parkinson's disease, dementia with Lewy bodies, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD; and have a history of or currently use the SSRIs of interest. Receives: Diagnostic Test: Skin biopsy; Diagnostic Test: Speech testing; Diagnostic Test: Ultra high field 7T MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphorylated alpha synuclein deposits on skin biopsy
Incidence (positive or negative) of phosphorylated alpha synuclein deposits. Indicating direct histopathological confirmation of underlying alpha-synuclein degeneration in 5-HT RBD in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD).
Measured: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Neuromelanin signal intensity in the Subcoeruleus/Coeruleus Complex
Examination of the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures.
Measured: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Monopitch as measured by fundamental frequency variability.
Participants' voice and speech quality will be examined for synucleinopathy syndrome. The focus on speech function is designed to detect subtle brainstem deficits prior to more overt manifestations of cortical dementia.
Measured: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Secondary outcomes (2)
Subject-specific masks of all REM sleep-related pontine nuclei of interest, volume of Subcoeruleus/Coeruleus Complex.
Subject-specific masks of all REM sleep-related pontine nuclei of interest, volume of Subcoeruleus/Coeruleus Complex.
Measured: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Speed of articulatory change as measured by F2 Transitions
Speed of articulatory change as measured by F2 Transitions, which are shown to be reduced in people with dysarthria
Measured: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start8 Feb 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Howell, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467461
- Sponsor's protocol ID
- NEUR-2023-32484
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder
- ClinicalTrials.gov ID
- NCT06467461
- Acronym / sponsor ID
- NEUR-2023-32484
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy.
The investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research participants | Other | Diagnostic Test: Skin biopsy, Diagnostic Test: Speech testing, Diagnostic Test: Ultra high field 7T MRIAdults under the age of 75; who do not meet criteria for Parkinson's disease, dementia with Lewy bodies, Alzheimer's disease, other diagnosed neurodegenerative disorder, or other known cause of RBD; and have a history of or currently use the SSRIs of interest. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Serotonergic REM sleep behavior (5-HT RBD) participants
- 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
- 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.
Key exclusion criteria (13 listed)
- Serotonergic REM sleep behavior (5-HT RBD) participants
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsySkin biopsy to detect systemic alpha-synuclein pathology in 5-HT RBD | Diagnostic test | Research participants |
| Speech testingSpeech Testing to quantify evolving signs of 5-HT RBD | Diagnostic test | Research participants |
| Ultra high field 7T MRI7T MRI to examine 5-HT RBD for evidence of brainstem neurodegeneration | Diagnostic test | Research participants |
Primary outcome
Phosphorylated alpha synuclein deposits on skin biopsy
Time frame: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Incidence (positive or negative) of phosphorylated alpha synuclein deposits. Indicating direct histopathological confirmation of underlying alpha-synuclein degeneration in 5-HT RBD in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD).
Neuromelanin signal intensity in the Subcoeruleus/Coeruleus Complex
Time frame: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Examination of the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures.
Monopitch as measured by fundamental frequency variability.
Time frame: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Participants' voice and speech quality will be examined for synucleinopathy syndrome. The focus on speech function is designed to detect subtle brainstem deficits prior to more overt manifestations of cortical dementia.
2 secondary outcomes
Subject-specific masks of all REM sleep-related pontine nuclei of interest, volume of Subcoeruleus/Coeruleus Complex.
Time frame: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Speed of articulatory change as measured by F2 Transitions
Time frame: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Howell, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy, Speech testing and Ultra high field 7T MRI in people with Dementia With Lewy Bodies and Parkinson Disease, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phosphorylated alpha synuclein deposits on skin biopsy (time frame: time point 1 (baseline) and time point 2 (24 months, +/- 3 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.