Idiopathic Parkinson's Disease and Lewy Body DiseasePI-PEGNCT06439355
Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
A study testing Fasting blood test, Subject interview and Motor assessment in people with Idiopathic Parkinson's Disease and Lewy Body Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants: healthy volunteers patients with early Parkinson's disease patients with incipient Lewy body disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Parkinson's Disease and Lewy Body Disease
- What is being tested?
- Fasting blood test, Subject interview and Motor assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2024to May 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers:
- Person who has given written consent
- Adult
- Enrolled in the national register of healthy volunteers
- Fasting > 2 hours before PEG measurement
- Body Mass Index (BMI) < 30 kg/m².
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- No cognitive complaints and normal neurological assessment
- Patients with idiopathic Parkinson's disease:
- Person who has given written consent
- Adult
- Fasting > 2 hours before PEG measurement
- Body Mass Index (BMI) < 30 kg/m².
- Diagnostic criteria for established or probable IPD
- Patients with Lewy body disease:
- Person who has given written consent
- Adult
- Fasting > 2 hours prior to PEG measurement
- Body Mass Index (BMI) < 30 kg/m².
- Diagnostic criteria for probable or possible LBD
Who cannot join
- Non-affiliated to national health insurance
- Person under legal protection (curatorship, guardianship)
- Person subject to a court order
- Pregnant, parturient or breast-feeding women
- Major unable to give consent
- MMSE score < 15 and/or MoCA < 10
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- Known infection with COVID-19 in the 6 months prior to inclusion
- Active smoker (> 4 cigarettes per day on a regular basis)
- Subject with pacemaker (contraindication for bioelectrical impedancemetry)
- Diabetic (type 1 or type 2)
- Taking medication (in progress at the time of the study) that interferes with gustation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon
Vincent SCHNEIDER, 03.80.29.30.89, vincent.schneider@chu-dijon.fr
About this study
The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants:
- healthy volunteers
- patients with early Parkinson's disease
- patients with incipient Lewy body disease.
Read more
To this end, the results obtained from taste evoked potentials in each of the 3 groups of participants will be compared with each other and with different nutritional, motor and cognitive data.
This study could reveal a difference in cortical processing of gustatory sensory information between patients who have had idiopathic Parkinson's disease progressing for 3 years or less, and patients who have had Lewy body disease progressing for 3 years or less. Indeed, a modification of taste evoked potentials (in terms of latencies) proportional to the degree of cerebral degeneration could be observed.
- Being tested
- Fasting blood test, Subject interview, Motor assessment, Neurocognitive assessment, Nutritional assessment
- Medical subject headings
- Parkinson Disease, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting blood testBiological
metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays
Subject interviewOther
socio-demographic data, medical and family history, treatment taken
Motor assessmentOther
MDS-UPDRS scale PART III
Neurocognitive assessmentOther
MoCA and MMSE scales
Nutritional assessmentOther
anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass)
Taste testsOther
Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Active comparator | Not described Receives: Biological: Fasting blood test; Other: Subject interview; Other: Motor assessment; Other: Neurocognitive assessment; Other: Nutritional assessment; Other: Taste tests |
| Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years | Experimental | Not described Receives: Biological: Fasting blood test; Other: Subject interview; Other: Motor assessment; Other: Neurocognitive assessment; Other: Nutritional assessment; Other: Taste tests |
| Patients with Lewy body disease (LBD) progressing ≤ 3 years | Experimental | Not described Receives: Biological: Fasting blood test; Other: Subject interview; Other: Motor assessment; Other: Neurocognitive assessment; Other: Nutritional assessment; Other: Taste tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average latency of taste-evoked potentials
Measured: After a 2-hour fasting period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start27 May 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's Disease and Lewy Body DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439355
- Sponsor's protocol ID
- SCHNEIDER J'InvEST-I 2023
- Acronym
- PI-PEG
- Status last verified
- Oct 2026
- First submitted
- 28 May 2024
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis
- ClinicalTrials.gov ID
- NCT06439355
- Acronym / sponsor ID
- PI-PEG / SCHNEIDER J'InvEST-I 2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 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.
The aim of the PI-PEG study is to explore the taste functions of the following 3 groups of participants:
- healthy volunteers
- patients with early Parkinson's disease
- patients with incipient Lewy body disease.
To this end, the results obtained from taste evoked potentials in each of the 3 groups of participants will be compared with each other and with different nutritional, motor and cognitive data.
This study could reveal a difference in cortical processing of gustatory sensory information between patients who have had idiopathic Parkinson's disease progressing for 3 years or less, and patients who have had Lewy body disease progressing for 3 years or less. Indeed, a modification of taste evoked potentials (in terms of latencies) proportional to the degree of cerebral degeneration could be observed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Active comparator | Biological: Fasting blood test, Other: Subject interview, Other: Motor assessment, Other: Neurocognitive assessment, Other: Nutritional assessment, Other: Taste tests |
| Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years | Experimental | Biological: Fasting blood test, Other: Subject interview, Other: Motor assessment, Other: Neurocognitive assessment, Other: Nutritional assessment, Other: Taste tests |
| Patients with Lewy body disease (LBD) progressing ≤ 3 years | Experimental | Biological: Fasting blood test, Other: Subject interview, Other: Motor assessment, Other: Neurocognitive assessment, Other: Nutritional assessment, Other: Taste tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Person who has given written consent
- Adult
- Enrolled in the national register of healthy volunteers
- Fasting > 2 hours before PEG measurement
- Body Mass Index (BMI) < 30 kg/m².
Key exclusion criteria (11 listed)
- Non-affiliated to national health insurance
- Person under legal protection (curatorship, guardianship)
- Person subject to a court order
- Pregnant, parturient or breast-feeding women
- Major unable to give consent
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 |
|---|---|---|
| Fasting blood testmetabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays | Biological | Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years |
| Subject interviewsocio-demographic data, medical and family history, treatment taken | Other | Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years |
| Motor assessmentMDS-UPDRS scale PART III | Other | Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years |
| Neurocognitive assessmentMoCA and MMSE scales | Other | Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years |
| Nutritional assessmentanthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skin fold, brachial circumference), bioelectrical impedancemetry (fat mass, lean mass, water mass and bone mass) | Other | Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years |
| Taste testsRecording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand) | Other | Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years |
Primary outcome
Average latency of taste-evoked potentials
Time frame: After a 2-hour fasting period
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 7 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting blood test, Subject interview and Motor assessment in people with Idiopathic Parkinson's Disease and Lewy Body Disease, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 19 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 7 Oct 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 France. 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?
Contact Vincent SCHNEIDER (03.80.29.30.89, vincent.schneider@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average latency of taste-evoked potentials (time frame: After a 2-hour fasting period). 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 7 Oct 2026.