Ireland
--:--IST
Recruiting Not applicable

Single-center Study of Gustation in Idiopathic Parkinson's Disease and Lewy Body Disease Using Gustatory Evoked Potential Analysis

NCT06439355 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-05-27
Last updated
2026-10-07

Condition(s) studied

Idiopathic Parkinson's Disease and Lewy Body Disease

Investigational drug(s) / intervention(s)

Fasting blood testSubject interviewMotor assessmentNeurocognitive assessmentNutritional assessmentTaste tests

Fasting blood test: metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays

Subject interview: socio-demographic data, medical and family history, treatment taken

Motor assessment: MDS-UPDRS scale PART III

Neurocognitive assessment: MoCA and MMSE scales

Nutritional assessment: 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 tests: Recording of PEGs in response to a sucrose solution and a free fatty acid solution (prepared beforehand)

Study 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 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. * 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 Exclusion Criteria: * 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 * 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

Primary outcome measure(s)

  • Average latency of taste-evoked potentials — After a 2-hour fasting period

Trial sites (1)

FacilityCityRegionStatus
Chu Dijon Bourgogne Dijon France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06439355 on ClinicalTrials.gov ↗ ← All trials in France