Clinical trial

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

ID

Name

SCHNEIDER J'InvEST-I 2023

Description

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.

Trial arms

Trial start

2024-05-27

Estimated PCD

2026-05-01

Trial end

2026-05-01

Status

Recruiting

Treatment

Fasting blood test

metabolic assays determination of food intake hormones oxidative stress and neurodegeneration marker assays

Arms:

Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years

Subject interview

socio-demographic data, medical and family history, treatment taken

Arms:

Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years

Motor assessment

MDS-UPDRS scale PART III

Arms:

Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years

Neurocognitive assessment

MoCA and MMSE scales

Arms:

Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years

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)

Arms:

Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years

Taste tests

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

Arms:

Healthy volunteers, Patients with Idiopathic Parkinson's Disease (IPD) of course ≤ 3 years, Patients with Lewy body disease (LBD) progressing ≤ 3 years

Size

66

Primary endpoint

Average latency of taste-evoked potentials

After a 2-hour fasting period

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}

Updated at

2024-06-07

1 organization

Organization

Centre Hospitalier Universitaire Dijon