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

NCT06439355 | Recruiting

• 1 other identifier: SCHNEIDER J'InvEST-I 2023
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Parkinson's Disease and Lewy Body Disease

Outcome Measures

Primary Outcomes (1)

• Average latency of taste-evoked potentials

  After a 2-hour fasting period

Study Arms (3)

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

Interventions

Fasting blood test BIOLOGICAL

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

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

Subject interview OTHER

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

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

Motor assessment OTHER

MDS-UPDRS scale PART III

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

Neurocognitive assessment OTHER

MoCA and MMSE scales

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

Nutritional assessment OTHER

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)

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

Taste tests OTHER

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Lewy Body Disease

Interventions

Mental Status and Dementia Tests; Nutrition Assessment

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Vincent SCHNEIDER

CONTACT

03.80.29.30.89; vincent.schneider@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: May 27, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

FR (1)