- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07110207
- Original Trial
Single-centre Descriptive Study of Taste in Frontotemporal Lobar Degeneration Through the Analysis of Taste Evoked Potentials (FRONTAL-PEG)
The FRONTAL-PEG study focuses on taste perception in frontotemporal lobar degeneration (FTLD). This neurodegenerative disease, characterised by progressive loss of nerve cells, is the second leading cause of dementia after Alzheimer's disease.
Patients with FTLD often experience olfactory disorders (= sense of smell) and eating disorders: increased appetite, increased food intake and excessive consumption of sugary foods and snacking. This often leads to excessive weight gain. These eating disorders are still poorly understood at present.
In this context, we hypothesise that an alteration in the gustatory pathway - i.e. the way in which the brain perceives taste - could contribute to the eating disorders frequently observed in frontotemporal dementia (FTD), particularly in the marked attraction to sweet foods. We therefore wish to objectively evaluate the taste response to a sweet solution (sucrose) in patients with FTLD, using taste evoked potentials (TEPs). Taste evoked potentials are a reliable and reproducible technique for assessing brain activity in response to taste stimulation. One of their advantages is that they are non-invasive.
This study will document, for the first time in this disease, the characteristics of cortical (brain) processing of taste information.
The FRONTAL-PEG study is an interventional, regional, single-centre study conducted at the Dijon University Hospital, in collaboration with the CMRR (Memory, Resources and Research Centre) and the CSGA (Centre for Taste and Food Sciences).
All investigations are carried out at the CSGA (building adjacent to the Dijon University Hospital), with the exception of blood tests, which are carried out at the Dijon University Hospital.
The total duration of participation in the study is one morning. No follow-up is planned at the end of the study.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Agnès JACQUIN-PIQUES
- Phone Number: 03 80 29 59 02
- Email: agnes.jacquin-piques@chu-dijon.fr
Study Locations
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-
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Dijon, France
- Recruiting
- Chu Dijon Bourgogne
-
Contact:
- Agnès JACQUIN-PIQUES
- Phone Number: 03 80 29 59 02
- Email: agnes.jacquin-piques@chu-dijon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Person who has given their free and informed consent
- Person of legal age
- Fasting > 2 hours before PEG measurement
- Body Mass Index (BMI) < 30 kg/m² (according to medical record data)
- DLFT: diagnostic criteria for established or probable DLFT
Exclusion Criteria:
- Persons not affiliated with or not covered by a social security scheme
- Persons subject to legal protection measures (guardianship, trusteeship)
- Persons subject to judicial protection measures
- Pregnant women, women in labour or breastfeeding women
- MMSE score < 15 and/or MoCA score < 10
- Known COVID-19 infection within 6 months prior to inclusion
- Active smokers (> 4 cigarettes per day on a regular basis)
- Subject with a pacemaker (contraindication for bioelectrical impedance analysis)
- Subject with diabetes (type 1 or type 2)
- Taking medication (during the study) that interferes with taste
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with frontotemporal lobar degeneration
|
Metabolic measurements and measurements of hormones related to food intake
Collection of socio-demographic data, medical and family history, medication
MMSE and MoCA cognitive tests
Anthropometric data (weight, height, BMI, waist circumference, hip circumference, android/gynoid ratio, triceps skinfold thickness, brachial circumference), bioelectrical impedance analysis (body fat percentage, lean body mass, body water percentage and bone mass in kg)
Recording of PEGs in response to a sucrose solution (prepared beforehand)
Triangular test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Average latency of taste evoked potentials
Time Frame: After a fasting period of at least two hours
|
After a fasting period of at least two hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JACQUIN 2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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