NCT07110207

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Aug 2025Aug 2027

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

July 31, 2025

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average latency of taste evoked potentials

    After a fasting period of at least two hours

Study Arms (1)

Patients with frontotemporal lobar degeneration

EXPERIMENTAL
Biological: Blood testOther: Interrogation of the subjectOther: Cognitive assessmentOther: Nutritional assessmentOther: Taste testsOther: Sucrose taste detection test

Interventions

Blood testBIOLOGICAL

Metabolic measurements and measurements of hormones related to food intake

Patients with frontotemporal lobar degeneration

Collection of socio-demographic data, medical and family history, medication

Patients with frontotemporal lobar degeneration

MMSE and MoCA cognitive tests

Patients with frontotemporal lobar degeneration

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)

Patients with frontotemporal lobar degeneration

Recording of PEGs in response to a sucrose solution (prepared beforehand)

Patients with frontotemporal lobar degeneration

Triangular test

Patients with frontotemporal lobar degeneration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

Frontotemporal Lobar Degeneration

Interventions

Hematologic TestsMental Status and Dementia TestsNutrition Assessment

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesNeuropsychological TestsPsychological TestsBehavioral Disciplines and ActivitiesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start

August 18, 2025

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

August 24, 2025

Record last verified: 2025-08

Locations