Trials / Recruiting
RecruitingNCT05888961
Single-center Prospective Longitudinal Study of Taste in Patients With Cognitive Disorders at Different Stages of Severity (Isolated Cognitive Complaint, Minor or Major Neurocognitive Alzheimer-type Disorders) by Analysis of Gustatory Evoked Potentials
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The aim of the MAPEG 2 study is to explore gustatory function and to follow its evolution in the 4 following groups of participants: * Healthy subjects * Participants with isolated cognitive complaint * Participants with minor neurocognitive disorder * Participants with mild and moderate Alzheimer-type major neurocognitive disorders For this purpose, we want to compare the results of the following tests: * Subjective taste tests (tasting solutions, answering food preference questionnaires), * Gustatory evoked potential (GEP) parameters, recorded by electrodes placed on the scalp, * And nutritional parameters (hormones of food intake by blood test, measurement of the global body composition). Identifying and following the evolution of early taste disorders in case of cognitive disorders could improve the diagnosis of Alzheimer\'s disease in two ways: * To allow an early diagnosis of Alzheimer\'s disease, and thus improve its management, * To define groups of subjects at risk of developing Alzheimer\'s disease in later years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Blood samples | Fasting at the first session for hormonal measurements of leptin, insulin, acylated and non-acylated ghrelin, serotonin, albumin, protidemia and blood glucose. Repeated at 6 and 12 months for follow-up |
| OTHER | Interviewing the subject and scales | Collection of sociodemographic data, personal and family neurological history, treatments, MADRS depression scale and CDR autonomy scale. Carried out at the 1st session |
| OTHER | Neurocognitive evaluation | cognitive complaint questionnaire (CCQ), taste, smell, MoCA and MMSE (if not performed in the previous 6 months) Carried out at the 1st session. Repeated at 6 and 12 months for follow-up. |
| OTHER | Taste tests | Sweet and salty flavors at the 1st session and acid and umami flavors at the 2nd session. Repeated at 6 and 12 months for follow-up. Placement of electrodes on the scalp, recording of gustatory evoked potentials, subjective gustatory evaluation by means of visual analogue scales rated from 0 to 10, identification and naming of each of the primary flavors |
| OTHER | Computerized food preference questionnaires | Performed at the 1st session on a tactile tablet. Repeated at 6 and 12 months for follow-up. |
| OTHER | Nutritional status - body composition | Measurement of anthropometric data, bioelectrical impedancemetry (measurement of fat mass, lean mass, water mass and bone mass in kg), measurement of blood pressure and heart rate Performed at the 2nd session Repeated at 6 and 12 months for follow-up. |
Timeline
- Start date
- 2023-06-12
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
- First posted
- 2023-06-05
- Last updated
- 2025-07-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05888961. Inclusion in this directory is not an endorsement.