NCT05077618 Nalysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study
| NCT ID | NCT05077618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Periodontitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 94 participants |
| Start Date | 2023-01-30 |
| Primary Completion | 2023-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 94 participants in total. It began in 2023-01-30 with a primary completion date of 2023-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The neurological disorders that accompany aging represent a major public health problem. The management of these diseases is a major medical and social priority. This project is based on the assumption that the oral cavity represents a privileged observation space to address these issues. The mouth is a site of easy access for painless sampling; there is therefore a major interest in identifying early oral infectious markers of the development or evolution of senile dementia. In addition to the interest of an early oral diagnosis, the mapping of the oral microbial flora in the demented elderly would allow a better understanding, prevention or even control of the evolution of neurodegenerative diseases. The final objective of our approach is to characterize the oral pathogens, or more probably the group of oral pathogens, which are significantly associated with Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria: * ge greater than or equal to 70 years old * Patient (or trusted person) having read and understood the study information note and signed the informed consent form * Membership in a social security scheme * for cases : Diagnosis of possible or probable Alzheimer's disease according to the DSM-V Exclusion Criteria: * Presence of a neurodegenerative pathology (excluding Alzheimer's disease for cases) * Presence of a neurocognitive disorder (excluding Alzheimer's disease for the cases) * Patient with or having had any kind of cancer, including oral or aerodigestive tract * Patients with or having had autoimmune diseases (HIV, hepatitis) * Patients with inflammatory diseases (such as rheumatoid arthritis (RA) or Gougerot-Sjogren's syndrome (GSJ)) * Patients with severe haemopathy * Patients with severe acute or chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, pulmonary, neuropsychiatric pathologies, judged by the investigator to be incompatible with the study, as all these pathologies may interfere with the results of the oral flora sampling * Patients who have undergone oral surgery in the two months prior to sampling * Patients treated with oral retinoids, bisphosphonates, oral anticoagulants or anticonvulsants * Patients who have had anti-cancer or immunosuppressive chemotherapy within the last 6 months * Patient who has had antibiotic or anti-inflammatory treatment in the last 4 weeks * A history of treatments (drugs and probiotics) taken in the month prior to sampling will be taken, as well as a record of toxic habits (tobacco, alcohol, other)
Contact & Investigator
Leslie BORSA
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Frequently Asked Questions
Who can join the NCT05077618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05077618 currently recruiting?
Yes, NCT05077618 is actively recruiting participants. Contact the research team at causeret.m@chu-nice.fr for enrollment information.
Where is the NCT05077618 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT05077618 clinical trial?
NCT05077618 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is Leslie BORSA at Centre Hospitalier Universitaire de Nice. The trial plans to enroll 94 participants.