Clinical trial NCT04869904: Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)
Official title: Analysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients coming to the Nice University Hospital (Autonomy Rehabilitation and Ageing Unit) for a memory consultation or a frailty screening

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:

* Age 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)

Primary outcomes:
measure: Quantification of periodontal bacterial and viral species from dental plaque samples
timeFrame: 9 months
Secondary outcomes:
measure: Oral status presence of dentures
timeFrame: 9 Months
measure: Oral status presence of dentures
timeFrame: 9 Months
measure: Oral status masticatory coefficient
timeFrame: 9 Months
measure: Oral status mobilities
timeFrame: 1 day
measure: Oral status caries involvement
timeFrame: 1 day
measure: Periodontal status: pocket depth (PPS)
timeFrame: 9 months
measure: Periodontal status: clinical attachment (CAL)
timeFrame: 9 months
measure: Periodontal status: bleeding on probing (BOP):
timeFrame: 9 months
measure: Periodontal status: plaque index (PI)
timeFrame: 9 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References: