Nalysis of the Periodontal Microbiota in Elderly Subjects With and Without Alzheimer's Disease: a Case Control Study

Official title

Oral Bacterial and Viral Mapping by Dental Plaque in Elderly Patients With and Without Alzheimer's Disease(ORal MICrobiology in Alzheimer's Patients)

Overview

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.

Interventions

• Other sampling of dental plaque and blood sample during the treatment
  sampling of dental plaque and blood sample analysed on day 1

Primary outcome measures

• Quantification of periodontal bacterial and viral species from dental plaque samples [Time frame: day 1]

Secondary outcome measures (1)

• Oral status presence of dentures [Time frame: day 1]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

France · 1 center

• CHU de Nice — Nice

Identifiers

NCT: NCT05077618 · 21-AOI-05 · 2021-A01501-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗