Nalysis of the Periodontal Microbiota in Elderly Subjects with and Without Alzheimer's Disease: a Case Control Study (ORAMICAL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis; Alzheimer Disease
• Intervention / Treatment: Other: sampling of dental plaque and blood sample during the treatment

• Study Type: Observational
• Enrollment (Estimated): 94

Contacts and Locations

• Study Contact: Name: Leslie Borsa; Phone Number: 0492034702; Email: causeret.m@chu-nice.fr

Study Locations

• France
  • Chu de Nice
    • Nice, Chu de Nice, France, 06000
      • Recruiting
      • CHU de Nice
      • Contact: Phone Number: 0492034702; Email: borsa.s@chu-nice.fr
      • Contact: Leslie BORSA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients coming to the Nice University Hospital (Autonomy Rehabilitation and Ageing Unit) for a memory consultation or a frailty screening

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with Alzheimer's disease; 47 cases (patients with Alzheimer's disease)	Other: sampling of dental plaque and blood sample during the treatment; sampling of dental plaque and blood sample analysed on day 1
patients without Alzheimer's disease; 47 patients without Alzheimer's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of periodontal bacterial and viral species from dental plaque samples	Quantification of periodontal bacterial and viral species by microfluidic multiplex PCR-Biomark HD system Microfluidigm 9 Herpes viruses = HSV-1 and 2 (or HHV-1 and -2), VZV (or HHV-3), EBV (or HHV-4), CMV (or HHV-5), HHV-6A, HHV-6B, HHV-7, HHV-8 (or Kaposi virus) 16 periodontal bacteria = Porphyromonas gingivalis, Tannerella forsythensis, Treponema denticola, Prevotella intermedia, Campylobacter rectus, Fusobacterium nucleatum, Prevotella nigrescens, Eubacterium nodatum, Peptostreptococcus micros, Prevotella melaninogenica, Aa, Actinomyces naeslundii, Eikenella corrodens, Streptococcus mitis, Streptococcus oralis, Streptococcus sanguis	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral status presence of dentures	presence of dentures: Yes/No masticatory coefficient: Coefficient from 1 to 5% assigned to each tooth according to its function, sum of all coefficients gives the result mobilities: Mühlemann index (from 0 to 3) caries involvement: DMFT	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Leslie BORSA, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Actual): January 30, 2023
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Periodontitis; Alzheimer Disease
• Other Study ID Numbers: 21-AOI-05; 2021-A01501-40 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No