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

NCT05077618 | Recruiting

• 2 other identifiers: 21-AOI-052021-A01501-40
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Oral status presence of dentures

  day 1

Study Arms (2)

patients with Alzheimer's disease

47 cases (patients with Alzheimer's disease)

Other: sampling of dental plaque and blood sample during the treatment

patients without Alzheimer's disease

47 patients without Alzheimer's disease

Interventions

sampling of dental plaque and blood sample during the treatment OTHER

sampling of dental plaque and blood sample analysed on day 1

patients with Alzheimer's disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, CHU de NICE, 06000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample and plaque

MeSH Terms

Conditions

Periodontitis; Alzheimer Disease

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Leslie BORSA

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Borsa

CONTACT

0492034702; causeret.m@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 14, 2021
• Study Start: January 30, 2023
• Primary Completion: January 30, 2023
• Study Completion: July 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)