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

NCT ID: NCT05077618

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-30

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis Alzheimer Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with Alzheimer's disease

47 cases (patients with Alzheimer's disease)

sampling of dental plaque and blood sample during the treatment

Intervention Type OTHER

sampling of dental plaque and blood sample analysed on day 1

patients without Alzheimer's disease

47 patients without Alzheimer's disease

No interventions assigned to this group

Interventions

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sampling of dental plaque and blood sample during the treatment

sampling of dental plaque and blood sample analysed on day 1

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie BORSA

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, CHU de NICE, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Leslie Borsa

Role: CONTACT

0492034702

Facility Contacts

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Role: primary

0492034702

Other Identifiers

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2021-A01501-40

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-AOI-05

Identifier Type: -

Identifier Source: org_study_id

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