NCT05557617

Brief Summary

The study is designed to inquire whether the presence of periodontitis and different periodontopathogenic bacterial strains are associated with dementia diagnosis and with the degree of cognitive impairment in participants evaluated at a Memory clinic (Minnesmottagning). Specifically, by analyzing cerebrospinal fluid, the investigators intend to clarify whether the alleged mechanisms for Porphyromonas gingivalis in the aetiology of Alzheimer disease (AD) are supported in a Swedish population and whether they are specific for Porphyromonas gingivalis (as compared to other periodontopathogenic bacteria) and Alzheimer type dementia (as compared to other etiological dementia types), respectively.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

4.2 years

First QC Date

September 23, 2022

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Bacteriological findings in relation to neurocognitive outcome

    The presence of DNA, antibodies and toxins from selected bacterial species in biobank stored cerebrospinal fluid.

    2022-10-01 - 2023-12-31

  • Periodontitis in relation to neurocognitive outcome

    Retrospectively collected clinical and radiographic periodontal status

    2022-10-01 - 2023-12-31

Study Arms (1)

Memory clinic cohort

A cohort of 120 individuals that has been investigated for cognitive impairment at the Memory Clinic, Department of Geriatric Medicine, Örebro University Hospital and from which a sample of cerebrospinal fluid has been stored in biobank.

Eligibility Criteria

Age25 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A cohort of 120 patients that has been investigated for cognitive impairment at the Memory Clinic, Department of Geriatric Medicine, Örebro University Hospital and from which a sample of cerebrospinal fluid has been stored in biobank.

You may qualify if:

  • \- Any person that has been investigated for possible cognitive impairment at Minnesmottagningen, Department of Geriatric Medicine, Örebro University Hospital, and has a CSF sample stored in the biobank. This includes patients who received a diagnosis of dementia (major cognitive disorder) and patients not so diagnosed.

You may not qualify if:

  • No CSF sample available in biobank
  • Incomplete or unavailable clinical and radiological data in medical and dental records, concerning e.g. cognitive tests and AD-biomarker analyses
  • Dementia with known etiological diagnosis, e.g. dementia due to alcohol use disorder or traumatic brain injury.
  • Creutzfeldt-Jakob disease or other transmissible prion disease
  • Non-consenting persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Örebro county

Örebro, Örebro County, 701 82, Sweden

Location

Related Publications (1)

  • Dominy SS, Lynch C, Ermini F, Benedyk M, Marczyk A, Konradi A, Nguyen M, Haditsch U, Raha D, Griffin C, Holsinger LJ, Arastu-Kapur S, Kaba S, Lee A, Ryder MI, Potempa B, Mydel P, Hellvard A, Adamowicz K, Hasturk H, Walker GD, Reynolds EC, Faull RLM, Curtis MA, Dragunow M, Potempa J. Porphyromonas gingivalis in Alzheimer's disease brains: Evidence for disease causation and treatment with small-molecule inhibitors. Sci Adv. 2019 Jan 23;5(1):eaau3333. doi: 10.1126/sciadv.aau3333. eCollection 2019 Jan.

    PMID: 30746447BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid saved at biobank

MeSH Terms

Conditions

Alzheimer DiseaseDementiaPeriodontitis

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Susanne Bejerot, Professor

    Region Örebro County

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2022

First Posted

September 28, 2022

Study Start

October 30, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations