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Porphyromonas Gingivalis and Alzheimer`s Disease (PGNEURO)

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ClinicalTrials.gov Identifier: NCT02109705
Recruitment Status : Unknown
Verified December 2014 by University Hospital Muenster.
Recruitment status was:  Recruiting
First Posted : April 10, 2014
Last Update Posted : December 9, 2014
University of Bern
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:
With this study the investigators would like to analyze the the role of periodontal disease and especially the role of Porphyromonas gingivalis in initiation and progression of Alzheimer`s Disease.

Condition or disease
Alzheimer`s Disease Dementia Periodontitis

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Porphyromonas Gingivalis - a Responsible Pathogen in Alzheimer`s Disease?
Study Start Date : March 2014
Estimated Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Alzheimer`s Disease
other Dementia
cognitive healthy

Primary Outcome Measures :
  1. Cmax Antibody Levels against Gingipains [ Time Frame: Baseline ]
    laboratory analysis

Secondary Outcome Measures :
  1. Cmax Beta-Amyloid [ Time Frame: Baseline ]
    laboratory analysis

Other Outcome Measures:
  1. Cmax: Periodontal pathogens [ Time Frame: Baseline ]
    laboratory analysis

  2. U enzyme activities [ Time Frame: Baseline ]
    laboratory analysis

  3. Cmax: inflammatory cytokines [ Time Frame: Baseline ]
    laboratory analysis

Biospecimen Retention:   Samples With DNA
GCF, Liquor, Serum

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
60 Patients with Dementia (30 with Alzheimer`s and 30 with another Dementia) 30 cognitive healthy patients

Inclusion Criteria:

  • age 40-70
  • caucasian origin
  • dementia (Alzheimer`s or other dementia)
  • cognitive healthy (need for spinal anesthesia)

Exclusion Criteria:

  • use of antibiotics within las 6 months
  • pregnancy
  • another illness explaining the symptoms in a better way
  • smoking (>10 cigarettes)
  • patients who have a legal custodian

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109705

Contact: Oliver Laugisch, Dr med dent, MAS +49 (0)251 8347064 Oliver.Laugisch@ukmuenster.de

Department of Periodontology Recruiting
Muenster, Germany, 48143
Contact: Laugisch Oliver, Dr med dent MAS    +49 (0) 251 8347064    Oliver.Laugisch@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
University of Bern
Principal Investigator: Oliver Laugisch, Dr med dent MAS Department of Periodontology

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT02109705     History of Changes
Other Study ID Numbers: PG001
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases