Alzheimer's DiseasePGNEURONCT02109705
Porphyromonas Gingivalis and Alzheimer's Disease
An observational study of Alzheimer's Disease and Dementia, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia, Periodontitis
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2014to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 Patients with Dementia (30 with Alzheimer's and 30 with another Dementia) 30 cognitive healthy patients
Who may be able to join
- age 40-70
- caucasian origin
- dementia (Alzheimer's or other dementia)
- cognitive healthy (need for spinal anesthesia)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Porphyromonas Gingivalis - a Responsible Pathogen in Alzheimer's Disease?
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.
- Conditions
- Alzheimer's Disease, Dementia, Periodontitis
- Medical subject headings
- Alzheimer Disease, Dementia, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Not described | |
| other Dementia | Not described | |
| cognitive healthy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax Antibody Levels against Gingipains
laboratory analysis
Measured: Baseline
Secondary outcomes (1)
Cmax Beta-Amyloid
laboratory analysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Oliver Laugisch, Dr med dent MAS, Principal investigator, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109705
- Sponsor's protocol ID
- PG001
- Acronym
- PGNEURO
- Status last verified
- Dec 2014
- First submitted
- 31 Mar 2014
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Porphyromonas Gingivalis - a Responsible Pathogen in Alzheimer's Disease?
- ClinicalTrials.gov ID
- NCT02109705
- Acronym / sponsor ID
- PGNEURO / PG001
- Conditions
- Alzheimer's Disease, Dementia, Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | – | – |
| other Dementia | – | – |
| cognitive healthy | – | – |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 Patients with Dementia (30 with Alzheimer's and 30 with another Dementia) 30 cognitive healthy patients
Key inclusion criteria (4 listed)
- age 40-70
- caucasian origin
- dementia (Alzheimer's or other dementia)
- cognitive healthy (need for spinal anesthesia)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cmax Antibody Levels against Gingipains
Time frame: Baseline
laboratory analysis
1 secondary outcome
Cmax Beta-Amyloid
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Laugisch, Dr med dent MAS principal investigator
Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Dementia, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax Antibody Levels against Gingipains (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.