Alzheimer´s DiseaseDEMANCT01695889
Is There a Relationship Between Previous Exposure to General Anesthesia and the Development of Alzheimer´s Disease?
An observational study of Alzheimer´s Disease and General Anesthesia, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The purpose of this study is to compare exposure to general anesthesia between cases with a diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical records. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer´s Disease, General Anesthesia
- How many people
- 877 participants
- Where
- 1 siteSweden
- Study dates
- May 2012to Jul 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cases from a regional Alzheimer´s disease record. Matched controls from the national population register.
Who may be able to join
- Clinical diagnosis of Alzheimer´s disease
- Previous exposure to anesthesia
Who cannot join
- Inability to retrieve medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case-control Study of Exposure to General Anesthesia and a Diagnosis of Alzheimer´s Disease Later in Life.
The purpose of this study is to compare exposure to general anesthesia between cases with a diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical records. The investigators wish to explore if there is a relationship between exposure to general anesthesia and the development of Alzheimer´s disease.
- Conditions
- Alzheimer´s Disease, General Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure to general anesthesia
Measured: Up to 20 years in retrospect
Secondary outcomes (1)
Exposure to inhaled anesthetics
Measured: Up to 20 years in retrospect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
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
- Retrospective
- Enrolment
- 877 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna-Karin Strand, MD, University Hospital, Linkoeping
- Investigators
- Christina Eintrei, professor, Study chair, University Hospital Linkoping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695889
- Sponsor's protocol ID
- DEMA-1
- Acronym
- DEMA
- Status last verified
- Mar 2016
- First submitted
- 27 Sep 2012
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study of Exposure to General Anesthesia and a Diagnosis of Alzheimer´s Disease Later in Life.
- ClinicalTrials.gov ID
- NCT01695889
- Acronym / sponsor ID
- DEMA / DEMA-1
- Conditions
- Alzheimer´s Disease, General Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 877 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 28 Sep 2012 (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.
The purpose of this study is to compare exposure to general anesthesia between cases with a diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical records. The investigators wish to explore if there is a relationship between exposure to general anesthesia and the development of Alzheimer´s disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases from a regional Alzheimer´s disease record. Matched controls from the national population register.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Alzheimer´s disease
- Previous exposure to anesthesia
Key exclusion criteria (1 listed)
- Inability to retrieve medical records
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
Exposure to general anesthesia
Time frame: Up to 20 years in retrospect
1 secondary outcome
Exposure to inhaled anesthetics
Time frame: Up to 20 years in retrospect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
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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.
Christina Eintrei, professor study chair
University Hospital Linkoping
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 General Anesthesia, run by University Hospital, Linkoeping at 1 site in Sweden.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2016. 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 Sweden. 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?
Results are not available in the source record.
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?
Exposure to general anesthesia (time frame: Up to 20 years in retrospect). 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 25 Mar 2016.