Is There a Relationship Between Previous Exposure to Gene... | NCT01695889

Studies
Is There a Relationship Between Previous Exposure to General Anesthesia and the Development of Alzheimer´s Disease?

NCT01695889

Sponsor

University Hospital, Linkoeping

Status

Unknown status

Last Update Posted

Mar 25, 2016Estimated

Enrollment

877Actual

Phase

Not provided

Conditions

Alzheimer´s Disease
General Anesthesia

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Sep 27, 2012

First Posted Date

Sep 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anna-Karin Strand, MD, Specialist in Anaesthesiology and Intensive Care, University Hospital, LinkoepingPrincipal Investigator

Lead Sponsor

University Hospital, LinkoepingOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The investigators wish to explore if there is a relationship between exposure to general anesthesia and the development of Alzheimer´s disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

877Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Exposure to general anesthesia		Up to 20 years in retrospect

Secondary Outcomes

Measure	Description	Time Frame
Exposure to inhaled anesthetics		Up to 20 years in retrospect

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Alzheimer´s disease
Previous exposure to anesthesia

Exclusion Criteria:

Inability to retrieve medical records

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Cases from a regional Alzheimer´s disease record. Matched controls from the national population register.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina Eintrei, professor	University Hospital Linkoping	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Linköping	Linkoping	58185	Sweden