NCT02409082

Brief Summary

The investigators explore the presence of AD factors beta-amyloid and tau in CSF and plasma to verify AD diagnosis in patients with acute hip fracture. Clinical dementia test is performed prior to operation. Blood samples and CSF samples are collected at surgery and blood samples are collected postoperatively at intervals. Mortality is assessed at 30 days, 3 months and 1 year. Morbidity is assessed at , 3 months and \>1 year. Neuromarkers specifically addressing the inflammatory component are to be analyzed and correlated to outcome together with AD markers, as above.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 6, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2016

Completed
Last Updated

April 26, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

March 25, 2015

Last Update Submit

April 25, 2017

Conditions

Alzheimers DiseaseInflammationHip Fracture

Outcome Measures

Primary Outcomes (1)

  • Mortality and morbidity

    interview by phone and death registration

    1year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with an acute hip fracture receiving a spinal anesthesia

You may qualify if:

  • Hip fracture with a planed spinal anesthesia

You may not qualify if:

  • Not receiving a spinal anesthesia i.e. no CSF is available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, Västra Götaland County, 431 80, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

AD correlated factors like betamayloid and tau as well as interleukins

MeSH Terms

Conditions

Alzheimer DiseaseInflammationHip Fractures

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Bengt M Nellgard, MD PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor/MD/PhD

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 6, 2015

Study Start

September 11, 2013

Primary Completion

June 22, 2015

Study Completion

December 20, 2016

Last Updated

April 26, 2017

Record last verified: 2017-04

Locations

SE(1)