ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000493842

Ethics application status

Approved

Date submitted

20/04/2012

Date registered

7/05/2012

Date last updated

19/02/2020

Date data sharing statement initially provided

19/02/2020

Date results provided

19/02/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Alzheimer's disease, cognition and cerebrospinal fluid: Are they associated?

Scientific title

An observational study of Alzheimer's disease, cognition and cerebrospinal fluid: Are they associated?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1126-5641

Trial acronym

CAPACITY study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Alzheimer's Disease

Effect of anaesthesia and surgery on cognition

Cerebrospinal fluid (CSF) predictors of cognitive change and Alzheimer's diseae

Condition category

Condition code

Anaesthesiology

Anaesthetics

Neurological

Alzheimer's disease

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is an observational study which will identify if surgery and anaesthesia increase the risk of adverse central nervous system outcomes, including acceleration of the Alzheimer's disease process and subsequent earlier expression. Cognition and function will be measured for 18 months postoperatively to identify any change including signs and symptoms of dementia.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

The effect of anaesthesia and surgery will be assessed by comparing the change in cognition in surgical patients with the change in cognition observed in patients in the AIBL study (without surgical intervention) who have been matched for age, gender, baseline cognition and CSF profile.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To determine the extent to which a pre-operative CSF signature of Alzheimer's disease (amyloid beta 1-42; total-tau and phospho-tau) predicts postoperative cognitive dysfunction (POCD) and increase in clinical dementia rating (CDR) scale in elderly patients who receive general anaesthesia for orthopaedic surgery.

Timepoint [1]

Baseline, 3, 12 and 18 months postoperatively

Secondary outcome [1]

To identify an association between POCD, Mild Cognitive Impairment (MCI) and dementia. Baseline cognitive and functional data collected at baseline assessment will be compared with 3, 12 and 18 month follow-ups cognitive and functional assessment to measure cognitive outcomes and risk of dementia.

Timepoint [1]

Baseline, 3, 12 and 18 months postoperatively

Secondary outcome [2]

To identify risk factors for POCD and progressive cognitive decline (MCI and dementia) after anaesthesia and surgery.
Medical history details of risk factors will be collected from the patient at baseline and verified by the patient's medical record.

Timepoint [2]

Baseline and 3 months postoperatively

Secondary outcome [3]

Exploratory analyses of the blood samples will be undertaken to identify known and unknown biomarkers for cognition and neuronal injury.

Timepoint [3]

baseline, 30 min, 6, 24 and 48 hours post surgery.

Eligibility

Key inclusion criteria

Patients aged 60y or more who are scheduled for elective total hip joint replacement (THJR) or total knee joint replacement (TKJR) who do not have neurological deficit; give informed consent; have no contraindication to neuropsychological testing; and reside in accessible proximity to the hospital to enable investigators to administer neuropsychological testing at patients' home.

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Pre-existing neurological or clinically evident neurovascular disease (eg. stroke); Clnical Dementia Rating score >=1 (exclude frank dementia); anticipated difficulty with neuropsychological assessment, such as English not being the prime language, blindness, deafness; associated medical problems that may lead to significant loss to follow-up (ASA physical status IV or higher); geographical remoteness.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2012

Actual

11/06/2013

Date of last participant enrolment

Anticipated

Actual

7/08/2014

Date of last data collection

Anticipated

Actual

4/04/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Alzheimer's Australia Dementia Research Foundation Limited

Address [1]

1 Frewin Place
Scullin
ACT 2614

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council

Address [2]

GPO Box 1421
Canberra ACT 2601

Country [2]

Australia

Primary sponsor type

Hospital

Name

St. Vincent's Hospital

Address

PO Box 2900
Fitzroy
VIC 3065

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Lisbeth Evered

Address [1]

Centre for Anaesthesia and Cognitive Function
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

David Scott

Address [1]

Centre for Anaesthesia and Cognitive Function
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Brendan Silbert

Address [2]

Centre for Anaesthesia and Cognitive Function
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St. Vincent's Hospital Human Research Ethics Committee

Ethics committee address [1]

St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2012

Approval date [1]

08/05/2012

Ethics approval number [1]

149/11

Summary

Brief summary

The overarching hypothesis for this study is that in older adults who undergo surgery, occult or preclinical Alzheimer’s Disease (AD) increases the risk of adverse central nervous system (CNS) outcomes, including acceleration of the AD disease process itself and subsequent earlier clinical expression. The specific hypotheses are: 
1.	In older people undergoing elective orthopaedic surgery, the presence of a cerebrospinal fluid (CSF) signature of Alzheimer’s Disease (AD) at baseline will be associated with a greater incidence and or severity of decline in Clinical Dementia Rating scale at 18 months post-operatively, compared with a non-surgical group with a CSF signature of AD and equivalent baseline cognition.
2.	At baseline, a CSF signature of AD in surgical patients will be associated with a higher incidence of PostOperative Cognitive Dysfunction (POCD) and functional change at 3, 12, and 18 months post-operatively compared to surgical patients without the CSF AD signature.
3.	Individuals classified with POCD will be at higher risk of conversion from cognitively normal to MCI or to dementia, or from MCI to dementia, compared with those who are not classified with POCD.

Trial website

www.cognition.org.au

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Brendan Silbert

Address

St Vincent's Hospital
PO Box 2900
Fitzroy 3065
Vic

Country

Australia

Phone

+61 9288 4253

Fax

[email protected]

Contact person for public queries

Name

Lisbeth Evered

Address

Centre for Anaesthesia and Cognitive Function
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 9288 2251

Fax

+61 3 9288 4255

[email protected]

Contact person for scientific queries

Name

Lisbeth Evered

Address

Centre for Anaesthesia and Cognitive Function
Department of Anaesthesia
St. Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065

Country

Australia

Phone

+61 3 9288 2251

Fax

+61 3 9288 4255

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

It is intended that the IPD will be made available for this trial but specific details have not yet been ascertained.

What supporting documents are/will be available?

Doc. No.	Type	Email
6960	Study protocol	[email protected]
6961	Statistical analysis plan	[email protected]
6962	Informed consent form	[email protected]
6963	Clinical study report	[email protected]
6964	Ethical approval	[email protected]
6965	Analytic code	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Cerebrospinal fluid sampling for research of Alzheimer's disease and other neurodegenerative diseases when lumbar punctures are performed by anaesthetists.	2022	https://dx.doi.org/10.1136/bmjno-2022-000335

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically