Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000012673
Ethics application status
Approved
Date submitted
6/09/2013
Date registered
6/01/2014
Date last updated
8/06/2021
Date data sharing statement initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are Healthcare interventions Exacerbating Alzheimer's Disease? (AHEAD study)
Scientific title
The AHEAD study - Do patients with mild cognitive impairment (MCI) or dementia who undergo healthcare interventions including surgery and anaesthesia, suffer cognitive decline of an increased frequency or severity when compared to a comparable diagnostic group who do not undergo such interventions.
Secondary ID [1] 283140 0
None
Universal Trial Number (UTN)
Trial acronym
AHEAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 289994 0
Dementia 289995 0
Mild Cogntive Impairment (MCI) 289996 0
Condition category
Condition code
Neurological 290378 290378 0 0
Dementias
Surgery 290379 290379 0 0
Other surgery
Anaesthesiology 290380 290380 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of persons with MCI or mild dementia who are undergoing healthcare interventions requiring surgery and anaesthesia. Study will follow up participants for two years following surgery.
Intervention code [1] 287869 0
Not applicable
Comparator / control treatment
Persons with MCI or mild dementia who are not undergoing any healthcare interventions. Follow up will be completed with patients for two years.
Control group
Active

Outcomes
Primary outcome [1] 290406 0
Cognitive decline, as measured by neuropsychological tests including:

- Mini Mental State Examination (MMSE)
- Alzheimer's Disease Assessment Scale (ADAS-Cog)
- Controlled Oral Word Assocation Test (COWAT)
- Trail Making Test A and B
- Semantic word fluency
- Digit Symbol Substitution Test (DSST)
- Grooved Pegboard (dominant & non dominant hands)
Timepoint [1] 290406 0
Baseline, 7 days, 3, 12 and 24 months following surgery or enrolment in study (for controls).
Primary outcome [2] 290445 0
functional decline as measured by questionnaires including:

- Clinical Dementia Rating (CDR)
- Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
- AD Cooperative Study (ADCS) Activities of Daily Living Inventory
- Quality of Life Short Form 12
- ADCS - Clinician's Global Impression of Change
Timepoint [2] 290445 0
Baseline, 7 days, 3, 12 and 24 months following surgery or enrolment in study (for controls).
Secondary outcome [1] 304435 0
Identify whether patient risk factors, including cardiovascular, Apo-E genotype, postoperative delirium and Post Operative Cognitive Dysfunction (POCD) are associated with longer term deterioration.
Postoperative delirium will be measured using the Confusion Assessment Method (CAM) and POCD will be classified using the Reliable Change Index (RCI).
Timepoint [1] 304435 0
Baseline, day 3 and 7, 3, 12 and 24 months postoperatively

Eligibility
Key inclusion criteria
1. Patients aged >=60 years
2. Mild Cognitive Impairement (MCI) or very-mild to mild dementia (CDR global 0.5 - 1.0)
3. Able to provide written informed consent
4. Live within a reasonable distance of St Vincent's Hospital (for home neuropsychological assessments)
5. No contraindication to neuropsychological testing (eg. language, significant depression, deaf or blind)
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-existing neurological or clinically evident neurovascular disease (eg. stroke)
2. Severe dementia (CDR>=2)
3. Dementia known to be due to causes other than AD.
4. Non-english speaker; deafness, blindness
5. Medical co-morbidity that may lead to complications and loss to follow-up

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The hypothesis will be tested using Generalised Linear Modelling (GLM) with Clinical Dementia Rating - Sum of Boxes (CDR-SB) at 2 years as the primary outcome.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/12/2013
Actual
20/12/2013
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
252
Accrual to date
230
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7325 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 287910 0
Government body
Name [1] 287910 0
National Health and Medical Research Council
Country [1] 287910 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital
Address
PO Box 2900
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 286639 0
None
Name [1] 286639 0
Address [1] 286639 0
Country [1] 286639 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289846 0
St Vincent's Hospital HREC-A
Ethics committee address [1] 289846 0
Ethics committee country [1] 289846 0
Australia
Date submitted for ethics approval [1] 289846 0
07/08/2013
Approval date [1] 289846 0
16/09/2013
Ethics approval number [1] 289846 0
087/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42654 0
A/Prof David Scott
Address 42654 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 42654 0
Australia
Phone 42654 0
+61 3 9288 4253
Fax 42654 0
Email 42654 0
[email protected]
Contact person for public queries
Name 42655 0
Erika Fortunato
Address 42655 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 42655 0
Australia
Phone 42655 0
+61 3 9288 2072
Fax 42655 0
Email 42655 0
[email protected]
Contact person for scientific queries
Name 42656 0
Lisbeth Evered
Address 42656 0
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Country 42656 0
Australia
Phone 42656 0
+61 3 9288 2251
Fax 42656 0
Email 42656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
5669Study protocol  [email protected]
5670Informed consent form  [email protected]
5671Statistical analysis plan  [email protected]
5672Clinical study report  [email protected]
5673Ethical approval  [email protected]
5674Analytic code  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.