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Trial registered on ANZCTR


Registration number
ACTRN12616001581459
Ethics application status
Approved
Date submitted
10/10/2016
Date registered
16/11/2016
Date last updated
28/07/2024
Date data sharing statement initially provided
13/04/2022
Date results provided
17/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Longitudinal study of early Alzheimer's disease using genetics, brain imaging and behavioural assessments.
Scientific title
Prospective Imaging Study of Ageing: Genes, Brain and Behaviour
Secondary ID [1] 290176 0
Nil
Universal Trial Number (UTN)
NIL
Trial acronym
PISA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 300315 0
Mild cognitive impairment 300316 0
Alzheimer's disease 300664 0
Condition category
Condition code
Neurological 300180 300180 0 0
Dementias
Neurological 300181 300181 0 0
Alzheimer's disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There will be 2 exposure groups in this study:
Group 1: Patients with Alzheimer’s disease
Group 2: Patients with amnestic mild cognitive impairment

Participants will complete a PET Imaging exam, MRI exam, neuropsychological assessment and provide a blood sample twice within a 5-year period, with a 2-year interval between each set of tests. Participants will also be asked to wear a smart sensing device periodically over the 5-year study period.Smart sensing wrist device which will record movement profile and heart rate. Participants are asked to wear the device for a minimum of 5days of each month, for the duration of the study.
Intervention code [1] 295933 0
Early Detection / Screening
Comparator / control treatment
Healthy controls will complete a PET Imaging exam, MRI exam, neuropsychological assessment and provide a blood sample twice within a 5-year period, with a 2-year interval between each set of tests. Participants will also be asked to wear a smart sensing watch periodically for the 5-year study period.
Control group
Active

Outcomes
Primary outcome [1] 299667 0
To measure beta-amyloid accumulation in the brain via PET Imaging. Standardized uptake values (SUV) will be calculated for all brain regions examined and SUV ratios (SUVR) will be generated by dividing all regional SUV by the cerebellar cortex SUV. Region of interest measurements will be averaged across both hemispheres. Neocortical amyloid burden will be expressed as the average SUVR of the area-weighted mean of frontal, superior parietal, lateral temporal, lateral occipital, and anterior and posterior cingulate regions. PET data will be corrected for partial volume effects using a 3 compartment model.
Timepoint [1] 299667 0
Participants will undergo 2 PET Imaging Exams with a 2 year interval between each exam.
Secondary outcome [1] 327777 0
Measuring biological changes in the brain structure and function via MRI scan.

Timepoint [1] 327777 0
Two MRI scans with a 2 year interval between each scan
Secondary outcome [2] 328599 0
Routine biochemistry -biochemistry measurements taken:
Urea
Creatinine
Electrolytes
Liver function tests
Cholesterol
Riglycerides
Glucose
CRP
Timepoint [2] 328599 0
2 blood sample collections with a 2 year interval between each collection
Secondary outcome [3] 328600 0
Comprehensive neuropsychological testing using validated measures to assess memory and cognition:
1. Wechsler Abbreviated Scale of Intelligence – II
2. Rey Auditory Verbal Learning Test
3. Rey Complex Figure Test
4. National Adult Reading Test -2nd Edition
5. Trail making Test
6. Stroop Test
This is a composite secondary outcome.
Timepoint [3] 328600 0
Baseline and follow-up neuropsych assessments with a 2 year interval between each assessment.

Secondary outcome [4] 328601 0
Evaluating participants' lifestyle factors via smart sensing devices.
Smart sensing wrist device which will record movement profile and heart rate. Participants are asked to wear the device for a minimum of 5days of each month, for the duration of the study. Movement profile and heart rate combined analyses to assess lifestyle factors. This is a composite secondary outcome.
Timepoint [4] 328601 0
Participants are asked to wear the device periodically over 5 years.
Secondary outcome [5] 328954 0
SNP analysis
Timepoint [5] 328954 0
2 blood sample collections with a 2 year interval between each collection

Eligibility
Key inclusion criteria
Overall Study:
aged between the ages of 40 and 80
fluent in English
clinical diagnosis of Alzheimer’s disease (Group 1)
OR
meet a research consensus classification of amnestic MCI (Group 2)
OR
No current or past history of neurological conditions and consented to participate in GWAS studies at QIMR Berghofer (with existing GWAS information + consent to participate in other HREC approved studies).
Completed an MRI exam

Neuropsychological testing and Blood sample collection:
Participants who have met the overall study inclusion criteria will be recruited into these components of the study.

MRI Imaging
overall study inclusion criteria
MRI clearance
All participants who have been granted MRI clearance outlined in the Metals Safety Questionnaire, and have met the inclusion criteria for the Overall study will be included in this component.

PET Imaging:
Participants who have completed the MRI exam and have met the inclusion criteria for the overall study may be recruited into this component of the study.

Smart Sensing Study:
All participants who own a smart phone, have completed all other testing components and have met the inclusion criteria for the overall study may be recruited into this component of the study.

Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Overall study:
*Inability to provide formal consent
*Any significant neurological disease (other than Alzheimer's disease) or history of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities
*Longstanding (>10 years) history of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
*History of major depression, bipolar disorder or schizophrenia that puts assessment of cognitive impairment into question
*Any significant disease or unstable medical condition that could affect neuropsychological testing (i.e., chronic renal failure, chronic hepatic disease, severe pulmonary disease)
*History of brain injury with significant sequelae (i.e. haemorrhage, oedema, hypoxia) or invasive neurosurgery.

Neuropsychological testing and Blood sample collection:
Participants who have not met any of the exclusion criteria outlined in the Overall Study will be recruited into these components of the study.
Excluded from MRI imaging
*presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, metallic fragments near the eyes or spinal cord, or cochlear implant. (Dental fillings do not present a risk for MRI).

Excluded from PET Imaging:
*Those who are pregnant or breastfeeding
*extensive white matter lesions or other neurological conditions are detected at MRI
*Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, metallic fragments near the eyes or spinal cord, or cochlear implant. (Dental fillings do not present a risk for MRI).
*History of hypersensitivity reaction to Flutemetamol F18, or any other inactive ingredient in Flutemetamol F18
Smart Sensing Study:
*Participants who do not own a smartphone will not be invited to complete this component of the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/11/2016
Actual
1/06/2017
Date of last participant enrolment
Anticipated
1/11/2018
Actual
10/03/2021
Date of last data collection
Anticipated
22/09/2022
Actual
15/06/2022
Sample size
Target
400
Accrual to date
Final
265
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294643 0
Government body
Name [1] 294643 0
National Health & Medical Research Council (NHMRC)
Country [1] 294643 0
Australia
Primary sponsor type
Other
Name
QIMR Berghofer Medical Research Institute
Address
300 Herston Rd, Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 293507 0
None
Name [1] 293507 0
Address [1] 293507 0
Country [1] 293507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296080 0
QIMR Berghofer Human REsearch Ethics Committee
Ethics committee address [1] 296080 0
Ethics committee country [1] 296080 0
Australia
Date submitted for ethics approval [1] 296080 0
26/07/2016
Approval date [1] 296080 0
Ethics approval number [1] 296080 0
P2193
Ethics committee name [2] 296081 0
Royal Brisbane & Women’s Hospital Human Research Ethics Committee
Ethics committee address [2] 296081 0
Ethics committee country [2] 296081 0
Australia
Date submitted for ethics approval [2] 296081 0
Approval date [2] 296081 0
04/05/2016
Ethics approval number [2] 296081 0
HREC/16/QRBW/104

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

Contacts
Principal investigator
Name 67910 0
Prof Nick Martin
Address 67910 0
QIMR Berghofer Medical Research Institute
300 Herston Road, Herston 4006 QLD
Country 67910 0
Australia
Phone 67910 0
+61 733620222
Fax 67910 0
Email 67910 0
nick.martin@qimrberghofer.edu.au
Contact person for public queries
Name 67911 0
Kerrie McAloney
Address 67911 0
QIMR Berghofer Medical Research Institute
300 Herston Road, Herston 4006 QLD
Country 67911 0
Australia
Phone 67911 0
+61 7 3362 0111
Fax 67911 0
Email 67911 0
kerrie.mcaloney@qimrberghofer.edu.au
Contact person for scientific queries
Name 67912 0
Michael Breakspear
Address 67912 0
QIMR Berghofer Medical Research Institute
300 Herston Road, Herston 4006 QLD
Country 67912 0
Australia
Phone 67912 0
+61 7 3362 0111
Fax 67912 0
Email 67912 0
Michael.Breakspear@qimrberghofer.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.