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Longitudinal study of early Alzheimer's disease using genetics, brain imaging and behavioural assessments.

Prospective Imaging Study of Ageing: Genes, Brain and Behaviour

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001581459
Acronym
PISA
Enrollment
265
Registered
2016-11-16
Start date
2017-06-01
Completion date
2021-03-10
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The PISA project seeks to reduce Australia’s future dementia burden by elucidating methods to identify those Australians at the very early stages of dementia. This project aims to achieve this goal by monitoring participants’ physical, cognitive and neurobiological ageing in a cross-sectional, longitudinal design. The tests used in this study include cognitive testing, MRI examinations, PET imaging examinations and blood sample collection. Participants will undergo testing once every two years, over a five year period. Participants will also be given a wearable smart sensing device that will record personalised health data in day to day life, over the course of the study.

Interventions

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 moveme

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.

Sponsors

QIMR Berghofer Medical Research Institute
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026