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The Lewy Body Study - an observational study that will assess the changes that occur in memory and thinking skills and changes that occur in the body of 100 participants with dementia with Lewy bodies over a 3 year period.

A longitudinal cohort study of dementia with Lewy bodies - Unravelling the confounding influences of Alzheimer’s disease and cerebrovascular disease in dementia with Lewy bodies.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000212257
Enrollment
54
Registered
2018-02-09
Start date
2018-03-13
Completion date
2022-06-30
Last updated
2021-12-27

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

Conditions

None listed

Brief summary

Lewy body diseases are a common form of neurodegenerative disorders which includes Parkinson’s disease (PD), Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB). DLB and PDD are both termed Lewy body dementias, with many overlaps clinically and pathologically. Lewy body dementias also share many features with Alzheimer’s disease (AD). Dementia with Lewy bodies is a common form of dementia in older age (approximately 1 in 6 of all dementia cases), However there are very few longitudinal studies that investigate the changes that occur in the brain and in the body of people with DLB. People with DLB have an abnormal accumulation of the protein alpha-synuclein in their brain which may affect memory, thinking, behaviour, mood and movement. Many cases of DLB have multiple changes in brain pathology, such as vascular disease changes, or the accumulation of other proteins, such as amyloid and tau, that are found in Alzheimer’s disease. However it is not known what effect these changes have when there are also Lewy bodies present. In order to understand the disease process and offer potentially effective treatments in the future, these changes need to be investigated. The Lewy Body Study will establish an Australian cohort of 100 individuals diagnosed with DLB and follow them over the course of 3 years to investigate factors which may help to predict disease outcomes, and which may lead to effective treatments being available in the future. As comparison groups, 20 people diagnosed with PDD, 20 people diagnosed with AD and 20 healthy control participants will also be enrolled. So that the rate of disease changes can be monitored DLB participants will undergo clinical and cognitive (memory and thinking) assessments and health related questionnaires, a blood test and brain MRI scans every 12 months; and optional brain PET imaging scans. There is also an opportunity for participants to undergo cerebrospinal fluid collection (optional). DLB is currently widely under-diagnosed. The Lewy Body Study will provide the largest depository of DLB disease related data in Australia that will be made available to approved researchers both nationally and internationally to help further dementia research. We aim to establish whether there are any disease biomarkers (genetic, blood, imaging, cognitive) which may help improve the diagnosis rate of DLB which may in turn improve the treatments and outcomes for those diagnosed with this disease.

Interventions

To determine the rates of change in clinical, cognitive, behavioural and imaging biomarkers: * Participants with dementia with Lewy bodies (DLB) will undergo clinical and cognitive assessments, blood tests and brain MRI scans every 12 months; optional amyloid, tau and dopaminergic brain PET imaging at baseline; and optional cerebrospinal fluid collection at baseline. The total observational period for DLB participants will be 3 years. * Participants with Parkinson's disease dementia (PDD) w

To determine the rates of change in clinical, cognitive, behavioural and imaging biomarkers: * Participants with dementia with Lewy bodies (DLB) will undergo clinical and cognitive assessments, blood tests and brain MRI scans every 12 months; optional amyloid, tau and dopaminergic brain PET imaging at baseline; and optional cerebrospinal fluid collection at baseline. The total observational period for DLB participants will be 3 years. * Participants with Parkinson's disease dementia (PDD) will undergo clinical and cognitive assessments, and blood tests every 12 months; and at baseline only a brain MRI scan, and optional amyloid, tau and dopaminergic brain PET imaging; and optional cerebrospinal fluid collection at baseline. The total observational period for PDD participants will be 3 years.

Sponsors

Walter and Eliza Hall Institute of Medical Research
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

DLB/PDD/AD participants: Fulfills clinical diagnostic criteria for probable dementia with Lewy bodies (DLB) OR Fulfills clinical diagnostic criteria for probable Parkinson's disease dementia (PDD) OR Fulfills clinical diagnostic criteria for probable Alzheimer's disease (AD) AND: Male or female aged 50+ MMSE greater than or equal to 14 no past history of alcohol or drug dependence english as first language or adequate understanding for cognitive testing adequate visual and auditory acuity to perform neuropsychological testing Healthy Volunteers: Male or female aged 50+ MMSE greater than or equal to 27 Absence of severe medical illness No active, clinically significant psychiatric illness No history of drug or alcohol dependence English as first language or adequate understanding for cognitive testing Adequate visual and auditory acuity to perform neuropsychological testing

Exclusion criteria

DLB/PDD/AD participants: alcohol intake greater than 4 standard alcoholic drinks per day no identifiable family carer or other informant Healthy controls: No active, clinically significant psychiatric illness - this can impact on cognition and would not be suitable as a healthy control comparison No severe medical illness that may impede study participation contraindications to MRI (e.g. pacemaker, stents, metal implants)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026