Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000212257
Ethics application status
Approved
Date submitted
25/01/2018
Date registered
9/02/2018
Date last updated
22/12/2021
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 293861 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia with Lewy bodies 306323 0
Alzheimer's disease 318572 0
Parkinson's disease dementia 318573 0
Condition category
Condition code
Neurological 305407 305407 0 0
Dementias

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 300122 0
Not applicable
Comparator / control treatment
20 participants with Alzheimer's disease (AD) will undergo clinical and cognitive assessments, blood test, brain MRI scan, optional amyloid, tau brain PET imaging, and optional cerebrospinal fluid collection at baseline only. The total observational period for AD participants will be 3 months.

20 Healthy control participants will undergo clinical and cognitive assessments, blood test, brain MRI scan, optional amyloid brain PET imaging, and optional cerebrospinal fluid collection at baseline only. The total observational period for healthy control participants will be 3 months.
Control group
Active

Outcomes
Primary outcome [1] 304543 0
To assess the rates of change in clinical, cognitive, neuropsychiatric symptoms and function and how this relates to disease biomarkers (amyloid, tau and cerebrovascular disease) in participants with dementia with Lewy bodies over 18 months. This is a composite primary outcome (ie looking at all factors that may impact the course of the disease process).
Cognitive: sMMSE, ACE III, MoCA, CDR, NPI, computerised attentional tests.
Function and Neuropsychiatric Symptoms: Neuropsychiatric Inventory (NPI); GDS, BADL and ADCS-ADL assessments of activities of daily living.
Quality of Life measures: DEMQOL and EQ-5D.
Imaging: Brain MRI, brain PET scans (amyloid, tau and VMAT2).
Blood and cerebrospinal fluid biomarkers (exploratory outcomes) - APOE status and inflammatory markers will be assessed in blood. Tau, beta amyloid and a-synuclein will be assessed in cerebrospinal fluid.
Timepoint [1] 304543 0
Participants will be assessed in-person every 12 months for 3 years and contacted by telephone every 6 months. Halfway point of 18 months is the primary timepoint.
Baseline, 12 months, 24 months, 36 months: CDR, sMMSE, ACE III, MoCA, computerised attentional test, NPI, GDS, BADL, ADCS-ADL, UPDRS III, DEMQOL,EQ-5D, Zarit burden. Brain MRI, blood test, optional brain PET scans (amyloid, tau and VMAT2) and optional cerebrospinal fluid samples at baseline..
6 months, 18 months, 30 months - check-in phone call
Secondary outcome [1] 342775 0
To assess the rates of change in clinical, cognitive, neuropsychiatric symptoms and function and how this relates to disease biomarkers (amyloid and cerebrovascular disease) in participants with dementia with Lewy bodies over a 3 year period. This is a composite secondary outcome. Cognitive: sMMSE, ACE III, MoCA, CDR, NPI, computerised attentional tests. Function and Neuropsychiatric Symptoms: Neuropsychiatric Inventory (NPI); GDS, BADL and DAD assessments of activities of daily living. Quality of Life measures: DEMQOL and EQ-5D. Imaging: Brain MRI, and optional brain amyloid PET scans.
Timepoint [1] 342775 0
The secondary timepoint will be 36 months (from study enrolment) for all measures: sMMSE, computerised attentional test, GDS, NPI, BADL. CDR, ACE III, MoCA, UPDRS III, DEMQOL, EQ-5D, Zarit burden. Brain MRI. Optional follow up amyloid brain PET scan.

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/03/2018
Actual
13/03/2018
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
160
Accrual to date
54
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 18639 0
3052 - Parkville
Recruitment postcode(s) [2] 30955 0
6000 - Perth
Recruitment postcode(s) [3] 30956 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 298481 0
Charities/Societies/Foundations
Name [1] 298481 0
Yulgilbar Foundation
Country [1] 298481 0
Australia
Primary sponsor type
Other
Name
Walter and Eliza Hall Institute of Medical Research
Address
1G Royal Parade
Parkville Victoria 3050
Country
Australia
Secondary sponsor category [1] 297625 0
None
Name [1] 297625 0
Address [1] 297625 0
Country [1] 297625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299468 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299468 0
Royal Melbourne Hospital
Level 2
South West
300 Grattan Street
Parkville Victoria
Ethics committee country [1] 299468 0
Australia
Date submitted for ethics approval [1] 299468 0
29/03/2017
Approval date [1] 299468 0
11/09/2017
Ethics approval number [1] 299468 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Healthy volunteers will be in control group only

Contacts
Principal investigator
Name 80506 0
A/Prof Rosie Watson
Address 80506 0
Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville, Victoria 3052
Country 80506 0
Australia
Phone 80506 0
+61 3 9345 2177
Fax 80506 0
Email 80506 0
[email protected]
Contact person for public queries
Name 80507 0
Ms Lesley Vidaurre
Address 80507 0
Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville, Victoria 3052
Country 80507 0
Australia
Phone 80507 0
+61 3 9345 2177
Fax 80507 0
Email 80507 0
[email protected]
Contact person for scientific queries
Name 80508 0
A/Prof Rosie Watson
Address 80508 0
Walter and Eliza Hall Institute of Medical Research, 1G Royal Parade, Parkville, Victoria 3052
Country 80508 0
Australia
Phone 80508 0
+61 3 9345 2177
Fax 80508 0
Email 80508 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
Group analysis data will be available however it has not yet been confirmed if IPD will be available


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.