Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000923763
Ethics application status
Approved
Date submitted
2/06/2022
Date registered
28/06/2022
Date last updated
9/10/2023
Date data sharing statement initially provided
28/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monash-Alfred Protocol for Assessment of Atypical Parkinsonian Syndromes (MAP-APS)
Scientific title
Monash-Alfred Protocol for Assessment of Atypical Parkinsonian Syndromes (MAP-APS)
Secondary ID [1] 307278 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Progressive supranuclear palsy 326534 0
Multiple Systems Atrophy 326535 0
Corticobasal Syndrome 326536 0
Condition category
Condition code
Neurological 323799 323799 0 0
Other neurological disorders
Neurological 323800 323800 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
The Monash-Alfred Protocol for Assessment of Atypical Parkinsonsian Syndromes (MAP-APS) is a single-site longitudinal registry of patients with APS.

Participants will undergo clinico-demographic and biosampling procedures at entry and periodically to aggregate a database.

Assessments include social and demographic data, medical and medication history. Disease specific neurological assessments using validated rating scales including the Movement Disorders Society - Unified Parkinson's Disease Rating Scale, the Progressive Supranuclear Palsy Rating Scale, Unified Multiple Systems Atrophy Rating Scale. General measures of function and disability include Hoehn and Yahr stage and Modified Rankin Scale. Cognitive screening assessment with the Montreal Cognitive Assessment, Frontal Assessment Battery and categorical fluency. Impact of disease and psychological assessments via validated patient reported outcomes including Neuro-QoL subscales and EQ-5D-5L.
Biological samples include Magnetic Resonance Imaging of the brain and blood samples (4x10mL tubes in total).

Eligible participants will be assessed at recruitment and then annually for up to 3 years; individuals within 5 years of index symptom onset will also undergo a once-off 6-month assessment.
Intervention code [1] 323713 0
Not applicable
Comparator / control treatment
No control group as registry design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331569 0
Create a databank including phenotyping clinical data and biological samples (MRI, blood and cerebrospinal fluid) from individuals with an atypical parkinsonian disorder.
Timepoint [1] 331569 0
Samples will be collected from June 2022 ongoing indefinitely
Secondary outcome [1] 410325 0
Implement the protocol at a single-site to establish the viability and utility of populating a clinical and biological databank of APS patients with minimal resource allocation.
Timepoint [1] 410325 0
Samples will be collected from June 2022, ongoing indefinitely

Eligibility
Key inclusion criteria
All participants must have an eligible diagnosis by a consultant Neurologist with subspeciality expertise in Movement Disorders.
Eligible diagnoses include: Progressive Supranuclear Palsy (PSP, Multiple Systems Atrophy (MSA), Corticobasal Syndrome (CBS)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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
Actual
14/06/2022
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
27
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22540 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 37717 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 311575 0
Hospital
Name [1] 311575 0
Alfred Health, Dept. of Neuroscience/Van Cleef Roet centre for nervous diseases
Country [1] 311575 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health, Neurosciences department
Address
55 Commercial Rd, Melbourne, 3004, VIC
Country
Australia
Secondary sponsor category [1] 312994 0
None
Name [1] 312994 0
Address [1] 312994 0
Country [1] 312994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311022 0
Alfred Ethics Committee
Ethics committee address [1] 311022 0
55 Commercial Rd, Melbourne, 3004, VIC
Ethics committee country [1] 311022 0
Australia
Date submitted for ethics approval [1] 311022 0
Approval date [1] 311022 0
01/11/2019
Ethics approval number [1] 311022 0
157/19

Summary
Brief summary
The MAP-APS registry has been established to assess the feasability and utility of populating a standardised longitudinal dataset on participants with atypical parkinsonsian syndromes at a single site. The protocol has been devised to acquire enough clinical-biological data to perform deep clinical phenotyping while maintaining brevity and minimising allocation of resources and burden on participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119730 0
Prof Terrence O'Brien
Address 119730 0
Alfred Health, 55 Commercial Road, Melbourne, 3004, VIC
Country 119730 0
Australia
Phone 119730 0
+61 418370566
Fax 119730 0
Email 119730 0
t.obrien@alfred.org.au
Contact person for public queries
Name 119731 0
Dr Marian Todaro (ANB Manager)
Address 119731 0
Alfred Health, 55 Commercial Road, Melbourne, 3004, VIC
Country 119731 0
Australia
Phone 119731 0
+61 3 9903 0857
Fax 119731 0
Email 119731 0
anb@alfred.org.au
Contact person for scientific queries
Name 119732 0
Dr Marian Todaro (ANB Manager)
Address 119732 0
Alfred Health, 55 Commercial Road, Melbourne, 3004, VIC
Country 119732 0
Australia
Phone 119732 0
+61 3 9903 0857
Fax 119732 0
Email 119732 0
anb@alfred.org.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
SourceTitleYear of PublicationDOI
EmbaseMonash-Alfred protocol for assessment of atypical parkinsonian syndromes (MAP-APS).2024https://dx.doi.org/10.1136/bmjno-2023-000553
N.B. These documents automatically identified may not have been verified by the study sponsor.