PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK
NCT ID: NCT02778607
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
900 participants
OBSERVATIONAL
2014-10-31
2023-07-31
Brief Summary
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Detailed Description
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PSP and CBD are characterized by tau-pathology and MSA by alpha-synuclein pathology. A great deal of pre-clinical work has been carried out on tau and alpha-synuclein disease models, yet there are no disease modifying agents for these conditions. There are a number of potential therapeutic compounds in development and in order to improve the likelihood of their success, there is a pressing need to increase the number of early case patients recruited into these new treatment trails. Thus, better methods for improved accuracy of early diagnosis and for tracking progression need to be developed. This can be achieved through:
1. a detailed study of the change in patients' clinical state over time;
2. studying "biomarkers" such as blood, skin, spinal fluid and brain MRI.
The investigators will recruit patients with PSP, CBD and MSA who are referred to specialist clinics for assessment and treatment. An additional group of Atypical parkinsonian syndrome (APS) cases who do not meet criteria for Parkinson's disease or other defined conditions, but are considered by the investigator group to be allied syndromes or at risk states will also be invited to participate in the study. People unaffected by neurological disease will be invited to participate on a one-off occasion.
Being involved in the PROSPECT-M-UK longitudinal study will involve attending a research assessment on 5 occasions over 3 years in our natural history cohort, and for 2 occasions over 2 years for our longitudinal cohort. Study procedures consist of: having a neurological examination; completing questionnaires to provide details of clinical history, self/carer reported functional scales and quality of life; neuropsychology assessment; eye movement exam; donating blood and skin samples; some patients will be invited to have a lumbar puncture for spinal fluid collection and have a brain MRI scan on two occasions (at baseline and after 1 year follow-up). Patients can also agree to be contacted by phone or at a clinic appointment for remote monitoring of symptoms after face to face visits have completed.
In addition, a cross-sectional cohort will be established, to enable participation of patients who cannot travel to a study centre. This will involve donating blood samples,returning study questionnaires, and being monitored remotely. A CBD European registry will also be created which will involve a structured neurological assessment, a medical notes review and blood sample donation.
The primary outcome for the study is duration of disease, with the aim to improve methods for early diagnosis and tracking disease progression. Importantly, the study will link together centres and researchers from across Europe to establish the infrastructure and create a trial ready cohort for future therapeutic study into PSP/CBD/MSA.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Progressive Supranuclear Palsy
Patients with a current clinical diagnosis of Progressive Supranuclear Palsy (PSP)
No interventions assigned to this group
Multiple System Atrophy
Patients with current clinical diagnosis of Multiple System Atrophy (MSA).
No interventions assigned to this group
Atypical Parkinsonian Syndrome
Atypical Parkinsonian Syndrome (APS) patients who do not fulfil existing criteria for PSP/CBD/MSA, but may represent variant clinical syndromes related to tau pathology including pure akinesia with gait freezing (PAGF), PSP-parkinsonism, overlap syndromes and atypical parkinsonian disorders not meeting clinical diagnostic criteria at entry
No interventions assigned to this group
Controls
Participants unaffected by neurological or psychiatric disease
No interventions assigned to this group
Corticobasal Degeneration
Patients with a current clinical diagnosis of Corticobasal Degeneration (CBD)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 2\. Fulfills clinical criteria (PSP, MSA, CBD/CBS) or clinically defined allied disorders (at-risk states or intermediate disorders, as above) or a healthy control participant recruited from local volunteer databases or next of kin where they have expressed a wish to participate.
* 3\. Participant is 18 years old or older.
* 4\. Participant has an identified informant.
Exclusion Criteria
* 2\. Participant is pregnant.
18 Years
ALL
Yes
Sponsors
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University of Cambridge
OTHER
University of Oxford
OTHER
University of Manchester
OTHER
Newcastle University
OTHER
University of Sussex
OTHER
Royal Gwent Hospital
UNKNOWN
University College, London
OTHER
Responsible Party
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Principal Investigators
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Huw Morris, PhD, FRCP
Role: PRINCIPAL_INVESTIGATOR
University College, London
Locations
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University College London Hospitals
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14/0371
Identifier Type: -
Identifier Source: org_study_id
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