PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK

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Brief Title

PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK

Official Title

PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK

Brief Summary

      Progressive Supranuclear Palsy (PSP), Cortico-Basal Degeneration (CBD) and Multiple System
      Atrophy (MSA) are degenerative brain conditions for which there are currently no curative
      treatments. To aid the development of new treatment trials, there is a pressing need to
      develop better methods for diagnosing these conditions early, and to track disease
      progression. The PROSPECT-M-UK study will collect standardised clinical data over time.
      Patients will also have the option to have a brain MRI scan, eye movement exam and donate
      blood, skin and spinal fluid samples, with the aim to identify "biomarkers" that can improve
      the accuracy of early diagnosis and track the natural time course of disease. Control
      participants and those not meeting criteria for Parkinson's disease or other defined
      conditions but are considered by the investigator group to be allied syndromes or at risk
      states (atypical parkinsonian syndromes), will also be examined. Patients can also
      participate via the CBD European registry or in a one-off study assessment through the
      cross-sectional study, which involves completing questionnaires and a blood sample donation.
    

Detailed Description

      There are a group of neurodegenerative disorders which are often initially diagnosed to be
      Parkinson's disease (PD), but which are biologically and clinically distinct, and follow a
      malignant disease course. The three most common conditions are PSP, CBD and MSA. These
      conditions have a median survival of approximately 6-7 years and unlike PD, do not respond
      well to dopamine replacement therapy.

      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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Survival status after 5 years of clinical follow-up

Secondary Outcome

 Annual change in degree of disability in PSP, CBD and APS cases as determined by the PSP rating scale

Condition

Progressive Supranuclear Palsy (PSP)


Study Arms / Comparison Groups

 Progressive Supranuclear Palsy
Description:  Patients with a current clinical diagnosis of Progressive Supranuclear Palsy (PSP)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

900

Start Date

October 2014

Completion Date

July 2023

Primary Completion Date

July 2023

Eligibility Criteria

        Inclusion Criteria:

          -  1. Written informed consent obtained prior to any study-related procedures. A
             consultee process will be used where participants lack the mental capacity for
             consent, either due to cognitive or communication deficits.

          -  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:

          -  1. Participant has another significant medical or psychiatric illness that would
             interfere in completing assessments

          -  2. Participant is pregnant.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Huw Morris, PhD, FRCP, 020 310 87462, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02778607

Organization ID

14/0371


Responsible Party

Sponsor

Study Sponsor

University College, London

Collaborators

 University of Cambridge

Study Sponsor

Huw Morris, PhD, FRCP, Principal Investigator, University College, London


Verification Date

October 2020