Preparing for Prevention of Huntington’s Disease (PREVENT-HD)

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Brief Title

Preparing for Prevention of Huntington's Disease (PREVENT-HD)

Official Title

Preparing for Prevention of Huntington's Disease (PREVENT-HD)

Brief Summary

      This is a prospective investigation which aims to address key challenges to the design of
      clinical trials to prevent the onset of Huntington's disease (HD). The project will provide
      necessary psychometric data for clinical outcome assessments (COAs) and biomarkers (BMs) in
      the cerebral spinal fluid (CSF) to address questions of central importance to the success of
      these measures for premanifest clinical trials. Of the 258 participants: 52 will be low risk
      of motor diagnosis, 102 high risk of motor diagnosis, 52 with diagnosed HD (stages I or II),
      and 52 healthy controls. Participants can expect to be on study for up to 2 years.
    

Detailed Description

      This is a prospective investigation which aims to address key challenges to the design of
      clinical trials to prevent the onset of Huntington's disease (HD). The project will provide
      necessary psychometric data for clinical outcome assessments (COAs) and biomarkers (BMs) in
      the cerebral spinal fluid (CSF) to address questions of central importance to the success of
      this measure for premanifest clinical trials such as: (1) How reliable the measure is in the
      same person when repeated over time; (2) how reliable the measure is in the same person when
      analyzed by two different labs/sites; (3) how well the measure reflects disease symptoms; (4)
      how well the measure predicts meaningful disease outcomes; (5) how well the measure tracks
      disease progression or severity; and (6) how many research subjects are required to test that
      an intervention is delaying/slowing the onset of HD? Answers to these questions will better
      position the field to more effectively test new interventions to prevent HD such as gene
      therapies and new drugs.

      Neurocognitive, motor and behavioral data, blood, CSF, and genetic samples, and MRI measures
      will be collected from 258 participants at baseline. Of the 258 participants: 52 will be low
      risk of motor diagnosis, 102 high risk of motor diagnosis, 52 with diagnosed HD (stages I or
      II), and 52 healthy controls. Neurocognitive and behavioral data, blood and CSF samples, and
      MRI will be repeated 2 years (18-24 months) after the baseline visit. Remote assessments of
      clinical outcome measures (neurocognitive, motor and behavioral data) will be conducted 1
      year (9-12 months) following baseline to determine the feasibility of at-home HD assessment
      for research.

      Specific Study Aims and Methods

      Aim 1: To evaluate Clinical Outcome Assessments (COAs) currently being used in premanifest
      HD. In accordance with the FDA, all types of COAs (a) Clinician-reported; (b)
      Observer-reported; (c) Patient-reported; and (d) Performance-based outcomes will be evaluated
      as appropriate for each phenotypic domain (motor, cognitive, psychiatric/behavioral,
      functional activity, quality of life). Specific outcomes of this aim will follow those
      recommended by the FDA including:

        -  a) Cross-sectional evaluation (critical for sample selection) of currently-used COA
           instruments according to the following recommended criteria: mode of administration;
           format and scoring criteria; content validity; internal consistency reliability;
           test-retest reliability; floor and ceiling effects; construct validity; convergent
           validity; and strength of each COA expressed in terms of effect sizes.

        -  b) Longitudinal evaluation (critical for endpoint selection and responsiveness) of each
           COA to detect change using effect sizes across the premanifest and early HD disease
           continuum with documentation of the responder definition(s) of construct validity.

        -  c) Identification and documentation of the context of use (COU) and concept of interest
           (COI) for clinical trials in premanifest HD to position available COAs within a
           preliminary conceptual model.

      Aim 2: To assess the psychometric properties of various biomarkers obtained from cerebral
      spinal fluid when compared between groups (premanifest HD, HD, NC) and over time (baseline
      and 2 years). Specific outcomes of this aim will include:

        -  a) CSF mHTT collected at baseline and 2 years in 100 premanifest HD, 25 diagnosed HD,
           and 25 healthy controls (HC) will be analyzed (blind to gene status) by two independent
           labs. Safety, feasibility, cost efficiency, and inter-site reliability will be obtained.

        -  b) Validity of CSF mutant huntingtin (mHTT) will be examined in HD groups for
           association with cross-sectional and longitudinal (a) phenotypic severity and decline
           using measures of the primary triad of clinical manifestation and progression (motor,
           cognitive, psychiatric/behavioral); (b) meaningful clinical outcome measures such as
           diagnosis in premanifest subjects and patient-reported outcomes, functional capacity and
           disability in all HD patients; and (c) available disease burden measures calculated as
           the product of Cytosine-Adenine-Guanine (CAG) repeat length and current age (considered
           a reflection of genetic toxicity by time survived; AKA disease burden). The
           investigators hypothesize that the candidate biomarkers will show appropriate
           association reflecting concurrent and predictive validity (types of criterion-related
           validity) with the most widespread "benchmarks" of HD phenotype, the Unified HD Rating
           Scale in diagnosed and advanced prodromal HD. Data from this Aim will immediately inform
           the interpretation of ongoing clinical trials that show biomarker levels in "some", but
           not "all", premanifest. Although it is unknown whether the biomarkers will demonstrate
           any predictive validity or concurrent validity for the entire premanifest HD group, data
           will immediately be useful to develop an evidence threshold for when in the premanifest
           HD prodrome, the biomarker will be detectable and tracked over time. The evidence
           threshold is immediately useful to the design of disease modifying trials in HD,
           particularly when the paramount goal is to prevent diagnosis, or manifestation.

        -  c) Biological criterion-related validity for biomarkers will be examined in HD groups
           for association with (a) microglial biomarkers; (b) inflammatory biomarkers; (c)
           neuronal death biomarkers; and (d) mHTT HD-specific protein. The investigators
           hypothesize that mHTT will show detection at the earliest point in the prodrome,
           followed by microglial markers, then inflammatory markers and, finally, neuron death
           markers in diagnosed HD.
    


Study Type

Observational


Primary Outcome

Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Level

Secondary Outcome

 CANTAB composite score

Condition

Huntington Disease

Intervention

Clinical Assessments

Study Arms / Comparison Groups

 Low Risk of Motor Diagnosis
Description:  

Publications

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

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

258

Start Date

September 13, 2021

Completion Date

February 2026

Primary Completion Date

February 2026

Eligibility Criteria

        Inclusion Criteria for HD Participants:

          -  Estimated at low or high probability of motor diagnosis based the multivariate risk
             score (MRS)

          -  Willing to commit to two in-person assessment visits (baseline and 2 year follow-up)
             and one remote assessment (1 year follow-up)

          -  No active comorbidities (i.e. receiving stable treatment)

          -  All medications will be allowed although the protocol will mandate documentation of
             medications and analyses will particularly assess potential impact of medications on
             outcomes (i.e., sedation of abnormal movements)

          -  CAG results must be 36 and above as measured in genetic tests already completed

        Inclusion Criteria for Healthy Controls (HC):

          -  Willing to commit to two in-person assessment visits (baseline and 2 year follow-up)
             and one remote assessment (1 year follow-up)

          -  In generally good health

          -  IQ > 70

          -  Able to undergo an MRI scan

        Exclusion Criteria (for all Participants):

          -  Evidence of unstable medical or psychiatric illness (including substance abuse)

          -  History of severe learning disability, mental retardation, or other central nervous
             system (CNS) disease or event (e.g., seizures, head trauma, additional neurological
             diagnoses)

          -  Treatment with phenothiazine-derivative antiemetic medications such as
             prochlorperazine, metoclopramide, promethazine and Inapsine greater than 3 times per
             month

          -  History of serious alcohol or drug abuse within the past year

          -  Unable (determined by patient's prescribing doctor) to not take tryptophan, leucine,
             niacin or niacinamide-containing dietary supplements, anti-inflammatory medications,
             anti-coagulants (such as warfarin and heparin) or anti-platelets (such as aspirin) in
             the past 14 days to assure safety during lumbar puncture

          -  Unable to fast (no food or drink, only water) overnight before the lumbar puncture
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jane S Paulsen, PhD, (608) 265-4242, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04818060

Organization ID

2020-1175

Secondary IDs

A535100

Responsible Party

Sponsor

Study Sponsor

University of Wisconsin, Madison

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Jane S Paulsen, PhD, Principal Investigator, University of Wisconsin, Madison


Verification Date

September 2021