Challenges assessing clinical endpoints in early Huntington disease
Identifieur interne : 002C52 ( Ncbi/Checkpoint ); précédent : 002C51; suivant : 002C53Challenges assessing clinical endpoints in early Huntington disease
Auteurs : Jane S. Paulsen [États-Unis] ; Chiachi Wang [États-Unis] ; Kevin Duff [États-Unis] ; Roger Barker [Royaume-Uni] ; Martha Nance [États-Unis] ; Leigh Beglinger [États-Unis] ; David Moser [États-Unis] ; Janet K. Williams [États-Unis] ; Sheila Simpson [Royaume-Uni] ; Douglas Langbehn [États-Unis] ; Daniel P. Van Kammen [États-Unis]Source :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2010.
English descriptors
- KwdEn :
- MESH :
- diagnosis : Huntington Disease.
- genetics : Huntington Disease.
- methods : Endpoint Determination.
- therapy : Huntington Disease.
- Adolescent, Adult, Aged, Clinical Trials as Topic, Female, Genetic Testing, Humans, Longitudinal Studies, Male, Middle Aged.
Abstract
The primary aim of this study was to evaluate the current accepted standard clinical endpoint for the earliest-studied HD participants likely to be recruited into clinical trials. Since the advent of genetic testing for HD, it is possible to identify gene carriers prior to the diagnosis of disease, which opens up the possibility of clinical trials of disease-modifying treatments in clinically asymptomatic persons. Current accepted standard clinical endpoints were examined as part of a multi-national, 32-site, longitudinal, observational study of 786 research participants currently in the HD prodrome (gene-positive but not clinically diagnosed). Clinical signs and symptoms were used to prospectively predict functional loss as assessed by current accepted standard endpoints over 8 years of follow up. Functional capacity measures were not sensitive for HD in the prodrome; over 88% scored at ceiling. Prospective evaluation revealed that the first functional loss was in their accustomed work. In a survival analysis, motor, cognitive, and psychiatric measures were all predictors of job change. To our knowledge, this is the first prospective study ever conducted on the emergence of functional loss secondary to brain disease. We conclude that future clinical trials designed for very early disease will require the development of new and more sensitive measures of real-life function.
Url:
DOI: 10.1002/mds.23337
PubMed: 20623772
PubMed Central: 2978744
Affiliations:
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<term>Adult</term>
<term>Aged</term>
<term>Clinical Trials as Topic</term>
<term>Endpoint Determination (methods)</term>
<term>Female</term>
<term>Genetic Testing</term>
<term>Humans</term>
<term>Huntington Disease (diagnosis)</term>
<term>Huntington Disease (genetics)</term>
<term>Huntington Disease (therapy)</term>
<term>Longitudinal Studies</term>
<term>Male</term>
<term>Middle Aged</term>
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<keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Huntington Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Endpoint Determination</term>
</keywords>
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</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Clinical Trials as Topic</term>
<term>Female</term>
<term>Genetic Testing</term>
<term>Humans</term>
<term>Longitudinal Studies</term>
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<front><div type="abstract" xml:lang="en"><p id="P1">The primary aim of this study was to evaluate the current accepted standard clinical endpoint for the earliest-studied HD participants likely to be recruited into clinical trials. Since the advent of genetic testing for HD, it is possible to identify gene carriers prior to the diagnosis of disease, which opens up the possibility of clinical trials of disease-modifying treatments in clinically asymptomatic persons. Current accepted standard clinical endpoints were examined as part of a multi-national, 32-site, longitudinal, observational study of 786 research participants currently in the HD prodrome (gene-positive but not clinically diagnosed). Clinical signs and symptoms were used to prospectively predict functional loss as assessed by current accepted standard endpoints over 8 years of follow up. Functional capacity measures were not sensitive for HD in the prodrome; over 88% scored at ceiling. Prospective evaluation revealed that the first functional loss was in their accustomed work. In a survival analysis, motor, cognitive, and psychiatric measures were all predictors of job change. To our knowledge, this is the first prospective study ever conducted on the emergence of functional loss secondary to brain disease. We conclude that future clinical trials designed for very early disease will require the development of new and more sensitive measures of real-life function.</p>
</div>
</front>
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<name sortKey="Nance, Martha" sort="Nance, Martha" uniqKey="Nance M" first="Martha" last="Nance">Martha Nance</name>
<name sortKey="Paulsen, Jane S" sort="Paulsen, Jane S" uniqKey="Paulsen J" first="Jane S." last="Paulsen">Jane S. Paulsen</name>
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<name sortKey="Williams, Janet K" sort="Williams, Janet K" uniqKey="Williams J" first="Janet K." last="Williams">Janet K. Williams</name>
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