HDClarity

Recruiting

SPONSOR

CHDI Foundation, Inc.

PARTICIPANTS

1200

HDClarity us aiming to collect a high quality Cerebrospinal fluid (CSF) for evaluation of biomarkers and pathways that will enable the development of novel treatments for Huntington’s disease (HD). The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development.

Ages Eligible
for Study:

21 Years to 75 Years

(Adult, Older Adult)

Sexes Eligible
for Study:

All

Accepts Healthy Volunteers:

Yes

All eligible participants:
a) Are 21-75 years of age, inclusive; and
b) Are capable of providing informed consent or have a legal representative authorized to give consent on behalf of the participant; and
c) Are capable of complying with study procedures, including fasting, blood sampling and lumbar puncture; and
d) Are participating in the Enroll-HD study; and
e) Will have had an Enroll-HD visit within two months of the Screening Visit.

For the Healthy Control group, participants eligible are persons who meet the following criteria:
a) Have no known family history of HD; or
b) Have known family history of HD but have been tested for the huntingtin gene CAG expansion and are not at genetic risk for HD (CAG < 36).

For the Early Pre-manifest HD group, participants eligible are persons who meet the following criteria:
a) Do not have clinical diagnostic motor features of HD, defined as Unified Huntington’s Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4; and
b) Have CAG expansion ≥ 40; and c. Have burden of pathology score, computed as (CAG – 35.5) × age, < 250.

For the Late Pre-manifest HD group, participants eligible are persons who meet the following criteria:

  • Do not have clinical diagnostic motor features of HD, defined as Unified Huntington’s Disease Rating Scale (UHDRS) Diagnostic Confidence Score < 4; and
  • Have CAG expansion ≥ 40; and
  • Have burden of pathology score, computed as (CAG – 35.5) x age, ≥ 250.

For Early Manifest HD group, participants eligible are persons who meet the following criteria:

  • Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
  • Have CAG expansion ≥ 40; and
  • Have Stage I or Stage II HD, defined as UHDRS Total Functional Capacity (TFC) scores between 7 and 13 inclusive.

For Moderate Manifest HD group, participants eligible are persons who meet the following criteria: 

  • Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
  • Have CAG expansion ≥ 40; and
  • Have Stage III HD, defined as UHDRS TFC scores between 3 and 6, inclusive.

For Advanced Manifest HD group, participants eligible are persons who meet the following criteria:

  • Have clinical diagnostic motor features of HD, defined as UHDRS Diagnostic Confidence Score = 4; and
  • Have CAG expansion ≥ 40; and
  • Have Stage IV HD, defined as UHDRS TFC scores between 0 and 2, inclusive.
  1.  

For all groups, participants are ineligible if they meet any of the following exclusion criteria:

  1. Use of investigational drugs or participation in a clinical drug trial within 30 days prior to Sampling Visit; or
  2. Current intoxication, drug or alcohol abuse or dependence; or
  3. If using any medications or nutraceuticals, the use of inappropriate (e.g., non prescribed) or unstable dose within 30 days prior to Sampling Visit; or
  4. Significant medical, neurological or psychiatric co-morbidity likely, in the judgment of the Site Principal Investigator, to impair participant’s ability to complete study procedures, or likely to reduce the utility of the samples and data for the study of HD; or
  5. Needle phobia, frequent headache, significant lower spinal deformity or major surgery; or
  6. Antiplatelet or anticoagulant therapy within the 14 days prior to Sampling Visit, including but not limited to: aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban; or
  7. Clotting or bruising disorder; or
  8. Screening blood test results more than 10% outside the lab’s normal range for the following: white cell count, neutrophil count, lymphocyte count, hemoglobin (Hb), platelets, prothrombin time (PT) and activated partial thromboplastin time (APTT), or any combination of blood test results that the Site Principal Investigator deems to be of clinical significance; or
  9. Screening blood test results for C-reactive protein (CRP)>2× upper limit of normal; or
  10. Predictable non-compliance as assessed by Site Principal Investigator; or
  11. Inability or unwillingness to undertake any of the study procedures; or
  12. Exclusion during history or physical examination, final decision to be made by the Site Principal Investigator; including but not limited to:

i. any reason to suspect abnormal bleeding tendency, e.g. easy bruising, petechial rash; or

ii. any reason to suspect new focal neurological lesion, e.g. new headache, optic disc swelling, asymmetric focal long tract signs; or

iii. any other reason that, in the clinical judgment of the Site Principal Investigator, it is felt that lumbar puncture performed per this protocol and associated manuals is unsafe without brain imaging.

m. Serious Adverse Event (SAE) related to study procedures during or following any previous HDClarity Sampling Visit (if applicable), or SAE related to any other lumbar puncture in the previous 12 months.

LOCATIONS

COUNTRIES

GERMANY

TRIAL SITE:
George Huntington Institute

Address: Münster, Germany, 48149.

CONTACT
Svenja Aufenberg
Tel.: +49-251-788-788-0
svenja.aufenberg@ghi-muenster.de

Principal Investigator: Ralf Reilmann 

Recruiting

TRIAL SITE: 
University Hospital Ulm

Address: Ulm, Baden-Württemberg, Germany, 89081

CONTACT
Hela Jerbi
Tel.: +49 731-500-63080
hela.jerbi@uniklinik-ulm.de

Principal Investigator: Jan Lewerenz, MD   

Recruiting

TRIAL SITE:
St Josef And Elisabeth Hospital

Address: Bochum, Germany, 44791.

CONTACT
Barbara Kaminski
b.kaminski@klinikum-bochum.de

Principal Investigator: Carsten Saft  

Recruiting

TRIAL SITE:
University Hospital of Erlangen

Address: Erlangen, Germany, 91054

CONTACT
Pia-Marie Pryssok
Tel.: 09131-85-44751
pia-marie.pryssok@uk-erlangen.de

Principal Investigator: Winkler Jurgen

Recruiting

TRIAL SITE: 
Dresden University

Address:Dresden, Saxony, Germany, 01307

CONTACT
Simone Koegler
Tel.:  351- 458 2524
simone.koegler@uniklinikum-dresden.de

Principal Investigator: Bjoern Falkerburger, MD

Recruiting

ITALY

TRIAL SITE:
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Address: Milan, Italy, 20133

CONTACT
Anna Castaldo
Tel.: (+)39 0223942519
anna.castaldo@istituto-besta.it

Principal Investigator: Caterina Mariotti, MD

Recruiting

TRIAL SITE: 
Lega Italiana Ricera Huntington

Address: Rome, Italy, 00185

CONTACT
Consuelo Ceccarelli
consuelo.ceccarelli@lirh.it

Principal Investigator: Ferdinando Squitieri, MD

Recruiting

POLAND

TRIAL SITE:
Instytut Psychiatrii i Neurologii w Warszawie (IPIN)

Address: Jana III Sobieskiego 9, 02-957 Warszawa, Polonia

CONTACT
Malgorzata Rowinska
m.dusza.rowinska@gmail.com 

Principal Investigator:
Grzegorz Witkowski
9greg@wp.pl

Recruiting

SPAIN

TRIAL SITE:
Hospital de Sant Pau

Address: Barcelona, Spain, 08041

CONTACT
Cristina Barrionuevo
Tel.: +34 649 14 23 60
CIzquierdo@santpau.cat  

Principal Investigator: Jamie Kulisevsky, MD, PhD

Recruiting

TRIAL SITE:
Hospital Universitario Ramon y Cajal

Address: M-607, 9, 100, 28034 Madrid, Spain

CONTACT
Mónica Aguilar
monicaaguilar.hrc@gmail.com

Principal Investigator:
Jose Lopez-Sendon
joselopezsendon@hotmail.com

Recruiting

TRIAL SITE:
Biocruces Bizkaia Health Research Institute

Address: Cruces Plaza, 48903 Barakaldo, Bizkaia

CONTACT
Marian Ángeles Acera Gil
M.ANGELES.ACERAGIL@osakidetza.eus

Principal Investigator:
Tamara Fernandez Valle
tamara.fernandezvalle@osakidetza.eus

Recruiting

UNITED KINGDOM

TRIAL SITE:
Royal Devon & Exeter NHS Foundation Trust

Address: Exeter, Devon, United Kingdom, EX2 5DW

CONTACT
Robert Wells
Tel.: 01392408181
Robert.wells2@nhs.net

Principal Investigator: Tim Harrower, MBBS

Recruiting

TRIAL SITE: 
Glasgow Clinical Research Facility

Address: Glasgow, Scotland, United Kingdom, G51 4TF

CONTACT
Helen Bannister
Tel.: 0141 232 7600
helen.bannister@ggc.scot.nhs.uk

Principal Investigator: Matthew Sheridan, MBBS

Recruiting

TRIAL SITE:
Birmingham Huntingtons Disease Clinic

Address: Birmingham, West Midlands, United Kingdom, B15 2 FG

CONTACT
Jennifer De Souza
Tel.: 0121 301 2363    jennifer.desouza@bsmhft.nhs.uk

Principal Investigator: Hugh Rickards, MB, ChB, MSc, FRCPsych, MD

Recruiting

TRIAL SITE:
Cambridge University Hospitals NHS Foundation Trust

Address: Cambridge, United Kingdom, CB2 0PY

CONTACT
Katie Andresen   
Tel.: 01223 331141    kera2@cam.ac.uk

Principal Investigator: Roger Barker 

Recruiting

TRIAL SITE: 
Fife Health Board – Whyteman’s Brae Hospital

Address: Kirkcaldy, United Kingdom, KY1 2ND

CONTACT
Fleur Davey   
Tel.: 01383 623623    fleurdavey@nhs.net

Principal Investigator: Robert Thompson, MBBS 

Recruiting

TRIAL SITE:
Leeds Teaching Hospital Trust

Address: Leeds, United Kingdom, LS7 4SA

CONTACT
Callum Schofield   
Tel.: 0113 39 24679    callum.schofield@nhs.net

Principal Investigator: Jeremy Cosgrove, MBBS

Recruiting

TRIAL SITE:
The Walton Centre NHS Foundation Trust

Address: Liverpool, United Kingdom, L9 7LJ

CONTACT
Andrea Clyne, BSc MSc
andrea.clyne@thewaltoncentre.nhs.uk

Principal Investigator: Rhys Davies, MA BM BCh PhD FRCP   

Recruiting

TRIAL SITE: 
University College London Hospitals NHS Foundation Trust

Address: London, United Kingdom, NW1 2P

CONTACT
Fiona Kinsella
Tel.: 0203 108 2638 fiona.kinsella.19@ucl.ac.uk

Alexander Lowe
alexander.lowe.16@ucl.ac.uk

Principal Investigator: Edward Wild, MD, PhD

Recruiting

TRIAL SITE:
Oxford University Hospitals NHS Foundation Trust

Address: Oxford, United Kingdom, OX3 9DU

CONTACT
Zara Skitt   
Tel.: 01865 234309  zara.skitt@ouh.nhs.uk

Principal Investigator: Richard Armstrong, MA, PhD, BMBCh, MRCP 

Recruiting

TRIAL SITE:
University Hospitals Plymouth NHS Trust

Address: Plymouth, United Kingdom, PL6 5FP

CONTACT
Abigail Patrick
Tel.: 01752 439636   abigail.patrick1@nhs.net

Principal Investigator: Daniel Lashley, MBBS  

Recruiting

TRIAL SITE:
North Bristol NHS Trust

Address: Bristol, United Kingdom, BS10 5NB

CONTACT
Catherine Watkins
catherine.watkins@nbt.nhs.uk

Principal Investigator: Elizabeth Coulthard, MBBS

Recruiting

TRIAL SITE:
Cardiff University

Address: Cardiff, United Kingdom, CF24 4HQ

CONTACT
Alison Johnson  
Tel.: 02920746394   alison.johnson@wales.nhs.uk

Principal Investigator: Anne Rosser, MD

Recruiting

TRIAL SITE:
St George’s University Of London

Address:London, United Kingdom, SW17 0RE

CONTACT
Sally Goff
Tel.: 0208 725 5375 sally.goff@nihr.ac.uk

Principal Investigator: Nayana Lahiri    

Recruiting

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dictionary:

Inclusion Criteria

A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.

new FB feed (19)

dictionary:

Exclusion Criteria

A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.

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dictionary:

CSF

A clear fluid produced by the brain, which surrounds and supports the brain and spinal cord.

(from HDbuzz.org)