Neurobiological Predictors of Huntington's Disease (PREDICT-HD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Iowa
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jane S. Paulsen, University of Iowa
ClinicalTrials.gov Identifier:
NCT00051324
First received: January 8, 2003
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

The purpose of this trial is to study early brain and behavioral changes in people who have the gene expansion for Huntington's disease, but are currently healthy and have no symptoms.


Condition
Huntington Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neurobiological Predictors of Huntington's Disease Trial

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Biospecimen Retention:   Samples With DNA

Plasma retained from 2000-2007. Urine, plasma and cell lines to be acquired and retained 2008-2013.


Estimated Enrollment: 1500
Study Start Date: August 2002
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Huntington's Disease (HD) is an inherited disease that causes changes in a person's ability to control movements, thinking, and feelings. The intent of this study is to learn more about the beginning changes in thinking skills, emotional regulation, and brain structure and function as a person begins the transition from health to HD.

Preliminary studies indicate that people with HD may have marked decline before an actual diagnosis. This study will help reveal the earliest indicators of the disease and what factors influence the age at which a person carrying the gene develops the disease. It is necessary to get information on the early stages of HD in order to develop drugs that can slow or postpone the onset of HD. The investigators hope this study will provide essential information for future trials of experimental drugs for HD.

During this study, participants will undergo several detailed tests, including MRI scans of the brain, cognitive assessments, physical exams, and neurological and psychiatric testing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD.

Criteria

Inclusion Criteria:

  • men and women at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD (CAG ≥36 for CAG-expanded group or CAG <36 for CAG-norm group).

Exclusion Criteria:

  • diagnosis of manifest HD (at least 50% confidence by neurologist that symptoms are present);
  • clinical evidence of unstable medical or psychiatric illness;
  • history of mental retardation;
  • history of other CNS disease or event (e.g., seizures or head trauma);
  • current or previous treatment with antipsychotic medications, including the traditional neuroleptics such as haloperidol as well as the atypical antipsychotics risperidone, clozapine, quetiapine, and olanzapine;
  • treatment with phenothiazine-derivative antiemetic medications such as prochlorperazine, metoclopramide, promethazine, and Inapsine on a regular basis (greater than 3 times per month);
  • pacemaker or metallic implants.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051324

Contacts
Contact: Sean Thompson 319-353-4307 predict-hd@uiowa.edu

  Hide Study Locations
Locations
United States, California
University of California-Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Brian Clemente    310-794-1225    BClemente@mednet.ucla.edu   
Principal Investigator: Susan Perlman, MD         
University of California-Davis Recruiting
Sacramento, California, United States, 95817
Contact: Terry Tempkin    916-734-6278    teresa.tempkin@ucdmc.ucdavis.edu   
Principal Investigator: Vicki Wheelock, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Gigi Satris    415-476-2909    gsatris@memory.ucsf.edu   
Principal Investigator: Michael Geschwind, MD PhD         
United States, Colorado
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
Contact: Diane Erickson    303-762-6674    derickson@thecni.org   
Principal Investigator: Rajeev Kumar, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30329
Contact: Cathy Wood-Siverio    404-728-4782    cwoodsi@emory.edu   
Principal Investigator: Randi Jones, PhD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Kimberly Quaid    317-274-2390    kquaid@iupui.edu   
Principal Investigator: Kim Quaid, PhD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Pat Ryan    319-353-4212    pat-ryan@uiowa.edu   
Principal Investigator: Eric Epping, MD PhD         
United States, Kansas
Hereditary Neurological Disease Center Recruiting
Wichita, Kansas, United States, 67206
Contact: Greg Suter    888-232-4632      
Principal Investigator: William Mallonee, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Nadine Yoritomo    410-955-1349    nyorito@jhmi.edu   
Principal Investigator: Chris Ross, MD PhD         
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Stacey Barton    314-362-3471    bartons@neuro.wustl.edu   
Principal Investigator: Joel Perlmutter, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Paula Wasserman    212-305-4597    pleber@sergievsky.cpmc.columbia.edu   
Principal Investigator: Pietro Mazzoni, MD, PhD         
Sub-Investigator: Karen Marder, MD, PhD         
University of Rochester Recruiting
Rochester, New York, United States, 14618
Contact: Amy Chesire    585-341-7519    amy_chesire@urmc.rochester.edu   
Principal Investigator: Fred Marshall, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Christine Reece    216-445-9833    houserc@ccf.org   
Principal Investigator: Anwar Ahmed, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Alma Macaraeg    206-277-1825    almam@uw.edu   
Principal Investigator: Ali Samii, MD         
Australia
The University of Melbourne--St. Vincent's Health Service Recruiting
Melbourne, Australia
Contact: Joy Preston    61 3 9272 0436    joy.preston@svmh.org.au   
Principal Investigator: Olga Yastrubetskaya, PhD         
The University of Melbourne, Royal Melbourne Hospital Recruiting
Melbourne, Australia
Contact: Angela Komiti    61-38345510    angelaak@unimelb.edu.au   
Principal Investigator: Phyllis Chua, MD         
The Mount Medical Centre Recruiting
Perth, Australia
Contact: Steve Andrew    0893476464    steve.andrew@health.wa.gov.au   
Principal Investigator: Peter Panegyres, MD         
Westmead Hospital Recruiting
Sydney, Australia
Contact: Jane Griffith    011-61-2-98456793    jane_griffith@wsahs.nsw.gove.au   
Principal Investigator: Clement Loy, MD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Pam King    780-735-8852    pam.king@capitalhealth.ca   
Principal Investigator: Wayne Martin, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Joji Decolongon    604-822-7928    joji@cmmt.ubc.ca   
Principal Investigator: Lynn Raymond, MD PhD         
Canada, Ontario
University of Toronto Recruiting
Toronto, Ontario, Canada
Contact: Irita Kalmalkar    905-472-7082 ext 29    ikalmalkar@movementdisorders.ca   
Principal Investigator: Mark Guttman, MD         
Germany
University of Ulm Recruiting
Ulm, Germany
Contact: Katrin Barth    49 731 500 50967      
Principal Investigator: Sigurd Suessmuth, MD         
United Kingdom
Clinical Genetics Centre Recruiting
Aberdeen, United Kingdom
Contact: Daniella Rae    44-1224-552120    d.rae@nhs.net   
Principal Investigator: Zosia Miedzybrodzka, MD         
Cambridge Centre for Brain Repair Recruiting
Cambridge, United Kingdom
Contact: Sarah Mason    01223 331160    slm64@cam.ac.uk   
Principal Investigator: Roger Barker, MBBS MRCP         
Cardiff University Recruiting
Cardiff, United Kingdom
Contact: Kathy Price    02920875197    priceka2@cardiff.ac.uk   
Principal Investigator: Anne Rosser, MD PhD MRCP         
National Hospital for Neurology and Neurosurgery Recruiting
London, United Kingdom
Contact: Maggie Burrows    44 207 830 2869    m.burrows@medsch.ucl.ac.uk   
Principal Investigator: Tom Warner, MD PhD         
University of Manchester Recruiting
Manchester, United Kingdom
Contact: Judith Bek    44 161 276 5956    judith.bek@manchester.ac.uk   
Principal Investigator: David Craufurd, MD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Jane S. Paulsen, Ph.D. University of Iowa
  More Information

Additional Information:
No publications provided

Responsible Party: Jane S. Paulsen, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT00051324     History of Changes
Other Study ID Numbers: R01NS040068, R01NS040068
Study First Received: January 8, 2003
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Iowa:
Huntington's disease
Huntington disease
HD

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014