Neurobiological Predictors of Huntington's Disease (PREDICT-HD)
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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 |
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 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
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 |
People at risk for HD, who have been tested for the HD gene mutation, and who have not been diagnosed with symptoms of HD.
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| Contact: Stacie Vik | 319-353-3716 | Stacie-vik@uiowa.edu |
Hide Study 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 | |
| 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: | June 25, 2012 |
| 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 May 19, 2013