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 |
Show 27 Study Locations| 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 Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases |
Genetic Diseases, Inborn Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Chorea Dyskinesias |
ClinicalTrials.gov processed this record on May 19, 2013