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

Sponsor:	University of Iowa
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00051324

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:

Genetics Home Reference related topics: chorea-acanthocytosis familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease

U.S. FDA Resources

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:	1100
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)

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 4-year 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 ≥39 for CAG-expanded group or CAG <30 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

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

Contacts

Contact: Stacie Vik

319-353-3716

Stacie-vik@uiowa.edu

Show 32 Study Locations

Sponsors and Collaborators

University of Iowa

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Jane S. Paulsen, Ph.D.

University of Iowa

More Information

Additional Information:

study website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Iowa ( Jane Paulsen, PhD, PREDICT-HD Principal Investigator )
ClinicalTrials.gov Identifier:	NCT00051324 History of Changes
Other Study ID Numbers:	R01NS40068
Study First Received:	January 8, 2003
Last Updated:	August 20, 2009
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 September 02, 2010