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

Huntington Disease Clinical Trial

— PREDICT-HD  

Official title:

Neurobiological Predictors of Huntington's Disease Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00051324
• Other study ID #: 199904075
• Secondary ID: R01NS040068
• Status: Active, not recruiting
• Start date: August 2002
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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, bio specimen (blood, urine, cerebral spinal fluid) collection and neurological and psychiatric testing.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1700
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (including substance abuse);

• history of sever learning disability or mental retardation;

• history of other CNS disease or event (e.g., seizures or head trauma);

• current 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);

Specific exclusion criteria for the lumbar puncture:

• Current use of anti-coagulants

• Current use of anti-platelets

• Unable to provide consent for him/herself

Related Conditions & MeSH terms

• Huntington Disease

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral spinal fluid containing unique biomarker signatures.	Lumbar puncture is conducted at the University of Iowa	One year
Other	Cerebral spinal fluid biomarker changes correlating with HD progression.	Lumbar puncture is conducted at the University of Iowa	One year
Primary	Refine the prediction of disease diagnosis (motor conversion)	HD diagnosis will be better predicted by adding longitudinal change to the baseline measures of striatal and white matter volumes, tone-paced and speeded tapping score, stroop interference and motor score.	One year
Primary	Characterize disease progression prior to diagnosis.	Document change scores for each marker using its slope.; Comparisons of change rates across time will suggest measures best suited to clinical trials by large effect sizes and low variability.	One year
Primary	Establish possible validity and reliability of disease measures.	This will require that we continuously analyze recently collected data, remove items that are insensitive, and add new items to be tested throughout the course of the study. The power and sensitivity of future multi-site trials and studies depend on accurate measures of marker validity.; HD diagnosis will be better predicted by UHDRS total motor score following new standardized reliability training and by the tapping task under modified more challenging, conditions. Psychiatric and functional ratings will be improved with item response analyses and dynamic piloting of item edits to establish the most psychometrically sound items for clinical trials.	One year

External Links

•   PREDICT-HD YouTube Channel