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NCT Number: NCT00051324

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Refine the prediction of disease diagnosis (motor conversion)

    Time frame: One year

    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.

  2. Characterize disease progression prior to diagnosis.

    Time frame: One year

    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.

  3. Establish possible validity and reliability of disease measures.

    Time frame: One year

    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.

Other outcomes

  1. Cerebral spinal fluid containing unique biomarker signatures.

    Time frame: One year

    Lumbar puncture is conducted at the University of Iowa

  2. Cerebral spinal fluid biomarker changes correlating with HD progression.

    Time frame: One year

    Lumbar puncture is conducted at the University of Iowa

Sponsors and collaborators

Lead sponsor

Jordan Schultz

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Neurobiological Predictors of Huntington's Disease Trial

Acronym: PREDICT-HD

Important dates

Study start
2002
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2003
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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