Huntington Disease Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability, and Efficacy of PBT2 in Patients With Early to Mid-stage Huntington Disease
Huntington disease (HD) is an inherited neurodegenerative disease which affects over 30,000
people in both the United States and Australia. HD is characterized by brain cell death that
usually begins between the ages of 30 to 50, and results in motor, cognitive and behavioral
signs and symptoms. While there are medications to help relieve some of the disease
symptoms, there is no known treatment to address the cognitive impairment associated with
HD.
Normally occurring metals in the brain play a significant role in diseases such as Alzheimer
disease and more recently, HD. PBT2 is a drug designed to interrupt interactions between
these biological metals and target proteins in the brain, to prevent deterioration of brain
cells. PBT2, has shown in animal models, and as well as in a small group of patients with
Alzheimer's disease, it may improve cognition. There is some indication in animal models of
HD, that the drug may improve motor function and control and reduce the amount of brain cell
degeneration. Based on these results, this clinical trial is investigating whether the drug
will have similar effects with HD patients.
PBT2-203 will evaluate how safe and well tolerated PBT2 is at a dose of 100 mg or 250 mg a
day administered as oral daily capsules compared to a placebo over six months treatment
period. The trial will also measure whether there is an effect on cognitive abilities as
well as other HD symptoms including motor and overall functioning of individuals with HD.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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