Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Prana Biotechnology Limited
Age
25–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients who:
1. Provide signed informed consent in accordance with local regulations.
2. Have Huntington disease including clinical features of HD and a CAG repeat number ≥ 36.
3. Have a Total Functional Capacity between 6 and 13, inclusive.
4. Have cognitive impairment as demonstrated by a MoCA score of ≥ 12.
5. Are ≥ 25 years of age.
6. If taking tetrabenazine, have been on a stable dose for at least 3 months.
7. If female, are either a) of childbearing potential and compliant in using adequate birth control or b) not of childbearing potential.
8. If male, is either a) of reproductive potential and compliant in using adequate birth control or b) not of reproductive potential.
9. Have a study partner who is willing to provide consent and spends on average at least two hours a day for at least four days a week with the patient, is fluent in the English language, and who agrees to attend certain study visits and provide accurate information about the patient.
10. Are able to swallow oral capsules.
11. Are fluent in the English language for the administration of rating scales and have sufficient visual, hearing and motor skills to complete procedures.
You may not be if
Patients who:
1. Have an allergy to PBT2 or its excipients.
2. Have other known primary neurodegenerative disorders associated with dementia.
3. Have known dementia syndromes due to non-primary CNS disease.
4. Have another condition that in the investigator's judgment is resulting in clinically significant cognitive impairment.
5. In the opinion of the investigator, have any clinically significant uncontrolled medical or psychiatric illness, including history of seizures.
6. Have clinically significant cardiovascular, hepatic, renal, pulmonary, metabolic or endocrine disease that, in the opinion of the investigator, would interfere with an individual's participation in the study.
7. Have a calculated creatinine clearance at Screening of \<50mL/min.
8. Have a history of malignancy diagnosed within 2 years of Screening.
9. Are pregnant or lactating females.
Clareo Health | Effect of PBT2 in Patients With Early to Mid Stage Huntington Disease
