Time-Restricted Eating in Huntington's Disease: A Clinical Pilot Study

Eligibility Criteria

• 1. Are of at least 21 years of age at Screening.
• 2. Must fulfill one of the following criteria:
• 1. Premanifest late prodromal HD as defined by a genetically confirmed CAG repeat greater than or equal to 36 and a CAG-Age Product (CAP) score greater than 368 (CAP = (Age) x (CAG - 33.66)).
• 2. Early manifest (stage I and II) HD as defined by a TFC greater than or equal to 7. Subjects must have been determined to have a clinical diagnosis of HD by the site investigator as defined by a diagnostic confidence level (DCL) of 4.
• 3. Must fulfill both of the following criteria:
• 1. Have undergone genetic testing with a known CAG repeat greater than or equal to 36.
• 2. No features of juvenile HD (Westphal variant)
• 4. All female subjects of childbearing potential must have a negative urine pregnancy test at baseline, and female subjects of childbearing potential must practice a highly effective method of contraception (e.g., oral contraceptives, a barrier method of birth control \[e.g. condoms with contraceptive foams, diaphragms with contraceptive jelly\], intrauterine devices, partner with vasectomy or sexual abstinence) for the duration of the study.
• 5. Are willing and capable of providing informed consent for study participation.
• 6. Are capable of reading, writing, and communicating effectively with others.
• 1. Have participated in an investigational drug or device study within 30 days of the baseline visit
• 2. Have had previous neurosurgery for Huntington's disease or other movement disorders.
• 3. Have clinically significant cognitive impairment that hinders the ability to appropriately consent or adhere to detailed study directions, in the opinion of the principal investigator.
• 4. Have a presence of clinically significant psychosis and/or confusional states, in the opinion of the principal investigator.
• 5. Have clinically relevant hematologic, hepatic, cardiac, thyroid, or renal disease.
• 6. Have a history of substance abuse (based on DSMIV criteria) within the past 12 months prior to screening.
• 7. If female, are pregnant or breastfeeding.
• 8. Have a high-risk for nutritional deficiency.
• 9. Are not weight stable for at least three months prior to enrolling in the study, defined as greater than 2 kg change in body mass.
• 10. Express a desire to lose weight during the study.
• 11. Have a clinically significant medical, surgical, laboratory, or behavioral abnormality which in the judgment of the site Investigator makes the subject unsuitable for the study.
• 12. Have consistently practiced a time-restricted eating protocol within 3 months of trial onset.