A Study to Assess the Tolerability and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment

Inclusion Criteria:

• On chronic hemodialysis due to end-stage renal disease for ≥ 12 months.
• Score on the Montreal Cognitive Assessment (MoCA) ≥ 16 and ≤ 23.
• Body mass index (BMI) ≥ 20 and ≤ 36.
• The subject must be able to follow the study protocol, receive the treatment in theestablished timeframe, and continue during the follow-up interval.
• The subject must have sufficient visual and auditory acuity to reliably complete allstudy assessments.
• Provided a signed and dated informed consent form.

Exclusion Criteria:

• Subjects for whom adequate anticoagulation cannot be achieved. Use of antiplateletdrugs (e.g., aspirin or clopidogrel) is allowed.
• History of hypersensitivity to heparin.
• Pregnant or breast-feeding women or women who are planning to become pregnant.
• Clinically significant abnormalities on Screening ECG including QT interval correctedfor heart rate (QTc) (using Fridericia's correction formula) of ≥ 500 ms in men and ≥ 520 ms in women.
• Clinically significant and unexpected abnormalities in this patient population incomplete blood count, complete metabolic panel, coagulation, and thyroid stimulatinghormone (TSH).
• Subjects with a hemoglobin level < 9.0 g/dL.
• Concurrent or recent participation in another investigational clinical trial. Priorclinical trial subjects must have discontinued investigational agents at least 30 daysprior to Screening.
• Subjects planning to receive renal transplantation during the study.
• Any other condition and/or situation that the investigator believes may interfere withthe safety of the subject, study conduct, or interpretation of study data.