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

Cognitive Impairment Clinical Trial

Official title:
A Randomized, Double-Blind, Phase 2a Study to Evaluate the Tolerability, Feasibility, and Efficacy of AKST1210 in Patients on Hemodialysis With Cognitive Impairment Associated With End-Stage Renal Disease

Clinical Trial Summary

This study will evaluate the tolerability, feasibility, and efficacy of the AKST1210 column in subjects with end-stage renal disease with cognitive impairment (ESRD-CI) undergoing hemodialysis 3 times per week.

Clinical Trial Description

In this study, approximately 26 men and women on dialysis due to end stage renal disease and who have cognitive impairment will be randomly assigned to receive AKST1210 or control during each hemodialysis session for 3 months. The primary objective is to assess the safety and tolerability of AKST1210, and secondary objectives include changes in cognitive assessments as well as the feasibility of using AKST1210 in this setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04527328
Study type Interventional
Source Alkahest, Inc.
Contact
Status Completed
Phase N/A
Start date April 28, 2020
Completion date June 4, 2021
View Details
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