K0706 for Patients Diagnosed With Dementia With Lewy Bodies

Summary

This study evaluates the safety and tolerability of treatment with K0706 in Dementia with Lewy Bodies (DLB). The hypothesis is that K0706 will be safe and tolerable and that this drug will alter CSF and plasma biomarkers in DLB. Clinical assessments of cognitive, behavioral and motor functioning will also be evaluated. A total of 45 participants will be randomized 1:1:1 into 3 groups (n=15/per group) to be treated with sachet of 192 mg powder of K0706 ( equivalent to 96 mg capsule of K0706) or sachet of 384 mg powder of K0706 (equivalent to 192 capsule of K0706) or sachet of matching placebo ( equivalent to a capsule of placebo) for 12 weeks, followed by 4-week wash-out period.

Timeline

Start

2019-09-05

Primary completion

2024-04-22

Completion

2024-04-22

Outcome

Outcome not reported

Stopped: “Interim analysis was performed for 442 patients who completed Part I of the PROSEEK study-(CLR\_18\_06); it did not show evidence of treatment benefit in patients receiving Vodobatinib.”

Drugs

Indications