Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT03996460
PHASE2

K0706 for Patients Diagnosed With Dementia With Lewy Bodies

Sponsor: Georgetown University

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of K0706 on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics and Clinical Outcomes in Dementia With Lewy Bodies (DLB)

Key Details

Gender

All

Age Range

25 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2019-09-05

Completion Date

2023-10

Last Updated

2022-10-19

Healthy Volunteers

No

Interventions

DRUG

Placebo

Fifteen (15) patients in group 1 will receive the sachet of matching placebo ( equivalent to a capsule of placebo"sugar pill") orally daily for 12 weeks (90 days) without food.

DRUG

192 mg powder of K0706

Fifteen (15) patients in group 2 will receive the sachet of 192 mg powder of K0706 ( equivalent to 96 mg capsule of K0706) orally for 12 weeks (90 days) without food.

DRUG

384 mg powder of K0706

Fifteen (15) patients in group 3 will receive the 384 mg powder of K0706 (equivalent to 192 capsule of K0706) orally daily for 12 weeks (90 days) without food.

Locations (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States