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NCT03996460 · ClinicalTrials.gov registry record · Phase 2
K0706 for Patients Diagnosed With Dementia With Lewy Bodies
A Phase 2 study of Dementia With Lewy Bodies, sponsored by Georgetown University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT03996460: Recruiting Phase 2 study of Dementia With Lewy Bodies, sponsored by Georgetown University.
NCT03996460 is a Phase 2 study of Dementia With Lewy Bodies that is actively recruiting participants, run by Georgetown University. The registered enrollment target is 45 participants, below the 469-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03996460, a Phase 2 study of Dementia With Lewy Bodies, is actively recruiting participants, sponsored by Georgetown University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The investigators will determine safety and tolerability by using the occurrence of adverse events (AEs) of interest, including myelosuppression, urinary, pancreatic and hepatic disorders, gastrointestinal (GI), kidney disorders, Corrected QT-interval (QTc)prolongation as per SPARC Ltd Investigator Brochure (IB).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 192 mg powder of K0706
- DRUG 384 mg powder of K0706
Study Locations (1)
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-09-05 |
| Est. Completion | 2023-10 |
| Phase | Phase 2 |
What NCT03996460 shows while recruiting
NCT03996460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 469-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Dementia With Lewy Bodies appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03996460 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03996460 about?
NCT03996460 is a clinical study titled "K0706 for Patients Diagnosed With Dementia With Lewy Bodies". 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 wi...
What is the current status of trial NCT03996460?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2019-09-05. Estimated completion is 2023-10.
What conditions does trial NCT03996460 study?
This clinical trial studies the following conditions: Dementia With Lewy Bodies.
What interventions are being tested in trial NCT03996460?
The interventions under investigation include: Placebo (DRUG), 192 mg powder of K0706 (DRUG), 384 mg powder of K0706 (DRUG).
Who is sponsoring clinical trial NCT03996460?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03996460 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia With Lewy Bodies
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03996460's enrollment target sits among peer trials
45 19th of 22 higher than 4 of 22 other Dementia With Lewy Bodies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia With Lewy Bodies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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