Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
K0706 for Patients Diagnosed With Dementia With Lewy Bodies
NCT03996460 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03996460
The ClinicalTrials.gov registry entry for NCT03996460 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03996460 reports 1 study location spanning 1 distinct geographic area — top geographies include District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03996460?
This trial is sponsored by Georgetown University, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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