K0706 for Patients Diagnosed With Dementia With Lewy Bodies

Inclusion Criteria:

1. Written informed consent
2. Capable of providing informed consent and complying with study procedures. Subjectswho are unable to provide consent may use a Legally Authorized Representative (LAR)
3. Age of 25-90 years, medically stable
4. Clinical diagnosis of DLB according to McKeith et al (https://www.ncbi.nlm.nih.gov/pubmed/28592453) with both dementia MoCA≥14 andParkinsonian defined as bradykinesia in combination with rest tremor, rigidity or bothUPDRS I-III ≤ 50 and UPDRS-III between 20-40.
5. Dementia and Parkinsonism must be present with at least one other symptom such asfluctuation, visual hallucinations or REM sleep behavioral disorder (RBD)
6. Stable on Levodopa no more than 800mg daily, acetylcholinesterase inhibitors, dopamineagonists for at least 6 weeks
7. Stable on monoamine oxidase inhibitors (MOA-B) for at least 4 weeks before enrollmentand during the trial
8. Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI
9. Corrected QT interval (QTc) 350-470 ms, inclusive
10. Participants must be willing to undergo Lumbar puncture (LP) at baseline and 3 monthsafter treatment.

Exclusion Criteria:

1. Medical history of liver or pancreatic disease, GI ulcers and Chron's disease, kidney,GI, or blood problems
2. Abnormal liver function defined as Aspartate aminotransferase ( AST) and/or Alanineaminotransferase (ALT) > 100% the upper limit of the normal
3. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit ofnormal or proteinuria
4. History of Human immunodeficiency virus (HIV), clinically significant chronichepatitis, or other active infection
5. Hypokalemia, hypomagnesaemia, or long QT syndrome- QTc≥471 ms or concomitant drugsknown to prolong the QTc interval and history of any cardiovascular disease, includingmyocardial infarction or cardiac failure, angina, arrhythmia
6. History or presence of significant cardiac conditions including: cardiovascular orcerebrovascular event (e.g. myocardial infarction, unstable angina, or stroke),congestive heart failure, first, second- or third-degree atrioventricular block, sicksinus syndrome, or other serious cardiac rhythm disturbances, any history of Torsadede Pointes.
7. Treatment with any of the following drugs at the time of screening or the preceding 30days, and/or planned use over the course of the trial: Treatment with Class IA or IIIantiarrhythmic drugs (e.g. quinidine), treatment with QT prolonging drugs (www.crediblemeds.org)- excluding SSRIs (e.g. Citalopram, Escitalopram, Paroxetine,Sertraline, Duloxetine, Trazodone, etc.). Should treatment with any of these agents berequired, therapy with K0706 should be interrupted.
8. Females must not be lactating, pregnant or with possible pregnancy
9. Clinical signs indicating syndromes other than DLB including, AD idiopathic PD,corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronictraumatic encephalopathy, signs of frontal dementia, history of stroke, head injury orencephalitis, cerebellar signs, early severe autonomic involvement, Babinski sign
10. Current evidence or history in past two years of epilepsy, focal brain lesion, headinjury with loss of consciousness or Diagnostic and Statistical Manual of MentalDisorders 4th Edition ( DSM-IV) criteria for any active major psychiatric disorderincluding psychosis, major depression, bipolar disorder, alcohol or substance abuse
11. Evidence of any significant clinical disorder or laboratory finding that renders theparticipant unsuitable for receiving an investigational drug including clinicallysignificant or unstable hematologic, hepatic, cardiovascular, pulmonary,gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratoryabnormality.
12. Active neoplastic disease, history of cancer five years prior to screening, includingbreast cancer (history of skin melanoma or stable prostate cancer are notexclusionary)
13. Contraindications to LP: prior lumbosacral spine surgery, severe degenerative jointdisease or deformity of the spine, platelets < 100,000, use of Coumadin/warfarin, orhistory of a bleeding disorder.
14. Must not be on any immunosuppressant medications
15. Must not be enrolled as an active participant in another clinical study.