Actively Recruiting
K0706 for Patients Diagnosed With Dementia With Lewy Bodies
Led by Georgetown University · Updated on 2022-10-19
45
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
G
Georgetown University
Lead Sponsor
S
Sun Pharma Advanced Research Company Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
K0706 for Patients Diagnosed With Dementia With Lewy Bodies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent provided
- Able to provide informed consent or have a Legally Authorized Representative
- Age between 25 and 90 years, medically stable
- Clinical diagnosis of Dementia with Lewy Bodies with dementia MoCA score 14 or higher
- Presence of Parkinsonian symptoms with specified UPDRS scores
- Dementia and Parkinsonism plus at least one symptom such as fluctuation, visual hallucinations, or REM sleep behavioral disorder
- Stable on Levodopa (up to 800 mg daily), acetylcholinesterase inhibitors, dopamine agonists for at least 6 weeks
- Stable on monoamine oxidase inhibitors (MOA-B) for at least 4 weeks before and during the trial
- Stable concomitant medical and/or psychiatric illnesses as judged by principal investigator
- Corrected QT interval (QTc) between 350 and 470 ms inclusive
- Willing to undergo lumbar puncture at baseline and after 3 months
You will not qualify if you...
- History of liver or pancreatic disease, gastrointestinal ulcers, Crohn's disease, kidney, gastrointestinal, or blood problems
- Abnormal liver function with AST or ALT greater than 100% upper normal limit
- Renal insufficiency defined by serum creatinine over 1.5 times upper normal limit or proteinuria
- History of HIV, chronic hepatitis, or other active infections
- Hypokalemia, hypomagnesaemia, long QT syndrome with QTc 471 ms or above, or use of drugs prolonging QTc except SSRIs
- Significant cardiac conditions including myocardial infarction, angina, stroke, heart failure, arrhythmias, AV block, sick sinus syndrome, or Torsade de Pointes history
- Use of certain antiarrhythmic or QT prolonging drugs within 30 days before screening or planned use during trial
- Females who are pregnant, lactating, or possibly pregnant
- Clinical signs indicating other neurological syndromes besides DLB
- History or current epilepsy, focal brain lesions, major psychiatric disorders, substance abuse
- Significant clinical disorders or lab abnormalities making investigational drug unsuitable
- Active cancer or history of cancer within 5 years excluding skin melanoma or stable prostate cancer
- Contraindications to lumbar puncture
- Use of immunosuppressant medications
- Participation in another active clinical study
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Trial Site Locations
Total: 1 location
1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
Research Team
M
Myrna Joy J Arellano, RN
CONTACT
S
Sara Matar, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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