Start: September 5, 2019
End: October 2023
What Is This Study About?
This Phase 2 study will evaluate the safety and tolerability of the investigational drug K0706 in people with Lewy body dementia (LBD). Participants will be randomly assigned to one of two doses of the study drug (92-mg or 196-mg capsule) or placebo by mouth daily for 12 weeks. In addition to evaluating safety and tolerability, researchers will measure changes in biomarkers for LBD in cerebrospinal fluid and blood, as well as changes in cognitive, behavioral, and motor functioning.
Do I Qualify To Participate in This Study?
- Diagnosis of DLB with both dementia (Montreal Cognitive System score of 14 or more) and parkinsonian (defined as slowness of movement in combination with rest tremor, rigidity, or both Unified Parkinson Disease Rating Scale [UPDRS] I-III score of 50 or less and UPDRS-III between 20 to 40)
- Dementia and parkinsonism must be present with at least one other symptom such as fluctuation, visual hallucinations, or REM sleep behavioral disorder
- Stable on levodopa (no more than 800 mg daily), acetylcholinesterase inhibitors, and dopamine agonists for at least six weeks
- Stable on monoamine oxidase inhibitors for at least four weeks
- Stable medical and/or psychiatric illnesses
- Corrected QT interval of 350 to 470 ms
- Willing to undergo lumbar puncture
Must NOT have:
- Medical history of liver disease, pancreatic disease, Crohn's disease, or kidney, gastrointestinal, or blood problems
- Abnormal liver function defined as aspartate aminotransferase and/or alanine aminotransferase above the upper limit of normal (ULN)
- Renal insufficiency (serum creatinine levels greater than 1.5 times ULN or proteinuria)
- History of HIV, significant chronic hepatitis, or other active infection
- Hypokalemia, hypomagnesaemia, or long QT syndrome (QTc greater than 471 ms) or concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease
- History or presence of significant heart conditions, including heart attack, unstable angina, stroke, congestive heart failure, atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances, including torsades de pointes
- Prohibited medications (within past 30 days and over the course of the trial): Class IA or III antiarrhythmic drugs (e.g., quinidine), QT prolonging drugs excluding SSRIs
- Females must not be lactating, pregnant or with possible pregnancy
- Evidence of syndromes other than DLB, including Alzheimer's disease, idiopathic Parkinson's disease, corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, frontotemporal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, and Babinski sign
- Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness, or any active major psychiatric disorder including psychosis, major depression, bipolar disorder, and alcohol or substance abuse
- Evidence of any significant clinical disorder or laboratory finding including unstable blood, liver, heart, lung, gastrointestinal, endocrine, metabolic, kidney, or other systemic disease or laboratory abnormality
- Active neoplastic disease or history of cancer in past five years (history of skin melanoma or stable prostate cancer are not exclusionary)
- Inability to undergo lumbar puncture, including prior lumbar spine surgery, severe degenerative joint disease or deformity of the spine, platelets less than 100,000, use of warfarin, or history of a bleeding disorder
- Use of immunosuppressant medications
- Enrolled as an active participant in another clinical study
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Myrna Joy J Arellano, RN
Sara Matar, BS
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
Lead: Georgetown University
Sun Pharma Advanced Research Company Limited
Source: ClinicalTrials.gov ID: NCT03996460