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192 mg powder of K0706 for Dementia
Phase 2
Waitlist Available
Led By Fernando L Pagan, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing a new drug, K0706, for safety and tolerability in people with Dementia with Lewy Bodies. The hypothesis is that the drug will be safe and will alter biomarkers in the CSF and plasma. Clinical assessments of cognitive, behavioral and motor functioning will also be evaluated.
Eligible Conditions
- Dementia with Lewy Bodies (DLB)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evidence of treatment-emergent adverse effects (safety and tolerability)
Secondary study objectives
Measurement of Biomarker concentration in CSF
Measurement of Biomarker concentration in plasma
Measurement of K0706 concentration in CSF
+1 moreOther study objectives
Measurement of the effects of K0706 on Cognition using the Montreal Cognitive Assessment (MoCA)
Measurement of the effects of K0706 on Cognition using the Trail Making Test (TMT)
Measuring the effects of K0706 on Behavior using the Alzheimer's disease Cooperative Study-Activity of Daily Living scale.
+7 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: 192 mg powder of K0706Active Control1 Intervention
Forty five (45) participants will be recruited and randomized into 3 arms (1:1:1) .Fifteen (15) patients in arm 2 (group 2) will receive the 192 mg powder of K0706 ( equivalent to 96 mg capsule of K0706) orally once daily for 12 weeks (90 days).
Group II: 384 mg powder of K0706Active Control1 Intervention
Forty five (45) participants will be recruited and randomized into 3 arms (1:1:1) .Fifteen (15) patients in arm 3 (group 3) will receive the 384 mg powder of K0706 (equivalent to 192 mg capsule of K0706) orally once daily for 12 weeks(90 days).
Group III: Placebo powderPlacebo Group1 Intervention
Forty five (45) participants will be recruited and randomized into 3 arms (1:1:1). Fifteen (15) patients in arm 1 (group 1) will receive the matching placebo powder orally once daily for 12 weeks (90 days).
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Who is running the clinical trial?
Sun Pharma Advanced Research Company LimitedIndustry Sponsor
32 Previous Clinical Trials
4,542 Total Patients Enrolled
Georgetown UniversityLead Sponsor
347 Previous Clinical Trials
137,071 Total Patients Enrolled
4 Trials studying Dementia
1,098 Patients Enrolled for Dementia
Fernando L Pagan, MDPrincipal InvestigatorGeorgetown University
4 Previous Clinical Trials
195 Total Patients Enrolled
2 Trials studying Dementia
86 Patients Enrolled for Dementia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- According to the study by McKeith et al, a clinical diagnosis of DLB can be made if a person has both dementia and Parkinsonian symptoms, with dementia scored at 14 or higher on the MoCA scale, and Parkinsonian symptoms including bradykinesia and rest tremor, rigidity, or both with a score of 50 or lower on the UPDRS I-III scale, and a score of between 20 and 40 on the UPDRS-III scale.You have been diagnosed with a specific type of dementia called dementia with Lewy bodies (DLB) and also show symptoms of Parkinson's disease like slow movement, tremors, and stiffness.You have dementia or Parkinsonism, along with at least one other symptom like changes in alertness, seeing things that aren't there, or acting out dreams while sleeping.You have been taking a specific dose of Levodopa, acetylcholinesterase inhibitors, and dopamine agonists for at least 6 weeks without any major changes.You do not have signs or a history of other brain disorders like Alzheimer's disease, Parkinson's disease, or other conditions that affect movement and cognition.You have had liver or pancreatic disease, stomach ulcers, Crohn's disease, kidney problems, gastrointestinal issues, or blood disorders in the past.You have had seizures, brain injuries, or mental health disorders like depression or substance abuse in the past two years.You have had a serious heart condition in the past, such as a heart attack or heart failure, or you have certain heart rhythm problems.
Research Study Groups:
This trial has the following groups:- Group 1: 192 mg powder of K0706
- Group 2: Placebo powder
- Group 3: 384 mg powder of K0706
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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