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192 mg powder of K0706 for Dementia

Phase 2
Recruiting
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
Clinical diagnosis of DLB according to McKeith et al (https://www.ncbi.nlm.nih.gov/pubmed/28592453) with both dementia MoCA≥14 and Parkinsonian defined as bradykinesia in combination with rest tremor, rigidity or both UPDRS I-III ≤ 50 and UPDRS-III between 20-40.
Dementia and Parkinsonism must be present with at least one other symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study 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)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
You have dementia or Parkinsonism and experience at least one of the following: sudden changes in alertness, seeing things that aren't there, or acting out dreams during sleep.
Select...
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.
Select...
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.
Select...
You have been taking a specific dose of Levodopa, acetylcholinesterase inhibitors, and dopamine agonists for at least 6 weeks without any major changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evidence of treatment-emergent adverse effects (safety and tolerability)
Secondary outcome measures
Measurement of Biomarker concentration in CSF
Measurement of Biomarker concentration in plasma
Measurement of K0706 concentration in CSF
+1 more
Other outcome measures
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 more

Trial 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).

Find a Location

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
342 Previous Clinical Trials
126,557 Total Patients Enrolled
3 Trials studying Dementia
1,086 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

Media Library

K0706 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03996460 — Phase 2
Dementia Research Study Groups: 192 mg powder of K0706, Placebo powder, 384 mg powder of K0706
Dementia Clinical Trial 2023: K0706 Highlights & Side Effects. Trial Name: NCT03996460 — Phase 2
K0706 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03996460 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research involve people who are over 45 years old?

"According to the eligibility requirements listed, patients must be aged 25-90 to take part in this clinical trial. There are 26 trials for patients under 18 and 408 trials for seniors."

Answered by AI

What have been the observed side effects of K0706 192 mg powder?

"K0706 is a powder medication typically given in 192mg doses. Because this is only a Phase 2 trial, there is limited data on both its safety and efficacy. However, the available evidence suggests that it is safe to use."

Answered by AI

How many people are allowed to be a part of this research project?

"That is correct. According to the clinicaltrials.gov website, this study is still recruiting patients. The listing for this trial was first posted on September 5th, 2019 and last updated on October 17th, 2020. Currently, 45 people are needed to participate at a single location."

Answered by AI

Are there any open slots left for new participants in this clinical trial?

"From what is displayed on clinicaltrials.gov, this trial is still searching for patients to enroll. The original posting date was September 5th, 2019 with the most recent update being October 17th, 2020."

Answered by AI

Does this clinical trial have any eligibility requirements?

"Dementia patients that fall within the age range of 25 to 90 may qualify for this study. So far, 45 people have been accepted into the trial."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What site did they apply to?
MedStar Georgetown University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~8 spots leftby Mar 2025