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192 mg powder of K0706 for Dementia
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.
- Dementia with Lewy Bodies (DLB)
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- The corrected QT interval (QTc) is 350-470 ms, inclusive.In the judgement of the PI, stable concomitant medical and/or psychiatric illnesses are considered when making a decision about whether or not to study a particular participant.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.The person must have been stable on an MOA-B for at least 4 weeks before enrolling in the study and during the study.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 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.People who take part in the study must be willing to have a Lumbar puncture (a procedure in which a needle is inserted into the spinal canal to remove a sample of cerebrospinal fluid for examination) done at the beginning and end of the study.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.
- Group 1: 192 mg powder of K0706
- Group 2: Placebo powder
- Group 3: 384 mg powder of K0706
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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