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PQ912 for Alzheimer's Disease (VIVA-MIND Trial)
VIVA-MIND Trial Summary
This trial will have two parts. In the first part, 180 people will take either a placebo or one of three different doses of the drug being studied. This will go on for at least 24 weeks. The second part, which will only happen if the first part shows promise, will involve 414 people taking the drug or a placebo for a longer period of time to see if it improves cognitive function and has other benefits.
VIVA-MIND Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VIVA-MIND Trial Design
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- You have had a major depressive episode in the last 6 months.You have had seizures in the past two years.You must be between 50 and 89 years old when you are checked to see if you can join the study.Your Mini-Mental State Examination (MMSE) score is between 20 and 30.You cannot have a lumbar puncture or MRI for medical reasons.Your Montreal Cognitive Assessment score is less than 26 during screening.You have severe brain diseases like Parkinson's, Huntington's, or certain types of dementia other than Alzheimer's.You have liver problems that are classified as Child-Pugh class A or more severe.You have a specific pattern in your spinal fluid that shows signs of Alzheimer's disease.You have early signs of memory problems based on a test done during screening.You had a brain MRI scan in the last 6 months that shows signs of Alzheimer's disease.You have had uncontrolled bipolar disorder in the last five years.You have been diagnosed with schizophrenia in the past.You have been diagnosed with possible Alzheimer's disease according to specific guidelines from the National Institute on Aging and the Alzheimer's Association.You have a history of bad skin reactions to medications or currently have a bad skin and tissue disease.You have been diagnosed with mild memory and thinking problems related to Alzheimer's disease.
- Group 1: 600 mg
- Group 2: Placebo
- Group 3: 300 mg
- Group 4: 150 mg
- 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
How many medical facilities are currently participating in this research endeavor?
"Currently, 16 medical centres are participating in this trial. These locations span from Syracuse to Chicago and Poway; it is recommended that prospective patients choose a location nearby so as to reduce the burden of travel associated with participation."
Is there currently an opportunity to enroll in this experiment?
"Affirmative, the information listed on clinicaltrials.gov implies that this research venture is actively recruiting applicants. The study was initially posted to the website in November of 2021 and most recently updated in October of 2022 with 414 patients being sought at 16 medical settings."
What is the current patient count of this clinical trial?
"The sponsor of this clinical trial, Vivoryon Therapeutics N.V., needs to recruit 414 individuals that meet the inclusion criteria in order for it to be successful. This research will take place at SUNY Upstate Medical University in Syracuse, Illinois, and Northwestern University Feinberg School of Medicine in Chicago, California."
Is the age of eligibility for this research trial limited to individuals younger than 30?
"According to the requirements of this trial, participants must be at least 50 years old and no older than 89."
What criteria must potential participants meet in order to be eligible for this trial?
"This medical trial is actively seeking 414 elderly people (aged 50 to 89) suffering from Alzheimer's disease. In addition, enrollees must have a Mini-Mental State Examination score of 20-30, and they must obtain lower than 26 on the Montreal Cognitive Assessment test. Furthermore, participants need to be evaluated with a Global Clinical Dementia Rating of 0.5 or 1 with a Memory Score above 0.5; finally, applicants should have an acquaintance who can regularly interact them (minimum 3 times per week). This companion needs to attend all clinic visits as well as aid in following study protocol."
What potential side effects should people be aware of when taking PQ912?
"Our experts at Power assigned PQ912 a score of 2, recognizing the lack of efficacy data, though evidence suggests that it is safe."
Who else is applying?
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