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GV1001 for Alzheimer's Disease
Study Summary
This trialis testing a drug (GV1001) to treat mild to moderate Alzheimer's disease by reducing the amount of proteins that damage the brain. In a completed study, the drug showed promising results and was safe.
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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- I have not been diagnosed with any other cancer in the last 5 years.My kidney function is low (CrCL <30 mL/min).I have been diagnosed with Alzheimer's disease by a specialist.I have a brain condition that could affect my thinking.I am a male and will use effective birth control during and for 3 months after treatment.You had a special brain scan or a spinal fluid test in the past 2 years that showed signs of a certain kind of brain problem.I have been treated with specific medications before.I have been diagnosed with vascular dementia.I am not pregnant, not breastfeeding, and follow specific birth control measures.My dementia is worsened or caused by abnormal lab results.You have been diagnosed with dementia from a cause other than the one being studied, and this was confirmed by brain scans and a neurological examination within the past 2 years.You have mild to moderate memory and thinking problems, as shown by a specific test score.I am not on medications that affect my thinking or memory tests.I've been on a steady dose of Alzheimer's medication for at least 12 weeks.My dementia may be caused by something other than Alzheimer's.My liver tests are not more than twice the normal limit.I can visit the study center for tests.You have taken a new, experimental treatment for Alzheimer's disease in the past 6 months.I have been treated with aducanumab or was part of a study involving it.I have had seizures, significant head injuries, or recent periods of unconsciousness.Your brain scans from the past 2 years show signs of Alzheimer's disease, and no other condition is causing dementia.You have known allergies or bad reactions to certain ingredients in the study products.You have had problems with alcohol or drugs in the past two years.You live in a care facility that provides a high level of support.I have a history of significant mental health issues.I am between 55 and 85 years old.My body weight is 35 kg or less.I have been taking an over-the-counter supplement for cognition at the recommended dose for at least 12 weeks.
- Group 1: GV1001 0.56 mg
- Group 2: GV1001 1.12 mg
- Group 3: Placebo
- 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
What additional research has been done concerning the efficacy of GV1001 0.56 mg?
"At present, a single active clinical trial is investigating the efficacy of GV1001 0.56 mg with no studies in Phase 3. Most trials related to this medication are centered around Miami, Florida; however two additional medical sites are also running research projects for GV1001 0.56mg."
Are there age limitations in regards to participation in this experiment?
"This trial is recruiting individuals between the age of 55 and 85 years old."
Is it possible to participate in this clinical research study?
"Prospective participants must have an Alzheimer's diagnosis and be aged between 55 to 85 years old in order to join this clinical trial. Approximately 180 people are being accepted into the program."
What is the current enrollment level for this research endeavor?
"Affirmative. Clinicaltrials.gov confirms the fact that this research study, which was initially published on October 5th 2022, is currently enrolling individuals. Approximately 180 participants must be recruited from two distinct medical facilities."
Has the 0.56 mg dose of GV1001 gained clearance from the FDA?
"Our experts at Power assigned a score of 2 to GV1001 0.56 mg's safety, due to the fact that it has been tested in Phase 2 trials and is known safe but efficacy data still needs further assessment."
Is this the inaugural iteration of this particular trial?
"Presently, there is one active trial for GV1001 0.56 mg in 2 cities and 1 country. This investigation into the potential therapeutic benefits of GV1001 0.56mg was sponsored by GemVax & Kael and began back in 2022 with a participant pool of 180 people across Phase 2 drug approval stages. Since then, 4 more studies have been conducted on this medication."
Are there still openings in this medical trial for volunteers?
"Information hosted on clinicaltrials.gov displays that this medical study is still looking for recruits; it was first uploaded to the website on October 5th 2022 and most recently updated on November 20th 2022."
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