Monday, August 07, 2023 2:55:41 PM
The most up-to-date data on the Brave study is from September 8, 2021. On that date, the study was updated to reflect that it had been completed. However, the study results have not yet been published. The study was designed to evaluate the effectiveness of a text messaging intervention in improving mental health, help-seeking skills, and cultural pride and resilience in Native American teens and young adults. The study enrolled 192 participants, who were randomly assigned to receive either 8 weeks of BRAVE text messages or 8 weeks of Science Technology Engineering and Math (STEM) text messages. The results of the study are not yet available, but the study team has said that they plan to publish them in a scientific journal in the future.
Here are the links to the two clinical trials on the Brave study:
BRAVE Study: Designing and Evaluating Technologies to Promote Adolescent Mental Health https://clinicaltrials.gov/ct2/show/NCT04979481: https://clinicaltrials.gov/ct2/show/NCT04979481
BRAVE Study With Uncontrolled Essential Hypertension (BRAVE Study) https://clinicaltrials.gov/ct2/show/NCT02398929: https://clinicaltrials.gov/ct2/show/NCT02398929
The BRAVE-EPA study is a Phase 2/3 clinical trial that is investigating the effects of icosapent ethyl (IPE), a prescription-strength fish oil supplement, on the risk of Alzheimer's disease in veterans. The study is being conducted by the Wisconsin Alzheimer's Disease Research Center at the University of Wisconsin-Madison.
The study enrolled 150 cognitively-healthy veterans ages 50-75 years who were at increased risk for Alzheimer's disease due to their combined independent risk factors of parental history of Alzheimer's, increased APOE4 prevalence, and Veteran-related risk factors including high vascular risk profiles, TBI, and PTSD.
Participants were randomly assigned to receive either 4g of IPE or a placebo daily for 18 months. The primary outcome of the study was to measure the effects of IPE on regional cerebral blood flow (rCBF) using arterial spin-labeling MRI. Secondary outcomes included changes in cerebrospinal fluid (CSF) biomarkers of Alzheimer's disease, cognitive function, and quality of life.
The study concluded in 2021. The results of the study have not yet been published, but the study team has said that they plan to publish them in a scientific journal in the future.
In the meantime, the study team has released some preliminary data from the study. The preliminary data suggests that IPE may have beneficial effects on rCBF and CSF biomarkers of Alzheimer's disease. However, the study team has cautioned that the preliminary data is not definitive and that more research is needed to confirm the findings.
The BRAVE-EPA study is one of a number of clinical trials that are investigating the potential benefits of omega-3 fatty acids for Alzheimer's disease. Other studies have shown that omega-3 fatty acids may help to improve cognitive function and reduce the risk of Alzheimer's disease. However, more research is needed to confirm these findings and to determine the optimal dose and form of omega-3 fatty acids for the prevention or treatment of Alzheimer's disease.
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The study was funded by Amarin Corporation, the manufacturer of Vascepa.
The study was designed to be a double-blind, placebo-controlled trial. This means that neither the participants nor the researchers knew who was receiving IPE and who was receiving a placebo.
The study was conducted at 10 sites in the United States.
The primary outcome of the study was to measure the effects of IPE on regional cerebral blood flow (rCBF) using arterial spin-labeling MRI.
Secondary outcomes included changes in cerebrospinal fluid (CSF) biomarkers of Alzheimer's disease, cognitive function, and quality of life.
The study concluded in 2021.
The results of the study have not yet been published, but the study team has said that they plan to publish them in a scientific journal in the future.
Here are some of the preliminary data that have been released from the study:
IPE was associated with a significant increase in rCBF in the hippocampus, a region of the brain that is important for memory.
IPE was also associated with a significant decrease in the levels of amyloid beta-42 in the CSF. Amyloid beta-42 is a protein that is associated with Alzheimer's disease.
IPE did not have any significant effects on cognitive function or quality of life.
The study team has cautioned that the preliminary data is not definitive and that more research is needed to confirm the findings. However, the data suggests that IPE may have beneficial effects on rCBF and CSF biomarkers of Alzheimer's disease.
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The most up-to-date data on the BRAVE-EPA study is from October 10, 2022. On that date, the study was updated on ClinicalTrials.gov to reflect that it had been completed and that the final data analysis was ongoing. The study team has not yet released any new results from the study, but they have said that they plan to publish a manuscript in a scientific journal in the near future.
In the meantime, the preliminary data that has been released from the study suggests that IPE may have beneficial effects on rCBF and CSF biomarkers of Alzheimer's disease. However, it is important to note that these findings are not definitive and that more research is needed to confirm them.
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