PreventE4 is a double-blind, randomized clinical trial to address a question of whether high dose omega-3 or DHA supplementation has a role in individuals at risk of dementia or Alzheimer’s, based on APOE4 genotype. In this trial, 384 individuals were randomized to two grams of DHA versus placebo over a period of two years. The primary outcome was the change in the levels of DHA in cerebrospinal fluid in approximately half of those individuals...
PreventE4 is a double-blind, randomized clinical trial to address a question of whether high dose omega-3 or DHA supplementation has a role in individuals at risk of dementia or Alzheimer’s, based on APOE4 genotype. In this trial, 384 individuals were randomized to two grams of DHA versus placebo over a period of two years. The primary outcome was the change in the levels of DHA in cerebrospinal fluid in approximately half of those individuals. And secondary outcomes include changes in brain imaging markers such as volumetrics or connectivity. And an exploratory outcome was the change in cognition based on RBANS which stands for the Repeated Battery of Neuropsychological Testing. So that in a nutshell, preventive for recruited individuals who are at risk of dementia based on cardiovascular risk factors, low seafood consumption, and willing to be on the omega-3 supplement.
The study ended recruitment on May 1st, 2022 and I think 360 individuals were randomized out of the 364. And right now we have approximately a year and a half to finish the study itself. Recruitment has ended and we still have a year and a half to conclude the last visit. So the primary outcome is the amount of omega-3 that gets into the brain, and we expect that a positive outcome would mean that high dose DHA supplementation is efficient in enriching the brain with omega-3s. And suggests that this could be a possible correct dose for DHA supplementation for the purpose of AD prevention.
Now, that doesn’t translate into a clinical recommendation. In fact, clinical recommendations require much larger studies and more comprehensive cognitive outcomes. We will use the data from PreventE4 to take the next step forward, whether it’s going to be more mechanistic studies to understand the metabolism of omega-3s or a Phase III clinical trial using high dose DHA at risk participants. One thing I didn’t mention, that 50% of the individuals in PreventE4 or APOE4 carriers.
