The “Phase II” study was led by Thomas Shea, PhD, of the University of Massachusetts-Lowell, who had developed the formulation over a period of years. The formula was licensed to Sevo Nutraceuticals in 2012, by which time all of the proof of concept work and the first round of clinical trials had been completed the Phase II study was underway, Shea said.
“The results were as good as our Phase I studies. The original study population was small but the results were great. We approached the Alzheimer’s Association and based on the results they agreed to fund this larger study. In this study we have more than 100 participants,” Shea told NutraIngredients-USA.
Care with claims
Shea said he was well aware that even with the promising results for the formulation, the marketing of the supplement must avoid any mention of a disease claim.
“We know that this stuff is, pure and simple, good brain food,” Shea said. “We know from our earlier work that people improved and held that improvement for as much as two and a half years. If they improve from 'moderate' cognitive impairment to 'mild,' that can make a significant difference in their quality of life.”
Large scale and long term
The study was conducted at six different sites from 2010 through 2012. Participants received either Perceptiv, which is a mix of Vitamin E, Folic Acid, Vitamin B12 and a proprietary blend of N-Acetyl Cysteine, Acetyl L-Carnitine and S-Adenosyl Methionine (SAMe), or a placebo for a three month period. Primary results were measured by the scores on the Clox-1 and the the age- and education-adjusted (AEMSS) Dementia Rating Scale (DRS), which well-accepted standardized tests of cognitive function.
“All of the tests we utilized are standard tests that a physician would employ if we went in, or a relative brought us in, questioning our memory. They would administer these tests to get a baseline,” Shea said. “In one of those tests in particular the results are scored on a scale of mild, moderate or severe dementia. Our participant pool had scores that classified them as suffering from moderate dementia.”
Improvements in primary and secondary measurements
Participants who received Perceptive showed statistically significant improvement in the scores on the two tests versus both the control groups and in comparison to their baseline scores at the beginning of the test. The placebo group showed no improvement on the tests.
The study included a open-label extension. In this period, participants showed improvement for a period up to nine months (the longest period measured in the study). Participants who were the placebo group for the first three months showed improvement in cognitive scores that matched the experiment groups in the ensuing six months.
Subjects receiving Perceptiv also showed improvement in measurements of the disease’s subsidiary effects such as depression and irritability. These secondary improvements are somewhat more difficult to characterize as they are the results of caregivers’ reports, which can be colored by the caregivers’ own mental states. These secondary symptoms can in some ways be more difficult for caregivers to deal with than the primary cognitive effects, Shea said.
“One measure of quality of life is cognitive performance. Cooking a meal, for example, involves complex memory. Our participants improved in simple memory, complex memory and in mood. That can be hard on caregivers such as if you have the same question over and over. Or if the affected person is anxious, irritable, apathetic or has a tendency to wander,” Shea said.
Source: Journal of Alzheimer’s Disease
Published online ahead of print, doi:10.3233/JAD-142499
“A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer’s Disease”
Authors: R. Remington, C. Bechtel, D. Larsen, et al.