The effects of this “phase II” trial were encouraging, and supported earlier results with the formula that was developed at U Mass and subsequently licensed by Sevo Nutraceuticals and branded as Perceptiv.
“The results confirm and extend what showed in our phase 1 studies,” said Shea.
Shea is also a member of the scientific board of Perceptiv, and noted that the university has a financial stake in the product. But this latest research on the formula, which is a blend of vitamin E, folic acid, vitamin B12 and a proprietary blend of N-acetyl L-cysteine, acetyl L-carnitine and S-adenosyl methionine (SAMe), was funded by the Alzehimer’s Association, he said, and the research findings will be presented at the annual Alzehimer’s Association International Conference in Boston in mid July.
“The dementia rating scale is broken down to four categories: cognitively intact, mild, moderate and severe. With people coming into the study, the average was moderate. After three months (of intervention with Perceptiv) the average was mild,” Shea told NutraIngredients-USA.
In the 3-month, randomized study, 141 individuals diagnosed with Alzheimer’s disease (AD) and 24 participants with Mild Cognitive Impairment (MCI) received the formula or a placebo. This was followed by an open label extension of 9 to 12 months using the formula. An additional 38 participants received the formula under open label conditions for 12 months. The primary outcome was defined as cognitive performance. Secondary outcomes were defined as behavioral and psychological symptoms of dementia and activities of daily living.
The results showed that those participants who received the preparation improved within 3 months on cognitive performance ascertained by the Clox-1 and the Dementia Rating Scale and their caregivers reported improvement in Neuropsychiatric Inventory. Participants who received the formula either continued to improve or maintained their earlier improvement during the open label extensions. Placebo group participants showed similar improvement to the test group in the first 3 months of the open label extension.
Mood impact significant
“The mood impact that we saw was even more significant than the cognitive improvements,” Shea said.
“Mood is a function of cognition. In Alzheimer’s, people can become clinically depressed, and that can become such a burden on the family. The mood impact of the formula has a very profound impact on the quality of life,” he said.
This latest study, which is under review, joins three other published studies on the whole formulation, said Sevo CEO Bernie Prusaczyk.
Mode of action
Clinical studies with Shea's team have thus farm been confined to cognition and mood. However, published laboratory studies have demonstrated that the formulation reduces oxidative damage to brain tissue, reduces generation of beta amyloid (the toxic protein associated by the neuron death and plaque formation associated with Alzheimer's) and maintains the production of the neutrotransmitter acetylcholine.
Perceptiv is currently marketed through pharmacies and independent natural channel stores. And Emerson Ecologics recently picked up the supplement for distribution through the practitioner channel.