Pilot Study of MEND Protocol for Alzheimer’s Shows Results in Those with Mild Decline

At the recent Alzheimer’s Association International Conference (AAIC) 2016, held in Toronto, Canada, Muses Labs presented data from a pilot study of its MEND Protocol for treatment of early Alzheimer’s disease.

The few drugs available today to slow the progression of Alzheimer’s disease target individual brain factors. Plenty of research, however, shows that dementia is linked to an array of risk factors, suggesting that some form of a combination therapy is likely to be more effective.

But the factors involved also vary among individuals, and a one-combination-therapy-that-fits-all approach is unsuitable.  Muses Labs reports that it has found a way to address these issues simultaneously in each individual patient.

MEND Protocol is a multi-step cognitive evaluation process, that uses advanced data processing technology to first assess which risk factors are present in an individual. According to the company, more than 50 drivers of cognitive decline exist, of which the top 12 are low thyroid hormone levels, high homocysteine levels, bad diet, insulin resistance, ApoE4, imbalance in metals, stress, depression, elevated blood fats, low exercise, poor sleep, and inflammation.

An initial examination, therefore, includes a genetic analysis, medical history, and a lifestyle analysis in addition to laboratory test and cognitive screenings.

Taking these and additional risk factors into account, the Muses software then uses advanced algorithms to propose a treatment plan that can easily be adapted by a physician.

“Unlike drugs that address a single issue, our evidence-based combination approach targets the 50-plus known causes of cognitive decline that often exist simultaneously,” Vik Chandra, Muses Labs CEO, told Alzheimer’s News Today. “In addition to FDA-approved medications, our solution also includes supplements and lifestyle changes personalized for a patient’s specific needs.

“It is important to note that patients can benefit from our methodology today. The methodology does not depend upon unapproved medications,” he added.

According to Muses, the MEND protocol invariably needs more than just a consultation with a physician. Given the complex nature of the intervention, which includes lifestyle changes, coaching is an integral part of the treatment. Once a patient’s data is processed and a treatment plan is set, a patient receives coaching once a week with follow-up in three-month cycles.

The coaching is intended to overcome the inertia to introduce lifestyle changes, and a coach starts by prioritizing goals that quickly produce measurable results to increase encouragement.

The pilot study, conducted in 19 patients, showed that in people at risk for Alzheimer’s but with no obvious decline, as well as in those with mild cognitive impairment, two or more cycles of the three-month intervention improved memory function and biomarkers of cognitive decline. But the intervention did not manage to lower levels of blood stress hormones.

For those in early stages of Alzheimer’s disease, the pilot study did not find evidence of improved cognition. But the study was small, and Muses plans to bring the protocol to randomized clinical trials for more rigid testing.

People who joined the study tended to be well-educated, and a large proportion of them had the ApoE4 gene — the most well-known genetic Alzheimer’s risk factor. The sample is, therefore, not representative of the general population, again showing the need for a randomized trial.

“As a society, we should develop combination approaches in addition to continuing the work on silver-bullet drugs. We should not leave any stone unturned,” said Chandra.

Besides testing the MEND protocol in larger, long-term studies, Muses Labs is now exploring partnerships to bring a direct-to-consumer offering focused on optimizing cognitive function to the market.