Promising Alzheimer’s treatment moves toward clinical trials

A promising new natural treatment for Alzheimer’s disease is moving toward clinical trials. This will be a major step forward as there is nothing on the market that slows the progression of Alzheimer’s.

Muraleedharan Nair, Michigan State University natural products chemist, has patented a botanical compound, withanamides. His spinoff company, Natural Therapeutics, will begin the trials as soon as funding is in place.

To date, none of the major pharmaceutical companies - Merck, Eli Lilly, Bristol-Myers Squibb - have been able to produce an effective treatment that passed human clinical trials, Nair said.

“This particular research has focused on Ashwagandha, an herbal remedy that’s been used in Eastern medicines for centuries,” he said. “Our compound withanamides may work to prevent Alzheimer’s disease at the onset, and it also could prevent its progression.”

While plants cannot be patented, compounds from it can. MSU holds the patent for withanamides, and earlier research revealed that the compound, found in the plants’ seeds, proved to be a powerful anti-oxidant - double the strength of what’s on today’s market. The potent compound has shown that it can protect cells against damaging attacks by a rogue protein - the earliest stage of Alzheimer’s.

Alzheimer’s begins when a specific protein starts breaking, or cleaving, at the wrong place to produce an unwanted fragment. This bad fragment, called BAP, stresses cells’ membranes, sparks plaque formation and eventually kills the cells. This attack begins in the frontal lobe, erasing memories and continuing its unrelenting assault deeper into the brain.

Symptoms of Dementia and Early Stage Alzheimer’s disease

  Diminished short-term memory
  Misplacing belongings in odd places; losing valuable belongings, like wallet or purse
  Difficulty finding the right word: “Tip of the tongue” syndrome
  Person seems “not himself” and shows uncharacteristic behaviors
  Lapses in judgment
  Difficulty with mental arithmetic and handling money
  Disorientation in unfamiliar places or situations
  May become apathetic or withdrawn, avoiding social situations
  More difficulty with routine tasks at work or at home, or may take longer to complete tasks
  Irritation or anger in response to increasing memory lapses

A complicating factor is that the majority of protein cleaving is a natural, healthy process. Pharmaceutical companies, however, have focused their efforts on blocking the tiny faction of bad cleaving of the protein producing BAP.

Promising Alzheimer's treatment moves toward clinical trials “Rather than trying to stop only the malevolent cleaving, our compound keeps the bad protein from entering the cell where it does its damage,” he said. “Our studies have shown that withanamides effectively protect the brain cells by neutralizing the effect of BAP.”

Nair, who holds nearly 90 U.S. and international patents, is using withanamides to interrupt the action of BAP, hence preventing Alzheimer’s at an early stage.

Nair and his collaborators published in Phytotherapy Research that withanamides protected mouse brain cells from BAP damage. A recent study, also published in Phytotherapy Research and using mouse models, showed that withanamides passed the blood brain barrier, the filter that controls what chemicals reach the brain. The results showed that the compound reached its intended target, passing the last test before advancing to human testing.

After the clinical trials, which could be conducted as quick as six to twelve months, Nair and Natural Therapeutics will pursue FDA approval.

Specific Examples of the Symptoms and Signs of Alzheimer’s disease

  Asks the same question repeatedly within the same conversation
  Puts car keys away in refrigerator
  Unable to recall word for “car” and then says in frustration, “The thing you drive to work in.”
  A normally shy person becomes uncharacteristically outgoing or talkative at a family gathering
  Agrees to buy services or products he/she doesn’t need from telephone sales person
  Finds it difficult to balance checkbook or figure out correct amount of money to pay for an item while shopping
  Forgets to eat, skips meals, or eats the same food every meal

“Dr. Nair discovered his molecule in a food-safe plant,” said Jim Richter, Natural Therapeutics President. “It’s also classified as GRAS - generally regarded as safe - by the FDA. This means that we can bypass many of the hurdles that slow synthetic molecules that need testing. By compressing the timeline dramatically, we’ll be able to save tens of millions of dollars, and if successful, bring an effective treatment to Alzheimer’s patients.”


This research was funded in part by MSU AgBioResearch.

Michigan State University has been working to advance the common good in uncommon ways for more than 150 years. One of the top research universities in the world, MSU focuses its vast resources on creating solutions to some of the world’s most pressing challenges, while providing life-changing opportunities to a diverse and inclusive academic community through more than 200 programs of study in 17 degree-granting colleges.


Layne Cameron
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Michigan State University

  Phytotherapy Research

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