Vivimind: Forget About It

You’ve seen the billboards for Vivimind across Canada. Remember them?  Targeting an aging population of boomers, Vivimind is touted as a “scientifically proven” natural health product that “protects memory function”. The website goes to great lengths to promote that Vivimind is both “scientific” and “evidence based”. So let’s take a look at what sort of science supports the claims for Vivimind.

What condition does Vivimind treat?

Vivimind is marketed to treat mild memory decline, also called “Age Associated Memory Impairment” (AAMI).  Sometimes called “late life forgetfulness,” AAMI is a common condition that appears to be part the normal aging process.[1] Common symptoms include brief memory lapses, and difficulty remembering names and words. These symptoms are considered mild, and do not impact on one’s professional or social life. It can worsen as one ages, but you’re still able to function normally. AAMI is unrelated to degenerative neurological diseases like Alzheimer’s disease.

AAMI is common, with some estimates of up to one in three being affected between the age of 60 to 78.[2] While AAMI is not a disease, various strategies have been proposed to help maintain active function, such as exercise, keeping an active social life, languages, and games. No comprehensive evaluation of these interventions has been done.

AAMI appears to be a consequence of an aging body. It’s not severe, it’s not a degenerative disease, and it doesn’t signal the onset of Alzheimer’s disease.

What’s in Vivimind?

The active ingredient in Vivimind is 3-amino-1-propanesulfonic acid, also known as tramiprosate or homotaurine.  The manufacturer of Vivimind claims that the it is “based on the naturally occurring ingredient homotaurine” and “identical chemically to natural homotaurine.” This clarifies that the actual chemical in Vivimind is synthetic: it’s manufactured in a laboratory, and not naturally sourced.

What does the science say?

Vivimind was once a promising prescription drug.  It was called Alzhemed, and was hoped to be a breakthrough treatment for Alzheimer’s disease. [3] Alzheimer’s disease is a neurodegenerative process, where amyloid plaques form in the brain, leading to dementia. It was proposed that Alzhemed might reduce the deposits of plaque, slowing progression of the disease.

A preliminary study examined Alzhemed in mild-to-moderate Alzheimer’s disease. [4] Researchers studied its safety, tolerability, and pharmacokinetics (how the drug behaves in the body), but not whether the drug worked. Overall, the study found that Alzhemed was generally well tolerated and appeared safe. There was evidence to show that it did reach the brain. This was encouraging enough to support further studies to answer the question: Does the drug actually work?

Two major phase 3 trials were subsequently launched to test if Alzhemed could be an effective treatment for Alzheimer’s disease. Unfortunately, the results showed that patients taking Alzhemed did no better than patients taking a placebo. [3] The FDA concluded that the results could not support a claim of clinical efficacy – that is, the manufacturer could not claim the drug worked.[5] A European trial of Alzhemed was subsequently discontinued before the results were reported.

Case closed for Alzhemed? Not quite. After the failure of the phase 3 trial, where Alzhemed was shown to be ineffective, the manufacturer announced its intention to bring the product to market – but not as a treatment for Alzheimer’s.  Nope – they were going after a bigger market – people with age associated memory impairment. And forget about all that pesky evidence and data the FDA wanted. Since approval of Alzhemed as a prescription drug to treat Alzheimer’s disease seemed out of the question, the manufacturer, Neurochem, decided to market it as a natural health product. [3] [6] The company changed  its name to Bellus Health, and renamed the product Vivimind.

With respect to AAMI, the currently marketed use for Vivimind, there are no published trials to demonstrate any positive effects. In fact, there are no published trials at all that have examined Vivimind for AAMI.  Recall that AAMI is considered a natural consequence of ageing. There is currently no medical reason to treat AAMI with any drug, and  there are no demonstrated biological changes of AAMI that could be impacted by Vivimind.

So the science tells us that Vivimind is a failed prescription treatment for Alzheimer’s disease, and there is no science to support its current claims for treating AAMI.

Questionable claims

The website for Vivimind states “VIVIMIND^TM can help protect your brain cells during the normal course of aging”. The reference given for this statement, by Gervais et al, is not a clinical trial, and does not provide any evidence to support this statement. [7] Other statements are made about how Vivimind offers “Improved cognitive performance (remembering test instructions, verbal ability, language comprehension, planning and executing skills by 33% vs. placebo”  Sounds impressive. But the reference, sadly is “Data on file” –  likely the Alzheimer’s trial that failed to show Vivimind is better than a placebo.  In fact, the term “data on file” shows up frequently in the promotional material for Vivimind.  If the evidence is so persuasive, why hasn’t the manufacturer published it?

How safe is Vivimind?

According to their website,  Vivimind “is generally well tolerated at the recommended dose, some people may experience nausea, weight loss, dizziness or fainting.” The dosage of Vivimind is 1-2 tablets twice per day. No information is given (and no science exists) to tell you whether to take one tablet or two tablets at a time. However, based on the largest published trial, nausea and vomiting are more common when two tablets are taken twice per day.

No information is given about how long Vivimind should be taken. The published phase 2 trial followed patients for 17 months. There is no published data to demonstrate that Vivimind can be safely taken longer than this.

What do other groups think of Vivimind?

Here is the statement from the Alzheimer’s Association:

The Alzheimer’s Association does not support the use of the dietary supplement VIVIMIND – by people with Alzheimer’s disease or other dementia, family members of people with dementia, people worried about getting Alzheimer’s, or the general public.

At this time there is no statistically significant proof that VIVIMIND is an effective treatment for Alzheimer’s disease or any other related disorder. A Phase III clinical trial of the compound for Alzheimer’s disease failed – it showed no statistically significant benefit versus placebo for people with Alzheimer’s.

In addition there is no evidence of its claims to protect against memory loss, preserve the brain structures associated with memory and learning, or maintain mental skills and abilities in health individuals of any age.

Marketing such a product is not in the best interest of people with Alzheimer’s and their families, or the general public. It is misleading and exploits people who are worried and vulnerable.

Everyone wants better treatments for Alzheimer’s and dementia. However, proof of the value of all interventions – including medical treatments, lifestyle changes, and dietary supplement – must precede new products in the marketplace. This product does not have this proof.

This press release can be accessed here (PDF).

Here is the evaluation by the Centre for Science in the Public Interest:

The drug Alzhemed, doesn’t work. What to do? If you’re Bellus Health Inc. of Laval Quebec, you rename the drug Vivimind and launch it as “a new scientifically proven natural health product” that “protects memory function.”

You tell the public that your unpublished research found Vivimind  “to improve cognitive performance (verbal skills, memory, comprehensive ability, planning and execution skills) by 33% versus placebo.”

But you ignore the fact that Vivimind was tested only in Alzheimer’s patients, and that their mental skills deteriorated as quickly as those of Alzheimer’s patients who were given a placebo. [8]

So what’s the bottom line with Vivimind?

Vivimind could not meet the efficacy standard established for prescription drugs. It’s now marketed as a natural health product. There is no convincing evidence that it is an effective treatment for Alzheimer’s disease, Age Associated Memory Impairment, or any other medical condition.

What does this say about the regulatory system for Natural Health Products in Canada?

The marketing of Vivimind in Canada demonstrates that Canada’s regulatory framework is clearly incapable of protecting the health and safety of Canadians. It is astonishing that a drug that has been demonstrated in clinical trials to be ineffective can be subsequently sold in Canada – for an unrelated use and without any evidence – as a natural health product.

Vivimind demonstrates that there clearly two standards for health-related products in Canada: A high standard for prescription drugs and typical over-the-counter drugs, where evidence of efficacy and safety is required, and a seemingly non-existent one for anything marketed as a “natural health product”, where evidence of effectiveness clearly isn’t necessary.

Conclusion

Vivimind is available in Canada only because of a lax regulatory framework that has allowed an ineffective prescription drug to be rebranded and marketed as a natural health product.  Until data is published to show it is effective, there is no compelling reason for anyone to take Vivimind. Vivimind has no place in the science-based pharmacy, or in your medicine cabinet.

For More Information

Reference six by Mark Anderson provides an excellent overview of the saga of Neurochem, how it became Bellus Health, and how Alzhemed was rebranded to Vivimind.

References

[1] “Age Associated Memory Impairment” NYU Medical Center. http://www.med.nyu.edu/adc/forpatients/memory.html (Accessed April 2, 2009)

[2] Koivisto K, Reinikainen KJ, Hänninen T et al. Prevalence of age-associated memory impairment in a randomly selected population from eastern Finland. Neurology 1995;Apr;45(4):741-7.

[3] “Alzhemed” from Alzforum: Drugs In Clinical Trials. www.alzforum.org/dis/tre/drc/detail.asp?id=84 (Accessed March 31, 2009).

[4] Aisen, P., Saumier, D., Briand, R., Laurin, J., Gervais, F., Tremblay, P., & Garceau, D. (2006). A Phase II study targeting amyloid- with 3APS in mild-to-moderate Alzheimer disease Neurology, 67 (10), 1757-1763 DOI: 10.1212/01.wnl.0000244346.08950.64

[5] FDA Deems U.S. Alzhemed Trial Results Inconclusive. From Alzheimer Research Forum. (Accessed April 3, 2009) Available at: http://www.alzforum.org/new/detail.asp?id=1647

[6] Anderson M. Just watch me. National Post. Tuesday, September 9, 2008. (Accessed March 31, 2009)  Available at: www.nationalpost.com/story-printer.html?id=756578

[7] GERVAIS, F., PAQUETTE, J., MORISSETTE, C., KRZYWKOWSKI, P., YU, M., AZZI, M., LACOMBE, D., KONG, X., AMAN, A., & LAURIN, J. (2007). Targeting soluble Aβ peptide with Tramiprosate for the treatment of brain amyloidosis Neurobiology of Aging, 28 (4), 537-547 DOI: 10.1016/j.neurobiolaging.2006.02.015

[8] No thanks for the memories. Nutrition Action Healthletter.  Centre for Science in the Public Interest April 2009, page 8.