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PR release claiming memory loss reversal in Alzheimer’s disease impaired by study limitations, imprecise language

Pre and Post Testing Show Reversal of Memory Loss From Alzheimer’s Disease in Ten Patients

Our Review Summary

memory lossThis is a news release about an update of a small 2014 study on a program to reverse cognitive impairment associated with Alzheimer’s disease. The program includes as many as 36 interventions which must be followed. Right out of the starting gate the release misinforms by using the terms mild cognitive impairment, subjective cognitive impairment and Alzheimer’s disease interchangeably. They are not the same.

The study reports “unprecedented” improvement in 10 patients with “early Alzheimer’s (AD) or its precursors” who adhered to the protocol, dubbed “metabolic enhancement for neurodegeneration,” or MEND, for five to 24 months. All but one of the patients had genes (APOE) associated with Alzheimer’s. The news release provides data on just three of the cases in the study and does not discuss costs or potential challenges of adhering to this protocol.

The news release reveals that the developer of the program, University of California, Los Angeles neurology professor Dale Bredesen, M.D., has a deal to publish a book for lay readers in 2017. Moreover, researchers say their findings are strong enough to warrant widespread genetic testing so those at risk for the disease can receive preventive measures. The book deal and the recommendation of genetic testing are troubling since there are just a handful of case studies to back up the program. Bredesen himself is quoted in the news release acknowledging the need for large-scale clinical trials. But the minor use of cautious language in describing the study as “small” and the call for future larger trials do not make up for the intentional muddying of the symptoms of age-related memory loss and Alzheimer’s disease.

 

Why This Matters

As the news release points out, Alzheimer’s disease is a huge and growing problem, affecting 5.4 million Americans and creating an economic burden on the health care system. No medications are available to stop its progress. There’s evidence that non-drug interventions that are designed to fight inflammation and improve blood sugar regulation like those in the MEND program could be effective. The MEND program includes the elimination of processed foods, regular exercise, yoga and medication to reduce stress, melatonin to extend sleep, supplements such as fish oil, vitamins D3 and B12, and hormone replacement therapy. However, the MEND treatment protocol involves so many factors it may be difficult to determine which ones are effective.

To date nothing has been proven to prevent Alzheimer’s. Medications are available but they are expensive, may delay progression marginally, and have side effects.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release does not discuss the cost of this complex intervention or the cost of genetic testing for Alzheimer’s. The costs for adhering to this protocol would quickly add up, but the descriptions are so vague that it’s impossible to make informed projections. It cites “diet, brain stimulation, exercise, pharmaceuticals, optimization of sleep, specific pharmaceuticals and vitamins,and multiple additional steps that affect brain chemistry.”

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The research consists of 10 case studies in which all subjects showed some degree of improvement. But the news release gives information about only three patients — out of 10 in the study — who had the most dramatic improvements.It relates those patients’ self-reported advances in functionality and gives measurements in memory improvement for two patients. It does not warn that self-reported improvements are likely to be biased by the patient’s expectation of benefit from the program. It does not describe the specific interventions used for each patient. The news release doesn’t tell us the total number of patients that were enrolled in this protocol. Were only the 10 that showed improvement included in the case study? What about the rest?

The release appears to cherry pick some data regarding risks and uses relative risks only, no absolute numbers. For example, you cannot tell from this release what your chances are of getting Alzheimer’s if you have one or two APOE genes.

Claims found in the release such as “Follow up testing showed some of the patients going from abnormal to normal” are both grandiose and unsubstantiated, but they could raise patient and caregivers’ hopes that they or a loved one could reverse their Alzheimer’s symptoms.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The news release does not mention any potential risks of any aspect of the protocol. Since we do not really know what the protocol consists of we have no way of assessing potential risk.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

Neither the news release nor the study explain how the patients were selected, or whether there were any drop-outs. It would be useful to know whether participants had a previously demonstrated ability to adhere to treatment protocols or family support that would help them stick to the intensive MEND regimen. The news release does not mention that at least one patient dropped out temporarily, raising a concern that the program, which is complex and requires many lifestyle changes, may be difficult for some patients to follow. The news release also doesn’t point out that it’s unknown how long observed improvements will be maintained.

The program as a whole has yet to be proven effective and safe in a broad population. The news release acknowledges this fact with a quote from Bredesen: “Even though we see the far-reaching implications of this success, we also realize that this is a very small study that needs to be replicated in larger numbers at various sites.” It would be difficult to perform a rigorous clinical trial on this protocol since it’s reportedly tailored to each patient and involves 36 potential interventions. Clinical trials usually test only one treatment at a time, preferably comparing it to a placebo.

Does the news release commit disease-mongering?

Not Satisfactory

The news release points out the vast and growing number of Alzheimer’s cases. But it edges toward disease-mongering when it quotes a researcher suggesting the protocol can “transform the perception and reality of Alzheimer’s disease from a death sentence to a preventable reversible condition.”

It also recommends genetic testing for everyone, which clearly is not appropriate or warranted. The release states, “Now we’re recommending that people find out their genetic status as early as possible so they can go on prevention.”

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The news release notes that the National Institutes of Health (NIH) provided some funding, but it does not list all of the study’s funding sources. Those include the Accelerate Fund, an early-stage investment fund based in Canada. The researcher also apparently stands to benefit from sales of a book set to be released in May 2017 through a mainstream book publisher.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The news release gives the briefest nod to an alternative, stating that the protocol to reverse memory loss “follows the abject failure” of single-drug therapies for Alzheimer’s. In reality, many interventions, not only drugs, have been tried and none have been found to work.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Some of the MEND interventions, such as dietary changes and exercise, may be readily available. But the intensiveness that this approach requires would make it hard for most people to access financially and logistically. Perhaps the book about the program, when it publishes, will make this clear, but the news release does not.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The news release claims that the research “is the first to objectively show that memory loss in patients can be reversed, and improvement sustained” using the complex protocol. We rate this unsatisfactory since the release implies throughout that the protocol can reverse memory loss in Alzheimer’s patients when that is not indicated by the limited evidence.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

There are several instances of unjustifiable language in the news release, given the fact that this was an uncontrolled 10-person study. Some examples:

“The magnitude of improvement in these ten patients is unprecedented”

“Transform the perception and reality of Alzheimer’s disease from a death sentence to a preventable reversible condition”

“Now we’re recommending that people find out their genetic status as early as possible so they can go on prevention.”

Total Score: 1 of 10 Satisfactory

Comments (1)

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Denise DeGrazia

June 22, 2016 at 1:50 pm

Thank you for calling this out. I hate these kinds of so called “breakthrough” treatments based on a handful of patients. Giving people false hope. Really ticks me off.

Reply