The notion of using food to treat or prevent disease dates to ancient times of more than 5,000 years ago in Indian traditions and can be traced through the writings of Hippocrates, the father of Western medicine. The interest remains strong, with evidence that more than a third of adults in the U.S. are using some form of  alternative treatments for health problems.

Medical Foods are a modern example of products intended for the specific dietary management of a disease or condition that has distinctive nutritional requirements. In 1988, Medical Foods were regulated by the FDA as part of the Orphan Drug Act.  Unlike FDA-approved drugs, which undergo testing in patients to assure they are effective, these products submit health claims to the FDA based on a theory of how the food works. The manufacturer does not have to prove that there is a benefit in patients, however the food must be made of ingredients that are “generally regarded as safe” (GRAS), and the food must be prepared under “good manufacturing practice.”

There are two medical foods that are currently targeted toward Alzheimer disease (AD). One, Axona, became available as a prescription supplement in 2009, claiming to target the nutritional needs of people with AD. Specifically, it has been proposed that AD hinders the brain’s ability to break down glucose, and

Axona may provide an alternative source of glucose that the brain can use for energy.

Non-pharmalogic therapy (NPT) is a term that encompasses a wide variety of non-drug interventions for Alzheimer’s disease (AD) patients and their caregivers. Many NPT’s are intended to complement the use of standard dementia medications.

Like pharmacological therapies, NPTs for Alzheimer’s disease can focus on behavioral or cognitive outcomes as well as economic or quality of life effects. NPT may be conducted in the community or in residences and nursing homes.  NPTs often use person-centered approaches that focus on understanding the patient’s experience of dementia and dementia-related symptoms. NPTs may also be aimed at caregivers and include caregiver education, skills training, counseling, respite care, and social support. While these may reduce caregiver burden, many also improve outcomes for the patient. A comprehensive list is beyond the scope of this article, but commonly described therapies include behavioral therapy, art and music therapy, spaced-retrieval training (where patients are trained to remember simple tasks over longer periods of time), cognitive stimulation and training, reality orientation therapy, pet therapy, and physical exercise programs.

Determining if NPTs work is confusing and made more difficult by the limited amount of well conducted research. Compared to medication therapies, there is less research for NPTs. A review of AD/MCI studies listed on the website ClinicalTrials.gov indicated only 24 of 256 studies were specifically non-pharmacologic. Probably less research funding is possible for the lack of high quality randomized controlled trials of NPTs. Many NPT studies have significant limitations including: small sample sizes, positive findings that have not been replicated, small magnitudes of change that do not generalize to daily life, and results that do not last over time. These limitations make it difficult to interpret the results.

Even among well-conducted studies that assess substantial or sustained memory improvement, results are disappointing. In a review of the effectiveness of NPTs in AD, Resiberg et al described research on behavioral interventions, cognitive stimulation, music and art programs and physical exercise.

We are proud to announce that Mount Sinai Medical Center is the first in the tri-state area to use the newly approved imaging technique to detect

Alzheimer’s disease (AD) pathology in people who are cognitively impaired. This new technique uses a radioactive agent called florbetapir (trade name Amyvid), which can be administered through injection in the arm. Florbetapir binds to amyloid plaques in the brain that are highlighted so they can be seen in a positron emission tomography (PET) scan. Amyloid plaques are the hallmark pathology in the brains of those with AD. The scan can be used in two ways. A negative scan indicates the absence of plaques and a low likelihood of AD. In those who have cognitive problems, a positive scan indicates plaques are likely to be present and the diagnosis may include AD. However, other conditions may also be present. The scan is not currently covered by health insurance but over time if it proves to be useful in diagnosis, it may become part of reimbursed services.

Not pictured: ADRC Intern  Michael Kahen and volunteer Julia Strauss

Finally,  Dr. Grossman, Education Core co-director Judith Neugroschl, M.D. and ADRC Associate Director Samuel Gandy, M.D., Ph.D. in a panel discussion of “What’s next: New and novel ideas in dementia research.” Because of the recent press release announcing FDA approval of the new diagnostic PET scan agent Amyvid, there were many audience questions about Amyvid and what its approval means. (Thanks to your feedback on that day, we have expanded on this topic on page 2) We asked the audience to answer this question: “Dr. Sano spoke of the new PET scan that can detect beta-amyloid in the brain.  If you could find out if you had beta-amyloid in your brain, would you want to know?” to which 34 of you answered yes and 7 answered no.  We offer our heartfelt thanks to all the families who give so much to the fight against Alzheimer’s. We look forward to seeing you next year!

My friend Mitch had been involved in research at the James J. Peter VA Medical Center and found out about the studies being done at Mount Sinai. So we came in as a team and were asked to take part in the program, which includes brain studies and verbal tests for memory, and the idea made a lot of sense to both of us.

Q:  Tell us  about your experience as a research participant.

I am very impressed by the professionalism and competence of the ADRC staff, as they have been supportive and helpful every step of the way. Staff members have scheduled appointments with our needs in mind and have made reminder calls. Coordinators are knowledgeable, polite, and respectful of our concerns.

Q:  You had a spinal tap performed. Were you comfortable having this procedure?

What got me feeling confident was the stated assurance that this procedure poses no risk of paralysis. I understood that the neurologist, Dr. Goldstein, who performed the spinal tap, was a highly qualified and experienced physician. I was further reassured by Mt. Sinai’s excellent reputation and by the fact that the hospital would handle any problems that might arise. Additionally, arrangements were made to make the experience as comfortable and convenient as possible.

Q:  Was the spinal tap painful?

No. What was unpleasant was the awkward “fetal” position I had to maintain—sitting on the side of the bed, my back stretching forward, my face resting on two pillows in my lap. The procedure took around 45 minutes. Dr. Goldstein explained that he could speed it up by using a bigger needle. But the larger the needle, the more likely I would be to have a headache afterward. Understanding the reason for going slow gave me the patience to remain still for the duration.

Q:  Would you recommend research participation to others?

Yes. Taking part in an investigation of the mental and physical factors that may help researchers identify the causes and early symptoms of Alzheimer’s, and its treatment, is a way of contributing to society. As Alzheimer’s is a dreadful disease, it is important for all of us to help with research, and I would certainly recommend participating with the ADRC to anyone interested in this field of research.

• Gammagard’s IGIV treatment: One clinician found that his four patients receiving the study drug showed improvement. This information was primary data released of four individuals who demonstrated 3 years of stable cognition during their participation. Nurses’ Health Study on sleep disorders and lower cognition: The study explored if sleeping too much or too little could lead to lowered cognition and demonstrated that people whose sleep changed significantly – either increasing or decreasing by 2 hours- had increased risk of cognitive decline.
• Swiss study on the relationship between stride speed and variability and cognitive impairment: The study found that in people with worse cognitive decline, gait was slower than in those with less severe cognitive concerns. In addition, specific parts of walking were observed – for example, information processing speed was associated with the rhythm aspect of gait (stride time and cadence).
• University of California – San Francisco study on alcohol use and MCI: The study followed elderly women over 20 years who continued to drink 7-14 drinks per week as they aged or those who started later in life. The data indicated possible increased risk of cognitive decline in late-life binge drinkers as well as increased risk of mild cognitive impairment. They also found that sleep apnea was associated with greater risk of MCI.

The cancer drug you may have heard about in the news is called Bexarotene and indeed, it is US Federal Drug Administration (FDA) – approved to treat certain cancers. However, as with all new drugs, the FDA needs more information about the safety of this drug – for example, what are the side effects? Does it actually work? There are currently a few different research groups looking into Bexarotene as a treatment for AD. So far, nobody has been able to confirm that this drug is safe and effective in treating Alzheimer’s disease. In fact, even the effectiveness in mouse models of AD has not yet been confirmed. Until this is done, no doctors should be prescribing this drug “off label” for treatment of AD. We’ll be sure to keep you posted if there is news about this!

Q: There was a lot of media coverage in July, 2012, concerning off label use of IVIg for Alzheimer’s. How can I learn more about this therapy?

Among off label drugs, the one in widest use (which amounts to a few dozen patients who have the resources to afford it) is IVIg, which costs $4,000-$5,000 each month. A study with 300 subjects is underway and the results will be available next year. If that study confirms the benefit of IVIg and the FDA approves its use for AD, then Medicare and insurance is likely to begin reimbursing so that everyone can gain access to the drug.

Q: Does the generic version of Aricept work as well as the regular one?

The active ingredient in the generic version of Aricept, known as donepezil, is identical to the active ingredient in the trademarked version. Some differences in formulation can sometimes change effects of generic medications, but, so far, no problems with generic donepezil have been reported. This is something that has doctors on the alert and we will let our readers know if any reports appear that suggest any problems with generic donepezil.

Q: I’ve heard coconut oil cures dementia. Is that true?

This came up during our recent Participant Appreciation Day but it’s worth revisiting. Unfortunately, it is simply a rumor; allegedly, a woman reported that coconut oil reversed her husband’s dementia. Nobody seems to know her name, and there is currently no evidence showing that coconut oil can improve patients with dementia. The popularity of this rumor reflects the public’s interest in non-drug preventions and treatments of Alzheimer’s disease. In fact, we have a clinical trial at our center that is looking at the anti-oxidant found in red wine and grapes, called Resveratrol, and if it is helpful to those living with AD. We have no plans to look into coconut oil, however! The best lifestyle modification that everyone can do to delay, prevent or slow progression of AD is regular vigorous exercise for at least three 30-minute sessions each week.