A New Clinical Trial of a Red Wine Derivative
By Judith Neugroschl, M.D.

The Mount Sinai ADRC is excited to announce our participation in a new nationwide study examining the effect of resveratrol in patients with mild to moderate Alzheimer’s disease (AD).  What makes this trial unique is that in addition to the traditional paper and pencil tests, the effects of this medication will be evaluated using MRIs (to assess the size of various areas of the brain), as well as biological markers found in the cerebro-spinal fluid (CSF) that are thought to correlate with AD. CSF is a fluid that surrounds the brain and spinal cord; one function of the CSF is to protect these areas from injury. CSF is collected using a procedure called a lumbar puncture (or “spinal tap”) — in which a needle is inserted into the lower back and a small amount of the fluid is removed for testing. CSF collection is quickly becoming a standard part of research, as it is the most reliable source for measuring brain metabolism and function.
Resveratrol is derived from plants and is found in high levels in certain red wines and the skin of red grapes. You may have heard that drinking one glass of red wine a day is beneficial for your memory. There is some evidence to suggest that resveratrol is the reason for this potential benefit.
It appears that resveratrol may have several mechanisms of action related to the development of AD. In the lab, resveratrol protects cells against Abeta/amyloid-induced injury to brain cells. Abeta is a peptide that can clump together to form amyloid plaques in the brain, which is one of the hallmarks of AD.  Furthermore, in the lab, resveratrol lowers the levels of Abeta produced from different types of cells. It also appears to help in the breakdown of Abeta.  In mice, resveratrol decreased the amount of amyloid plaque in the brain.  Resveratrol is also involved in genetic regulation of the aging process, such that it mimics a protein that is known to prolong the lifespan of an organism. Together, these results are promising; however, a large scale clinical trial examining resveratrol’s potential benefits in people with AD is critically important.
The drug has been tested in healthy men using a single oral dose of up to 1000mg.  It is commercially available in doses up to 700mg, although the actual amount of resveratrol in commercial formulations is unknown, as it is not regulated.  In general, it is categorized as “generally recognized as safe” by the U.S. FDA and the FDA is currently reviewing the study protocol to evaluate the proposed doses. 
There was a pilot study examining the effects of
resveratrol at Mount Sinai. However, the pilot study used a much lower dose of resveratrol than what is planned for the new study. Results of the pilot study are almost ready to be analyzed.
The upcoming Resveratrol study will take place over one year, and will require 10 visits, including two lumbar punctures and three MRIs. This study will evaluate resveratrol’s effect on biomarkers of AD, as well as resveratrol’s effect on brain atrophy. We are excited to be taking part in this study. For more information, please contact Helene Geramian at 212-659-8885.

Caregiver’s Corner

Support Groups For information about our Spanish Groups, please see page
Early-stage-dementia support group— This is a bimonthly support group for caregivers of individuals with early stage dementia. The group meets on Wednesdays at the Martha Stewart Center for Living at Mount Sinai and is lead by Elizabeth Fine, M.S.W. For more information, please call 212-659-9230.
The Memory Tree by DOROT— This is a unique program that offers programs for individuals with mild Alzheimer’s disease, as well as their family and caregivers. For more information, please visit http://www.thememorytree.org or contact Elizabeth Fine, M.S.W at 917-656-0558.

Resources for Patients and Caregivers
Safe Return Bracelet — The MedicAlert + Safe Return program work in tandem to ensure that lost or separated individuals are reunited with their families. To register a loved one call 800-272-3900.
Jitterbug cell phone—This is a simple and affordable cell phone especially made for seniors. For more information call 888-824-1895.
This Caring Home — An interactive website with information and tips to make the home safer for individuals with Alzheimer’s disease. http://www.thiscaringhome.org/
Medical Alert Service — Lifeline is a service that with the push of a button can alert appropriate individuals in case of a medical emergency. Some models automatically call for help when it detects that the person has fallen. To register for their services or obtain more information, call 800-566-6218.
Meals on Wheels — An organization comprised of local and community-based nutritional programs which provides meals to seniors. There are several participating centers in the NYC area. To find a local program, visit http://www.mowaa.org.
Alzheimer’s Disease Education and Referral (ADEAR) — A comprehensive website with AD information and resources from the National Institute on Aging. http://www.nia.nih.gov/Alzheimers/
Mount Sinai ADRC — Our website is an all encompassing tool containing information about AD, our research programs, as well as resources for caregivers. You can also find previous editions of our newsletter here. www.mssm.edu/adrc

Memory Enhancement Tip…
By Margaret Sewell, Ph.D.

Although it may seem simple, a major memory culprit in healthy elders is a failure to pay attention. As individuals living in the 21st century, we are continuously bombarded by a slew of information- what some may call information overload. However, there are simple techniques that can be employed in order to best attend to (and remember!) the details of our daily lives.
Some suggestions:
Slow Down: By slowing down, the mind has more time to process what you are experiencing, which makes for a better “memory imprint”.
Focus: Concentration is key to memory enhancement.
Rehearse the information out loud: By vocalizing what you wish to remember, you allow yourself another opportunity to encode information.
So next time you need to remember a book club book, try summarizing a chapter out loud. Need to remember where you parked your car? Take a moment to repeat the level or number to yourself. Learn the name of a new friend? Pause and match the name to the face. You’d be surprised what a difference focus can make!

Results: Home-Based Assessment Study
By Mary Sano, Ph.D.
The Mount Sinai ADRC community, under the leadership of Jane Martin, Ph.D., is a strong participator in the Home-Based Assessment (HBA) Study, in which healthy seniors complete evaluations in their home. This is the first study of its kind, comparing traditional testing with automated telephone testing or computerized testing. It is also unique in that it will continue for four years. The results of the initial participant selection and evaluation were presented at the Alzheimer Association International Congress by Mary Sano, Ph.D., which was held in Paris this past June; Dr. Sano is the national director for the study. Several interesting results were reported. Overall, individuals were generally willing to participate in all arms (i.e., telephone, traditional, or computerized testing) regardless of age, education or general health. This suggests that many people are open to trying new technologies. However, there seems to be a preference for less frequent assessment and for technologies that used more traditional equipment, such as telephones. We want to thank all of our volunteers and ask them to “stay the course” to finish this important four year project.

Participant Appreciation Day
The Alzheimer’s Disease Research Center (ADRC) hosted its fourth annual Participant Appreciation Day on May 11, 2011. Our staff was joined by 58 participants and caregivers. Following a warm welcome by Margaret Sewell, Ph.D., presentations included information about genetics, new treatment approaches, and the experience of participating in a clinical research trial. Sam Gandy, M.D., Ph.D., the Associate Director of the ADRC, discussed the process of developing new medications. Gregory Elder, M.D., reviewed what genetic studies have told us about Alzheimer’s disease. Mary Sano, Ph.D., the Director of the ADRC, delved into the benefits of participating in research. Information about our current clinical research trials was presented by Hillel Grossman, M.D., and Judith Neugroschl, M.D. In addition, Laurel Humble, from the Museum of Modern Art (MoMA), joined us for a presentation about the Art and Dementia Program at the MoMA. She also conducted a break-out session where participants created personal masterpieces from paper cut-outs. Meanwhile, Elizabeth Fine, MSW, informed caregivers on various sources of support.

In the news…

Does moderate drinking help prevent Alzheimer’s disease? A recent review of research regarding alcohol consumption and dementia indicates that drinking moderate amounts of alcohol, especially wine, may lower the risk of dementia. The review of 143 studies demonstrated that individuals who drank moderately were in fact 23% less likely to develop dementia, including Alzheimer’s disease and other forms of cognitive impairment; wine may be slightly more beneficial than beer. On the other hand, heavy drinking, which constitutes more than three to five drinks per day, was found to be associated with an increased risk of cognitive impairment and dementia. Although there are several reports of the beneficial effects of alcohol, Sam Gandy, M.D., Ph.D, associate director of the ADRC, cautions against individuals using alcohol as an approach to prevent cognitive decline, as there have been no clinical trials examining the relationship between moderate alcohol consumption and cognitive health.

Doctors Debate Effectiveness of Alzheimer’s “Milkshake”. Axona is a controversial new alternative treatment for Alzheimer’s disease. Axona is considered to be “medical food,” not a drug, that supplies the brain with fats and ketones, which are to be used as fuel. Although some people are hopeful about alternative treatments, such as Axona, many researchers, including Sam Gandy, M.D., Ph.D, are less optimistic about these products. “It’s fairly outrageous that little can be done to impede the exploitative marketing of unproven and unlikely substances to vulnerable Alzheimer’s patients and their desperate caregivers,” says Dr. Gandy. A major concern among critics is the lack of data showing that the “medical food” is beneficial.

FAQ: Lumbar punctures (LP)
How long does it take? The LP takes approximately 20 to 30 minutes, with an additional 30 minutes to rest after the procedure.
Does it hurt? You can expect pressure when the needle is inserted and may experience brief leg pain while the needle is positioned.
Can I be paralyzed if the needle hits the spinal cord? No. The needle is inserted below the spinal cord. There is no risk of paralysis.
What are the side effects of a LP? During the procedure, you may have temporary back pain and/or discomfort. After the procedure, you may have a headache. There are other side-effects that are uncommon, which our physician can discuss with you.
How is the lumbar puncture performed? You will either lie on your side, with your knees drawn up or you will sit on the edge of the exam table. A local anesthetic may be given at the puncture site. A needle is inserted into your back to collect the spinal fluid.

For more information about lumbar punctures, please contact us at 212-241-8329. We can arrange an appointment with one of our physicians. We also have informational videos about the procedure that you may borrow or you can visit http://www.adcs.org/Research/LPVideo.aspx.

Mount Sinai Clinical Research Day
On Wednesday September 21st, members of the ADRC participated in “Clinical Research Day”, hosted by the Mount Sinai School of Medicine. Situated in the bustling first floor of the hospital, investigators and coordinators from various departments of Mount Sinai had the opportunity to showcase their research projects, engage with potential participants and meet other members of the Mount Sinai research community. The ADRC proudly displayed results from closed clinical trials as well as information related to new programs. The event provided a unique opportunity to share a love of science with peers and passerbys alike.

Mount Sinai joined forces with other ADRCs in NYC as part of NYCARE for the
23rd Annual Memory Walk
on
Sunday, October 23, 2011
Riverside Park

Through generous donations from our family, friends, and supporters, we were able to reach our
fundraising goal! So far, we have raised over $10,000!!

Haven’t made a contribution? It’s never too late!
Visit our team page at: http://walktoendalz.kintera.org/nyc/mountsinai

We hope you join our team next year.

Nuevo proyecto de investigación evalúa un derivado del vino tinto para combatir la Enfermedad de Alzheimer
By Judith Neugroschl, M.D.

El Centro de Investigación de la Enfermedad de Alzheimer’s o ADRC, por sus siglas en ingles, del “Mount Sinai School of Medicine,” se complace en anunciar que formará parte de un estudio a nivel nacional con el objetivo de examinar el efecto de “resveratrol” en las etapas leves o moderadas de esta enfermedad. El estudio evaluará los efectos del “resveratrol” en los marcadores biológicos y en las áreas del cerebro con evidencia de atrofio. Además examinará si esta sustancia es segura y tolerable en pacientes mayores de 50 años en las etapas moderadas o leves de la EA.
El ensayo clínico se distingue de manera singular ya que además de utilizar instrumentos de investigación tradicionales, tales como exámenes en papel y lápiz, utilizará pruebas de resonancia magnética para explorar el efecto de “resveratrol” en el cerebro. A través de pruebas de resonancia magnética, o MRI , se podrá observar el tamaño de áreas en el cerebro. Pruebas adicionales se utilizarán para determinar la presencia de marcadores biológicos correlacionados con la EA en el líquido cefalorraquídeo (LCR).
El LCR es el líquido que rodea y protege el cerebro y la médula espinal. El LCR se obtiene a través de una prueba conocida como “punción lumbar” que consiste en introducir una aguja en la parta baja de la espalda para extraer una pequeña cantidad de líquido. El LCR se observa y evalúa en el laboratorio y es una fuente de información confiable para medir el metabolismo y funcionamiento del cerebro. Es por esta razón que el uso del LCR en la investigación médica se ha convertido en una práctica de rutina.
El “resveratrol” es una sustancia derivada de plantas que se encuentra en algunas clases de vino tinto y en la piel o cáscara de la uva roja. Se piensa que el “resveratrol” posee varios mecanismos de acción relacionados al desarrollo de la EA y es por esto que puede que usted haya escuchado decir que el consumir una copa o un vaso de vino tinto al día es de beneficio para la memoria.
En exámenes de laboratorio se ha encontrado que el “resveratrol” protege las células cerebrales contra los daños causados por el “Abeta/amyloid.” El Abeta es un péptido que tiene la capacidad de agruparse para formar placas amiloideas en las células del cerebro, uno de los mecanismos que se piensa que puede ser la causa de la EA. En el laboratorio el “resveratrol” disminuye los niveles de Abeta producidos por diferentes tipos de células, y facilita su desintegración. En pruebas de laboratorio, llevadas a cabo con ratones, el “resveratrol” también disminuye la cantidad de placas amiloideas en el cerebro. El “resveratrol” además está asociado a la regulación genética del proceso de envejecimiento, tanto así que mimetiza una proteína que se distingue por alargar las expectativas de vida de un organismo. En conjunto estos resultados son prometedores, pero es de gran importancia el desarrollar un ensayo clínico a gran escala para determinar el beneficio de esta sustancia en las personas con EA.
El “resveratrol” esta disponible comercialmente en dosis de hasta 700 mg. y se ha evaluado en hombres saludables en dosis de hasta 1000 mg. El contenido específico en las formulaciones comerciales no se conoce ya que todavía no existen políticas de control. Hasta ahora el “FDA” o Administración de Alimentos y Drogas de los EEUU, ha determinado que es una sustancia segura. Actualmente esta agencia federal lleva a cabo una evaluación con el fin de emitir recomendaciones acerca de las dosis propuestas para uso. En un estudio piloto, que se llevo a cabo en el “Mount Sinai School of Medicine” se utilizaron dosis mucho menores y los resultados están en proceso de análisis.
El proyecto de investigación que describimos actualmente se llevará acabo durante un periodo de 52 semanas. Los participantes realizarán10 visitas a la clínica y se someterán a 2 exámenes de punción lumbar y a 3 exámenes de resonancia magnética.
El proyecto de investigación, como dijimos anteriormente, tiene el objetivo de evaluar los efectos del “resveratrol” en los marcadores biológicos y en las áreas del cerebro con evidencia de atrofio. Además este proyecto tiene el objetivo de examinar con mas precisión si esta sustancia es segura y tolerable en pacientes mayores de 50 años durante las etapas moderada o leve de la enfermedad.
Para más información sobre este estudio por favor contacte a Helene Geramian al 212-659-8885.