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Wednesday, July 28, 2010

Detecting Memory Impairment Earlier


Readers,

One of the constant challenges in the field of Alzheimer's disease is that the illness is routinely detected too late in today's medical environment. The data show that diagnoses are most common in years 8-10 of a typical disease course that runs 14 years. This means that the opportunity for early treatment, when the brain is still quite healthy, is very difficult to achieve.

Beginning in January of 2011, however, Medicare will reimburse primary care physicians to perform a more complete "Welcome to Medicare" visit with newly eligible members. They will also pay physicians to perform a complete "Wellness Visit" on an annual basis. Both the welcome visit and the wellness visit will include "detection of cognitive impairment". This is an important provision that calls for cognitive impairment screening for Medicare beneficiaries under the healthcare reform proposal, "America's Healthy Future Act of 2009."

This is a great step in the right direction. It will force a conversation between patients and doctors that has been sorely needed but ignored for some time. It will likely lead to a scenario where the informed physician will find and treat a range of memory-impairing medical problems from depression to thyroid disorder to early Alzheimer's disease.

Michael Rafii, MD, PhD
Associate Medical Core Director, ADCS
 
Author: Michael Rafii MD, PhD at 1:24 PM 0 Comments

Monday, July 26, 2010

Women and Alzheimer's Disease


Dear Readers,

Welcome to Checking in from the "Field" with Dr. A., a new monthly blog post on Alzheimer's Insights. For the last 14 years, in addition to evaluating patients at the Rush Memory Clinic, I have been the "MD in the Field" for many of our community based participatory research studies conducted at the Rush Alzheimer's Disease Center and the Rush Institute for Aging in Chicago, Illinois.

Over the years performing study related home visits or community presentations, I have been asked by study participants, their family members and neighbors, to provide comments and interpretations on the latest "memory” and Alzheimer's disease (AD) research studies on women and minorities.

In this monthly blog post, I will focus on (1) women and minority specific health issues as they relate to cognitive health and Alzheimer's disease, (2) answer questions that are routinely asked of me by patients and community study participants about their cognitive concerns, and (3) highlight the latest cognitive and AD research findings on women and minorities. In keeping with the goals for the ADCS blog, I aim to provide these specific updates in understandable language. Today's post will focus on Women and Alzheimer's disease.

It is rare that a day in the field goes by without a woman participant or family member asking me about the latest in "memory” research as it relates to women. The specific question is: "Do women get Alzheimer's disease more than men?" I don't find this question surprising as the majority of clinical patients I diagnose with AD, or examine in our clinical trials or cognitive research studies, "just happen" to be women. So, here are a few general facts that you may want to remember the next time you read or hear about research regarding Women and Alzheimer's disease.

1) The population is aging in the US (and across most of the world) with dementia rates doubling every 5 years after the age of 65. The most rapid increase will be in those over 85 years of age, a group that is commonly called the "oldest old". It is projected based on these trends that the occurrence of AD dementia will increase- nearly tripling by 2050.

2) The average life expectancy is longer for women than men. According to the U.S. Centers for Disease Control and Prevention, a girl born in 2005 is expected to live to age 80, compared to 75 for a boy. Therefore, there will be a higher proportion of women in this oldest age group and these women will be at a much higher risk for developing AD dementia.

3) Cardiovascular risk factors have been associated with increased likelihood of developing dementia and AD. Recent studies are showing that more women than men struggle with some cardiovascular risk factors, such as obesity, diabetes in addition to hypertension (HTN). For example, the prevalence of HTN is greater in men than in women until age 60, but after age 60, it becomes higher in women. In addition, diabetes, which is increasing in frequency in women compared to men, has been associated with poorer cognitive function and greater decline in those over 65 making women more vulnerable to the development dementia.
4) The debate continues regarding hormone replacement therapy (estrogen) for the prevention of AD dementia. Some studies have found that women who used estrogen hormone therapy before the age of 65 could cut their risk of developing dementia or AD dementia, whereas other studies have suggested that hormone replacement therapy can increase a person's risk of developing dementia. At this point, most researchers do not believe that there is enough evidence to warrant prescribing estrogen for the prevention of dementia.
5) And last but not least, we must consider "genes". A recent study showed that a gene variant on the X chromosome may be related to an increased risk of developing AD dementia. Indeed, both women and men with one variant of the gene were at risk, however interestingly, the risk was more pronounced in women with the variant on both X chromosomes. This study is intriguing and more studies are needed to determine just how "big of a risk" it is to have this variant.

Neelum T. Aggarwal, MD
Steering Committee Member, ADCS
Associate Professor of Neurological Sciences- Rush University Medical Center
Rush Alzheimer's Disease Center and Rush Institute for Healthy Aging

References:

www.nia.nih.gov
www.alz.org

Kearney PM, Whelton M, Reynolds N et al. Global burden of hypertension: analysis of worldwide data. Lancet 2005; 365(9455):217-23.
Sowers, JR. Diabetes in elderly and in women: cardiovascular risks. Cardiol Clin 2004; 22:541-51.
Henderson V Aging, estrogens, and episodic memory in women. Cogn Behav Neurol. 2009 Dec; 22(4):205-14.
Crrasquillo MM, Zou F, Pankratz VS et al. Genetic variation in PCDH11X is associated with susceptibility to late-onset Alzheimer's disease Nat Genet. 2009 Feb;41(2):192-8.
 
Author: Neelum Aggarwal MD at 5:00 PM 0 Comments

Wednesday, July 21, 2010

Vitamin D and Cognitive Health


Readers,

Another important finding from the ICAD meeting last week revolves around the relationship between cognitive decline and vitamin D.

Several high-profile studies have suggested that high levels of vitamin D lower the risk of developing multiple sclerosis and accumulating evidence suggests previously unsuspected roles for vitamin D in brain development and neuroprotection.

Now, a new study shows that low Vitamin D levels may be related to cognitive decline and dementia. Researchers have in fact found a link between vitamin D deficiency and increased risk of cognitive impairment and dementia later in life. The researchers analyzed data from 3,325 people aged 65 and older who have lived in Tuscany, Italy over the period of six years. The participants' vitamin D levels were measured from blood samples and compared with their performance on a measure of cognitive function that included tests of memory, orientation in time and space, and ability to maintain attention. Those who scored in the lowest 10 percent were classified as being cognitively impaired. The study found that the risk of cognitive impairment was 42 percent higher in people who were deficient in vitamin D, and 394 percent higher in those with severe vitamin D deficiency. This association remained after adjusting for potential confounders.

If future studies and randomized controlled trials confirm that vitamin D deficiency is causally related to cognitive decline, this would open up important new possibilities for treatment and prevention.

Michael Rafii, MD, PhD
Associate Medical Core Director, ADCS

Llewellyn DJ et al, Vitamin D and risk of cognitive decline in elderly persons. Arch Intern Med. 2010 Jul 12; 170(13):1135-41.

 
Author: Michael Rafii MD, PhD at 11:28 AM 0 Comments

Wednesday, July 14, 2010

Changing the Criteria for Diagnosing Alzheimer's


Readers,

Below is the first of a series of upcoming blogs reporting the news from ICAD, the International Conference on AD taking place this week in Hawaii.

For the first time in 25 years, there is a proposal to change the criteria for Alzheimer’s disease, part of a new movement to diagnose and, eventually, treat the disease earlier. As readers will recall, Alzheimer's is thought to begin years, perhaps even decades, before symptoms are noticeable. But there is no single, generally accepted way to identify the disease in its earliest stages – before symptoms are evident. The new diagnostic guidelines, presented yesterday, would mean that new technology such as brain scans would be used to detect the disease even before there are evident memory problems or other symptoms.

Development of the guidelines, by panels of experts convened by the National Institute on Aging and the Alzheimer’s Association, began a year ago because, with a new understanding of the disease and new ways of detection, it was becoming clear that the old method of diagnosing Alzheimer’s was quite outdated.

The current formal criteria for diagnosing Alzheimer’s require steadily progressing dementia — memory loss and an inability to carry out day-to-day activities, like dressing or bathing — along with a pathologist’s report of plaques and tangles in the brain after death.

The new guidelines include criteria for three stages of the disease: preclinical disease, mild cognitive impairment due to Alzheimer’s disease and, lastly, Alzheimer’s dementia. Under the new guidelines, for the first time, diagnoses will aim to identify the disease as it is developing by using results from so-called biomarkers — tests like brain PET scans, MRI scans and spinal taps that reveal telltale brain changes seen in early AD.

Michael Rafii, MD, PhD
Associate Medical Director, ADCS
 
Author: Michael Rafii MD, PhD at 12:49 PM 0 Comments

Wednesday, July 07, 2010

How Drugs are Approved



Patients often ask how drugs are selected by the FDA for use in different diseases. Below is a brief review of the process that is used to evaluate and test drugs that may benefit patients.

Before a drug can be approved for use by patients, there is a set of clinical tests that must be performed. This is the Pre-Clinical Research Stage, where extensive animal tests are performed on dosing and side effects. Institutional and safety review boards assess the studies and make recommendations on how to proceed. If the recommendations are positive, then an application to the FDA occurs and clinical tests in humans may begin.

Phase 1: Clinical studies in this phase represent the first time that an Investigational New Drug (IND) is tested on humans, either healthy volunteers or patients. The purpose of these studies is to look at the metabolism and any potential side effects of the drug in humans. Phase 1 studies are usually conducted on 20 to 80 subjects and are therefore concerned with safety and tolerability.

Phase 2: The purpose of phase 2 is to determine the efficacy of a drug to treat patients with a specific disease or condition, as well as learn about common short-term side effects or risks. These studies are conducted on a larger scale than phase 1 studies and typically involve several hundred patients.
Phase 3: These trials provide even more information about the effects and safety of the drug, and more importantly assess the efficacy or the drug’s ability to treat the disease. Phase 3 studies generally involve several hundred to several thousand people and can last from months to a couple of years. These trials are almost always double-blind and placebo controlled. This means that neither the subjects nor the researchers know who is getting the investigational drug versus placebo (or sugar pill).

There are several checks and balances in the process of clinical trials; among them are the use of Institutional Review Boards (IRBs), Data Safety Monitoring Boards (DSMBs), and other advisory committees. IRBs are designed to protect the rights and welfare of people participating in clinical trials both before and during the trials. IRBs are made up of a group of at least five experts and lay people with diverse backgrounds to provide a complete review of clinical proceedings. Also, clinical trials are monitored for their entire duration by study monitors and safety monitoring boards that follow subjects in real time as trials progress.

Once a trial is complete, or closed, the data is then analyzed by statisticians and researchers to look for efficacy. Since many trials are multi-center, this process can take many months, the results of which are eventually submitted in a formal application to the FDA for final approval. This New Drug Application (NDA) must include results and analyses from all tests of the drug on both animals and humans. The NDA must provide enough detailed information for FDA reviewers to make several critical decisions. The result of the study must show whether the drug is safe and effective and whether its benefits outweigh its risks.
The process of developing and testing a new drug is a lengthy one. The FDA estimates that it takes a little over 8 years to test a drug, including early laboratory and animal testing, before there is final approval for use by patients.



Michael Rafii, MD, PhD
Associate Medical Director, ADCS
 
Author: Michael Rafii MD, PhD at 10:57 AM 0 Comments

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The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a major initiative for Alzheimer's disease (AD) clinical studies in the Federal government, addressing treatments for both cognitive and behavioral symptoms. This is part of the NIA Division of Neuroscience's effort to facilitate the discovery, development and testing of new drugs for the treatment of AD and also is part of the Alzheimer's Disease Prevention Initiative.

The ADCS was developed in response to a perceived need to advance research in the development of drugs that might be useful for treating patients with Alzheimer's disease (AD), particularly drugs that might not be developed by industry.