What is Alzheimer's disease?
Alzheimer's Disease (AD) is the fourth leading contributing cause of death among the elderly. Of the many forms of dementia, AD is the most common affecting roughly 10% of our population over 65 years old, and as much as 50% of those 85 and older. It is characterized by confusion, depression, paranoia and gradual loss of memory.

What are the symptoms of Alzheimer's disease?
Alzheimer's disease can affect different people in different ways, but the most common symptom pattern begins with gradually worsening difficulty remembering new information. As the disease progresses, individuals also experience confusion, disorganized thinking, impaired judgment, difficulty remembering recent events, trouble expressing themselves, and disorientation.

My older sister has Alzheimer's. Will I get it too?
Possibly, though not necessarily. Those with siblings who develop AD are at greater risk than those without, but it isn't a sure thing.

A neighbor's husband was diagnosed with Alzheimer's last year at age 52. He died last month. I thought Alzheimer's lasted for years and years? Are there two types?
Yes. Familial Alzheimer's (or Early Onset Alzheimer's) is a much more aggressive illness than the usual 'senile onset' variety. As the name implies, it is hereditary and can strike anytime between ages 30 and 55. The youngest case we have encountered thus far was age 42 at diagnosis and died less than nine months later. Familial cases make up less than 10% of all AD victims.

My mother was recently diagnosed with early stage Alzheimer's and the doctor advised me to start looking into institutional care. I would prefer to keep her at home and care for her myself for so long as she has left; isn't this an option?
For the short term, probably. Caregiving is easiest in the early stages and grows increasingly more difficult and tedious as the disease progresses. Eventually a point is reached where home care may not be practical, even with hired nursing help. A responsible caregiver should learn to recognize this point and accept the fact that advanced AD patients need more care than she is capable of providing. The physical and emotional strain on the caregiver should also be a factor in this decision.

I have read that aluminum may be involved in Alzheimer's. Should I avoid using products containing aluminum?
The brain tissue of AD patients exhibit higher than usual concentrations of aluminum, bromide and silicon. Its role as a causative agent, however, has not been shown in clinical studies. Canada, where water systems are routinely made of aluminum, does not have a higher incidence of AD than, say, Zambia where aluminum is rarely used in any capacity.

The rise of aluminum use after World War II and the increased frequency of AD in the same period may well be coincidental. Consider that during the same time span, new antibiotics and improved treatments for cancer, heart disease, etc also came about which enabled us to live longer. This may be the actual cause rather than aluminum.

Why hasn't a cure been found yet?
Unlike an illness caused by bacteria, Alzheimer's has a range of causative factors. Add to this the fact that AD rarely exists in a vacuum; the patient usually has other conditions that must be treated also. This opens the door for drug-drug interactions that can be problematic if not fatal. Now consider the difficulty in getting any substance across the blood-brain barrier and you'll see the challenge facing researchers. At present it appears that a 'preventative' rather than a cure per se is more likely. Several studies are in progress to find a means of interrupting the formation of plagues (and resultant destruction of neurons) by disrupting the protein formations involved in the process.

What is a clinical trial?
A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.

Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria.” These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

What are the benefits and risks of participating in a clinical trial?
Benefits
Clinical trials that are well-designed and well-executed are the best treatment approach for eligible participants to: Play an active role in their own health care. Gain access to new research treatments before they are widely available. Obtain expert medical care at leading health care facilities during the trial. Help others by contributing to medical research.

Risks
There are risks to clinical trials. There may be unpleasant, serious or even life-threatening side effects to treatment. The treatment may not be effective for the participant. The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.

Who sponsors clinical trials?
Clinical trials are sponsored or funded by as variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

What are the different types of clinical trials?
Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Screening trials test the best way to detect certain diseases or health conditions. Quality of life trials (or supportive care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness of condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

Does a participant continue to work with a primary health care provider while in a trial?
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol; a study plan that details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

The above information is from the ClinicalTrials.gov web site, a service of the National Institutes of Health, developed by the National Library of Medicine.