Jan 14, 2011

How to Find and Get Into an Alzheimer's Clinical Trial

If you are interested in identifying a clinical trial for a new experimental Alzheimer's disease drug or treatment, I encourage you to do so.

If you are interested in identifying a clinical trial for a new experimental Alzheimer's disease drug or treatment, I encourage you to do so.

By Bob DeMarco
Alzheimer's Reading Room

You might benefit from the experimental medication; and, you will be helping to advance the search for a cure or treatment.

You can also benefit from all the medical tests that are included in most clinical trials.

All open and approved clinical trials are registered at Clinical Trials.gov.

You never pay anything out of pocket for a clinical trial that is approved by the FDA. Clinical trials are free to the participants. The clinical trial sponsor (usually a pharmaceutical company) is responsible for the payment of all costs.

All open clinical trials are actively seeking and recruiting new participants. One of the biggest problems right now is finding enough participants for those clinical trials that are now ongoing.

As a result, you will find that participating clinics are waiting for your call, and anxious to determine if you meet the suitability requirements to enter a clinical trial.

To find a clinical trial, go to Clinical Trials.gov. If you know how to search for information on the Internet, you will find the process of getting a list of clinical trials very easy.

Searching is as simple as entering a disease or illness into a search box in the upper rigtht hand corner of the website. For example, you can enter the word "alzheimer's" into the search box to get a list of every Alzheimer's disease clinical trial and its current status (recruiting new participants, not yet recruiting new participants, completed).

You can also enter the illness and your location. For example: Alzheimer's Delray Beach. This would give me a list of the clinical trials that are available near us. I would suggest you use broader criteria when searching like "Alzheimer's Florida". You can always narrow your search.

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Each clinical trial page is loaded with information. This includes but is not limited to:
  • Purpose and condition
  • Primary and Secondary Outcome Measure
  • Enrollment
  • Study size
  • Eligibility
  • Inclusion and Exclusion Criteria
  • Contacts and Location
You should pay close attention to the three I highlighted above.
  • For eligibility: age and gender are important. For example, my mother is too old for the majority of Alzheimer's clinical trials now available.
  • The list of inclusion and exclusion criteria vary, but they are spelled out clearly on the clinical trial page. Exclusion criteria vary widely but you could be ruled out if you are taking a conflicting drug, or have an alcohol or drug addiction. You will be ruled out of most clinical trials if a stable, reliable, committed caregiver is not in place.
  • Location is a major factor in identifying and selecting a clinical trial. If it is not national study with a location near where you live, it won't make sense to apply.
If you are near a suitable location, the contact process is simple. You call, they ask a series of questions, and if there are no obvious exclusions they will set you up with an appointment to come into the office. Most clinical trials also offer email contact. My advice is to call.

When you arrive for your appointment, you will be asked a battery of questions. At this point, you might receive one or more documents that describe the clinical trial. These documents are rather long and somewhat technical. They also disclose all the risks associated with the clinical trial.

If you receive the clinical trial disclosure documents, it would be a good idea to discuss these with your personal care physician. You might also check with friends or an association to get some help with the technical jargon and discussion of the risks associated with the trial.

If you make it this far, you will then be subjected to a series of tests that will likely include the Mini-Mental State Examination and other memory tests. A complete physical and blood work-up are also part of the process. You might need to acquire copies of previous tests like MRIs.

A this point you find out if you are accepted or rejected. Any rejection criteria will be explained to you.

If you are accepted into a clinical trial, you won't be expected to pay any of the costs. The pre-qualification testing is also free. If you are asked for any money while applying for a clinical trial -- walk out the door.

All the costs are absorbed by the clinical trial sponsor. It is possible that you will be reimbursed for things like travel.

If you are interested in identifying a clinical trial, I encourage you to do so. You might benefit from the experimental medication; and, you will be helping to advance the search for a cure or treatment.


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Clinical research is medical research involving people. There are two types, clinical studies and clinical trials.

Clinical studies (sometimes called observational studies) observe people in normal settings. Researchers gather information, group volunteers according to broad characteristics, and compare changes over time. For example, researchers may collect data through medical exams, tests, or questionnaires about a group of older adults over time to learn more about the effects of different lifestyles on cognitive health. Clinical studies may help identify new possibilities for clinical trials.

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups.

Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.

Source National Institute on Aging

Original content Bob DeMarco, Alzheimer's Reading Room