ASOCIACION DE ALZHEIMER DE PUERTO RICO
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Edif. Santurce Medical Mall E-Mail: alzheimerpr@alzheimerpr.org |
Alzheimer's Disease |
INVESTIGATION INTO MEDICATIONS
In order to learn more about Alzheimer's disease and to find effective treatments, investigators need the cooperation of the caregivers and patients who wish to participate in studies and investigative projects. Investigation is essential to find ways that help prevent, treat and cure Alzheimer's disease.
There are different types of investigative studies. Some of these investigations are focused on psychological aspects, others on the investigation of the caregiver, and still others on the results of an autopsy. Additional bulletins are presented, summarizing the most important points about other types of related investigations with regard to medications.
Many caregivers believe that participation in projects and investigative studies offer the opportunity to contribute to the future health and well being of other patients and caregivers in the fight against Alzheimer's disease. You may contribute with your participation in the studies and investigative projects by observing the following points:
Understand Your Motives.
Analyze the reasons you would want to participate in an investigative project. If you really want to help the investigators find a treatment or cure for the disease, or wait until the patient improves, don't try to have unrealistic hopes that the patient will improve greatly, or that a cure is found for the illness while you are participating in the study.
Examine the Possibilities.
Many clinical evaluations of medications use two groups for the test. One group receives the medication and the other receives a substitute, "Sugar Pill", lacking any medicinal properties. The participants are not told if it is an actual medication or substitute. It is important that this procedure is understood.
Risks and Benefits.
In an investigative project, one cannot be sure before doing the study if the medication will be beneficial. The studies in animals are done before the clinical studies, in order to lower the risks in humans. Some patients may show some improvement, while others little or none. In fact, it is possible that on some occasions the medication may be what has made the patient worse. A careful control must be taken in order to cause less damage to the patients.
STEPS TO FOLLOW
Obtain Information.
Before making a decision to participate in an investigative study, be sure to obtain all the satisfactory answers to the following questions:
Purpose of the Investigation.
What is the purpose of the study?
What are they doing the study for?
What do the scientists hope to find?
How will the study be conducted?
Who will participate?
Where will the investigative study take place?
How long will the study take?
Remember that some investigative studies take months and sometimes even years.
Drugs, Dosages and Effects.
What type of medication will the patient be given?
What is the dosage and what risks are there by taking them?
How will the medication be administered? (Frequency, schedule and route)
How will the caregiver participate?
What are the other responsibilities of the other members of the family?
For example, Will a daily log be requested?
With what frequency will the patient have to go to the place of investigation?
Who will be the contact person?
What are the side affects of the medications?
How will the behavior of the patient change as a result of taking the medications?
To what degree can the conditions improve or worsen for the patient?
Requirements.
Is there any type of document or consent form that will be required for the patient to sign?
Remember that a family member can sign for the patient. If there are any questions and you do not understand the form, you may discuss this with the investigator. Do not be afraid to discuss your questions with the patient's doctor.
Costs.
What is the cost for participating in the study?
Will the transportation, housing and meal costs be covered by the investigative project?
How will these costs be reimbursed?
Investigators.
What are the credentials of the investigators?
Have they conducted similar studies?
Do you feel that the investigators are people that you can work with easily?
Do they answer your questions and give you the information you ask of them?
Information and Procedures.
What type of reports or information will you receive with regard to the investigation once completed?
Will there be procedures after the investigation that will be required?
The Investigation for Treatments for Alzheimer's Disease.
Throughout the United States and around the world, dozens of medications are being evaluated in clinical tests, for those who suffer from Alzheimer's Disease.
The treatments of the actual medications focus on producing temporary improvements to the cognitive damage. The long term strategies that are being developed now, contribute to lowering the development of the disease.
The (FDA) Food and Drug Administration, together with the Alzheimer's Association and other professional groups are working to assure that the development of medications are effective and safe for people with Alzheimer's Disease. The FDA has strict and appropriate regulations to evaluate if the benefits of the medications outweigh the risks.
The procedure involved required in the development of the medication, is identifying the medication in the laboratory until the final stage, including the expenses that are estimated between 115 and 150 million dollars, to move a medication from the pre-clinical phase to the public's reach. The Foundation for the Investigation of the Society of Alzheimer's has contributed to the process of development of new medications.
Tests in Humans (Clinical Tests)
There are three phases in the evaluation of humans and each one involves more people than the previous one.
Phase I
These tests require approximately 30 healthy normal volunteers to determine the safety level of the medication in the body. The reaction of the medications are also studied (how it is absorbed, how it passes through the body, the affect it has on itself, the time it takes and the safe timing of dosage). This process takes about one year.
Phase II
Consists of controlled studies of about 100 to 300 voluntary patients (persons with the illness) to evaluate the effectiveness of the medication.
The simultaneous studies in animals and humans are to determine if they are safe. This period of Clinical Testing takes approximately two years.
Phase III
Here the test involves a greater number of voluntary patients, usually 1,000 to 3,000 in Clinics and Hospitals.
The medication is administered by a physician and the patients are controlled so it can be determined the effect of the medication on the illness and to identify adverse reactions. The Clinical Studies of phase III take approximately three years.
Application of the New Drug (NDA)
Following the successful results of the three phases of Clinical Tests, the Sponsoring Company must fill out an application. The report must contain all the scientific information that the sponsor has saved. The result of the revision of the application by the FDA takes approximately two or three years.
Approval.
Once the application for the new drug is approved, the medicine is available for a doctor to prescribe. The company must continue turning in periodical reports to the FDA, including any cases of adverse reactions and the appropriate results of quality control.
In some medications the FDA requires additional studies to evaluate the long-term effects of the drug.
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