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Just the Facts and More: Drug Research
To learn more about Alzheimer's disease and to find effective treatments, researchers need caregivers and patients who are willing to participate in research studies and projects. The message is simple: Research is critical in finding ways to prevent, treat, and cure Alzheimer's disease.
There are many different types of research studies. Some projects focus on psychological aspects, caregiver research, or autopsy findings. The information in this paper focuses on drug research. Additional fact sheets will present highlights about other kinds of research.
Many caregivers believe that participation in research projects and studies offers an opportunity to contribute to the future well-being and health of other patients and caregivers, and to fight back against Alzheimer's disease. You can make the most of your participation in a research study or project by following these guidelines:
The Food and Drug Administration (FDA), in conjunction with the Alzheimer's Association and other professional groups is working to ensure the development of drugs that are effective and safe for the person with Alzheimer's disease. The FDA has appropriately high standards for judging whether the benefits of a medicine likely outweigh its possible risks.
The process involved in drug development, from first identifying the medication in the laboratory to the end stage of introduction into the marketplace, is a slow and expensive procedure. Costs have been estimated between $115 to $150 million to move a drug from the pre-clinical phase to availability to the public. The research funding efforts of the Alzheimer's Association have contributed to the process of developing new drugs.
Phase I: These tests involve about 30 normal, usually healthy volunteers to determine the drug's safety profile in the body. Aspects of the drug's action are also studied (How is the drug absorbed? How does it pass through the body? What is the effect of the drug, and how long does it last? What is a safe dosage range?). This process takes about one year.
Phase II: This phase consists of controlled studies in approximately 100 to 300 volunteer patients (people with the disease) to assess the drug's effectiveness. Simultaneous animal and human studies continue to determine if the medicine is safe. This period of clinical testing takes about two years.
Phase III: Here the testing moves to larger numbers of volunteer patients, usually 1,000 to 3,000 in clinics and hospitals. Physicians give the medicine, and patients are monitored to determine the effect of medication on the disease and to identify adverse reactions. Phase III clinical studies last about three years.
New Drug Application (NDA): Following the successful completion of all three phases of clinical trials, the company sponsor must file an application. The report must contain all the scientific information that the sponsor has gathered. The average review of the application by the FDA (Food and Drug Administration) takes two to three years.
Approval: Once the NDA (new drug application) is approved, the medicine becomes available for your doctor to prescribe. The company must continue to submit periodic reports to the FDA, including any cases of adverse reactions, and appropriate quality control records. For some medicines, the FDA requires additional studies to evaluate long-term effects.
One of the best places to turn for additional help is the Alzheimer's Association. The Alzheimer's Association has more than 83 Chapters and 1,600 support groups nationwide, where family members of people with Alzheimer's disease or a related disorder share their experiences, provide each other with emotional support, hear practical suggestions and learn to rebuild their lives.
The primary resource for this fact sheet was Peter Whitehouse, MD, Ph.D., University Hospitals of Cleveland, Alzheimer Center, Cleveland, Ohio.
Other Resources include:
© 1992 Alzheimer's Disease and Related Disorder Association, Inc. All Rights Reserved.
Posted August 3rd, 2007
There are many different types of research studies. Some projects focus on psychological aspects, caregiver research, or autopsy findings. The information in this paper focuses on drug research. Additional fact sheets will present highlights about other kinds of research.
Many caregivers believe that participation in research projects and studies offers an opportunity to contribute to the future well-being and health of other patients and caregivers, and to fight back against Alzheimer's disease. You can make the most of your participation in a research study or project by following these guidelines:
Understand your motivations.
Review your reasons for participating in the research project. Do you sincerely want to help researchers find a treatment or cure for the disease? Or are you hoping that the patient will improve dramatically by participating in the study? Try not to have unrealistic expectations that the patient will improve greatly or that a cure to the disease will be found while you are participating in the study.Examine the possibilities.
Many clinical drug trials use two groups for testing. One group receives the drug, and the other receives a placebo, or non-medicated "sugar pill." The participants are not told whether the pill is the active drug or the placebo. It is important to understand this procedure.Balance risks and benefits.
In a research study, one cannot be sure before doing the study whether or not the drug will be beneficial. Studies in animals are performed before clinical trials to minimize the risk for human subjects. Some patients may show improvements while others will see little or no improvement. In fact, it's possible that some drugs may cause the person's condition to worsen. Careful monitoring is conducted during a drug study to minimize patient harm.| Action Steps |
Ask questions.
Before making a decision to get involved in a research study, make sure you get satisfactory answers to the following questions:- Purpose of Research
- What is the purpose of this study? Why is it being done? What do the researchers hope to find?
- How will the study be conducted? Who will participate? Where will it be conducted? Over what span of time will the study be conducted? Keep in mind that some studies continue for as long as five years.
- Drugs, Dosage and Effect
- What kind of drug might the patient be given? How large is the dosage and what are the risks involved in taking this dosage?
- How will the drug be given? How will you be involved as a caregiver? What are the other responsibilities that the family might be asked to assume? For example, will you be asked to keep a daily diary? And how often will you be expected to bring the patient to the research site? Who will be your contact person?
- What are the potential side effects of the drug? How might the patient's behavior change as a result of taking the drug? To what extent could the patient's condition become worse?
- Requirements
- What kind of consent form will the patient be asked to sign? Keep in mind that a family member may be asked to sign for the patient. If you have questions or do not understand the form, you might want to talk with the researcher. Don't hesitate to discuss your questions with the patient's personal physician.
- What kind of consent form will the patient be asked to sign? Keep in mind that a family member may be asked to sign for the patient. If you have questions or do not understand the form, you might want to talk with the researcher. Don't hesitate to discuss your questions with the patient's personal physician.
- Costs
- What is the cost of participating in the study - both in time and money? To what extent will travel, lodging, and meal expenses be covered by the research project? How will expenses be reimbursed?
- What is the cost of participating in the study - both in time and money? To what extent will travel, lodging, and meal expenses be covered by the research project? How will expenses be reimbursed?
- Researchers
- What are the credentials of the researchers? Have they conducted similar studies?
- Do you feel that the researchers are people you can work with easily? Do they answer your questions and give the information you request?
- Information and Follow-up
- What kind of reports or information will you receive about the completed research? Will there be follow-up procedures required.
Directions in Research for Alzheimer Treatments
Throughout the United States and worldwide, dozens of medications for those suffering with Alzheimer's disease are being tested in clinical trials. Current drug treatments focus on producing temporary improvements in cognitive impairment. Long term strategies being developed now will attempt to slow the progression of the disease.The Food and Drug Administration (FDA), in conjunction with the Alzheimer's Association and other professional groups is working to ensure the development of drugs that are effective and safe for the person with Alzheimer's disease. The FDA has appropriately high standards for judging whether the benefits of a medicine likely outweigh its possible risks.
The process involved in drug development, from first identifying the medication in the laboratory to the end stage of introduction into the marketplace, is a slow and expensive procedure. Costs have been estimated between $115 to $150 million to move a drug from the pre-clinical phase to availability to the public. The research funding efforts of the Alzheimer's Association have contributed to the process of developing new drugs.
Human Testing (Clinical Trials)
There are three phases of human testing, each involving larger numbers of people than the one before.Phase I: These tests involve about 30 normal, usually healthy volunteers to determine the drug's safety profile in the body. Aspects of the drug's action are also studied (How is the drug absorbed? How does it pass through the body? What is the effect of the drug, and how long does it last? What is a safe dosage range?). This process takes about one year.
Phase II: This phase consists of controlled studies in approximately 100 to 300 volunteer patients (people with the disease) to assess the drug's effectiveness. Simultaneous animal and human studies continue to determine if the medicine is safe. This period of clinical testing takes about two years.
Phase III: Here the testing moves to larger numbers of volunteer patients, usually 1,000 to 3,000 in clinics and hospitals. Physicians give the medicine, and patients are monitored to determine the effect of medication on the disease and to identify adverse reactions. Phase III clinical studies last about three years.
New Drug Application (NDA): Following the successful completion of all three phases of clinical trials, the company sponsor must file an application. The report must contain all the scientific information that the sponsor has gathered. The average review of the application by the FDA (Food and Drug Administration) takes two to three years.
Approval: Once the NDA (new drug application) is approved, the medicine becomes available for your doctor to prescribe. The company must continue to submit periodic reports to the FDA, including any cases of adverse reactions, and appropriate quality control records. For some medicines, the FDA requires additional studies to evaluate long-term effects.
| Resources |
One of the best places to turn for additional help is the Alzheimer's Association. The Alzheimer's Association has more than 83 Chapters and 1,600 support groups nationwide, where family members of people with Alzheimer's disease or a related disorder share their experiences, provide each other with emotional support, hear practical suggestions and learn to rebuild their lives.
The primary resource for this fact sheet was Peter Whitehouse, MD, Ph.D., University Hospitals of Cleveland, Alzheimer Center, Cleveland, Ohio.
Compiled by the Lincoln/Greater Nebraska Chapter of the Alzheimer's Association, 1999.
Other Resources include:
- Alzheimer's Association and Pharmaceutical Manufacturers Association. "Alzheimer's Medicines in Development." Washington, D.C., November, 1989.
- George J. Ana. (1989). "The Rights of Patients: The Basic ACLU Guide to Patient Rights." Carbondale, Illinois: Southern Illinois University Press.
- Nancy L. Mace and Peter V. Rabins, MD. (1991). "The 36-Hour Day." Baltimore: The Johns Hopkins University Press.
© 1992 Alzheimer's Disease and Related Disorder Association, Inc. All Rights Reserved.
