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ICARA Study

A clinical study to compare the effect of bapineuzumab with the effect of placebo for the treatment of Alzheimer's disease.

ICARA Study

We are asking you to consider taking part in a clinical research study of an investigational drug for the treatment of Alzheimer's disease.

Before you agree to participate, it's important to make sure that you understand Alzheimer's disease, clinical research studies, and specifically, the purpose of the ICARA study.

After reviewing this information, it is important to thoroughly read the informed consent document. This document further describes your rights as a participant, and includes additional details about the study.

Overview

1. What is Alzheimer's disease?
2. What is a clinical research study?
3. The ICARA study
4. What is the purpose of the ICARA study?
5. What is your commitment to the study?
6. Study-related benefits
7. What are the possible risks?
8. Remember . . .

1. What is Alzheimer's disease?

• Alzheimer's disease is a neurodegenerative disorder— a disorder in which brain and spinal cord cells are lost. It is characterized by progressive loss of memory and cognitive function, such as movement control and decision-making ability.
• There are three stages of Alzheimer's disease: mild, moderate, and severe.
  1. Mild—In the early stage of the disease, patients have a tendency to become less energetic or spontaneous, though changes in their behavior often go unnoticed even by the patients’ immediate family.
  2. Moderate—As the disease progresses, patients might still be able to perform tasks independently (such as using the bathroom), but may need assistance with more complicated activities (such as paying bills).
  3. Severe—At this stage, patients will not be able to perform even simple tasks independently and will require constant supervision. They become incontinent of bladder and then incontinent of bowel. They will eventually lose the ability to walk and eat without assistance. Language becomes severely disorganized, and then is lost altogether. They may eventually lose the ability to swallow food and fluid.
• Alzheimer's disease is the most common cause of dementia in the elderly and affects about 18 million people worldwide—5 million in the U.S. alone.
• The current medications are mostly aimed at maximizing the remaining brain activity.

Therefore, a new investigational treatment option is greatly needed to help slow disease progression.

2. What is a clinical research study?

• A clinical research study involves people who volunteer to receive an investigational treatment under close medical supervision.
• All clinical studies are reviewed by the U.S. Food and Drug Administration and an Institutional Review Board, whose job is to make sure participants’ rights are fully protected and that participants are not exposed to any unnecessary risks.
• All drugs must go through three phases of clinical research before becoming available to the public:
  1. Phase I – This phase focuses primarily on safety in a small number of human volunteers
  2. Phase II – This phase tests the effectiveness of the new drug on a small number of human volunteers
  3. Phase III – This phase usually tests the new drug in comparison with the standard therapy currently being used on a larger number of human volunteers

Note – Every volunteer is important – without volunteers there would be no new investigational drugs.

3. The ICARA study

• The ICARA study is a Phase III clinical research study for patients with a diagnosis of probable Alzheimer's disease.

• The research study is sponsored by Elan Pharmaceuticals, Inc. and Wyeth Pharmaceuticals.

4. The purpose of the ICARA study

• The current treatments for Alzheimer's disease are mostly aimed at maximizing the remaining brain activity.

• The ICARA study is looking at whether an infused investigational drug (bapineuzumab) is safe and effective at slowing down disease progression.

5. What is your commitment to the study?

• Your involvement in the study includes 15 visits:
  1. Screening visits (visits 1 and 2)
  2. Treatment visits (visits 3, 5, 7, 9, 11, 13)
  3. Interim visits (visits, 4, 6, 8, 10, 12, 14)
  4. Termination visit (visit 15)
• Screening visits:
  1. Complete medical history will be taken
  2. Physical and neurological exams
  3. Measurement of vital signs
  4. Blood draw and urine sample
  5. Medical questionnaires to asses neurological status
  6. Magnetic resonance imaging (MRI) of the brain
  7. Cognitive, functional, and health outcome assessments
• Treatment visits:
  1. You will receive an infusion of the study drug at all treatment visits
  2. For the first two treatment visits, you will remain at the clinic for observation for at least 4 hours
  3. For the remaining treatment visits, you will remain at the clinic for observation for at least 2 hours
• Interim visits:
  1. Physical and neurological exams
  2. Electrocardiogram (ECG)
  3. Measurement of vital signs
  4. Blood draw
  5. Neurological assessments
  6. Assessment of general well-being
  7. MRI of the brain
• Termination visit:
  1. Neurological assessments
  2. ECG
  3. Physical and neurological exams
  4. Measurement of vital signs
  5. Blood draw
  6. Assessment of well-being

Be prepared to explain procedures, such as MRI, vital signs, physical and neurological exams, neurological assessments, etc.

Sub Studies: If your site is participating in any of the additional sub-studies (e.g., PK/PD/ECG, volumetric MRI, PET, or CSF), please be prepared to explain them to the patient should the patient be willing to participate.

6. Study-related benefits

• All participants in the ICARA study will receive close medical supervision and ongoing general health assessments of their medical condition.
• The study drug may help to control your disease progression or it may not help to control your disease progression.
• No direct benefit is promised or guaranteed. Your participation may benefit others in the future, including others with Alzheimer’s disease, from what is learned in this trial.

7. What are the possible risks?

• All government-approved medications or procedures are associated with potential risks and side effects; the same is true with investigational medications.
• The study doctor will thoroughly discuss with you the possible risks and side effects.
• We encourage you to ask questions and fully understand any risks or side effects.

8. Remember. . .

• Read the informed consent document and go over it with one of the study doctors or nurses.
• Participation in this study is voluntary.
• You can withdraw from the study at any time.

Please click this link ICARA Apolipoprotein ε Allele fact sheet for patients.

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