NRC: Project Cores

T T

A D N I

Alzheimer's Disease

Neuroimaging Initiative

Frequently Asked Questions

	:QUESTION:	:ANSWER:
1	DO I GET A COMPLETE PHYSICAL AT THE START?	If the screening evaluation proves that you are eligible for this study, you will come to the clinic for the baseline evaluation. Your blood pressure, pulse and weight will be checked, and a physical examination will be performed, along with documentation of baseline symptoms and a listing of any medications you are currently taking. You will undergo a clinical evaluation and functional, behavioral and memory and thinking skills tests. Blood will be drawn from a vein in your arm and you will be asked for a urine sample.
2	HOW LONG WILL EACH VISIT TAKE?	Approximately 4 hours.
3	WHERE WILL THE STUDY OCCUR?	The study will take place at approximately 59 academic medical centers across the United States and Canada.
4	HOW MANY VISITS ARE NECESSARY?	4 visits if you have been diagnosed with Alzheimer’s disease; 5 visits if you have no problems, and 6 visits if you have mild memory problems.
5	WILL I BE COMPENSATED FOR MY TIME AND TROUBLE? – HOW MUCH?	ADEAR RESPONSE: “The costs you incur for time and expenses due to your participation in this study will be compensated. The study site where you would enroll, determines the method and exact amount of compensation”. SITE RESPONSE: Please determine your site’s policy so that you can provide a clear answer to the caller.
6	HOW MANY PATIENTS WILL BE IN THIS STUDY?	At total of 800. Approximately 200 cognitively normal older individuals will be followed for 3 years, 400 people with MCI will be followed for 3 years, and 200 people with early AD to be followed for 2 years.
7	IS THIS THE FIRST STUDY OF ITS KIND?	Yes.
8	HOW MANY MRIs WILL BE DONE?	The number of MRIs will be determined at the screening visit and will be between 4 and 10, depending on your study group and the length of your study participation.
9	HOW MANY PET SCANS WILL BE DONE?	Some participants will be studied without PET scans and for all others the number of PET scans will be determined at the screening visit and will be between 4 and 6, depending on your study group and the length of your study participation.

10

CAN I BE INVOLVED IN OTHER CLINICAL TRIALS?

No, participation in another clinical trial would require you to withdraw from this study.

11

I AM AFRAID OF CLOSED IN SPACES, WILL I BE OK IN THIS STUDY?

There are no open MRIs. If you have a severe problem with claustrophobia, it is recommended that you not participate in this study.

12

WHAT ARE THE RISKS OR SIDE EFFECTS OF MRIs?

There are no risks from the actual procedure, but some people experience anxiety due to claustrophobia and noise. If you experience anxiety when placed into the MRI scanner you will be removed from the scanner, offered reassurance by the MRI technician doing the scan, and offered the option of continuing or terminating the study.

People with pacemakers, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in their eyes are not permitted to have an MRI.

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If there is non-surgical metal in the body, such as shrapnel, this can cause internal pain or bleeding. There is a slight risk that someone will bring metal into the MRI room, which can cause bodily harm, but the room is closed during the exam and there are metal detectors and other protection devises to prevent this.

13

WHAT ARE THE RISKS OR SIDE EFFECTS OF PET SCANS?

Some participants will be studied without PET scans.

The risks associated with a PET scan are minimal. They are considered safe and there has not been a report of an adverse event with this type of use. The risk from radiation exposure of the amount used is considered to be similar to other every day risks, such as driving a car.

14

IS A LUMBAR PUNCTURE REQUIRED?

No. Some participants will be studied without lumbar punctures.

15

WHAT ARE THE RISKS OR SIDE EFFECTS OF A LUMBAR PUNCTURE (SPINAL TAP or DRAWING CEREBROSPINAL FLUID)?

Some participants will be studied without lumbar punctures.

Headache may occur in about 5% of people who undergo lumbar puncture. The following risks are rare (less than 1 %). They include infection, damage to nerves in the back and bleeding into the cerebral spinal fluid space. They are even less likely for people with Alzheimer’s disease.

16

HOW MANY LUMBAR PUNCTURES (SPINAL TAPS) WILL BE DONE?

Some participants will be studied without lumbar punctures. Two – the first at the beginning; the second 12 months later.

17

HOW MANY TIMES WILL BLOOD BE DRAWN AND HOW MUCH?

4 times if you have been diagnosed with Alzheimer’s disease; 5 times if you have no problems and 6 if you have mild memory problems. Approximately 57 milliliters (about 12 teaspoons) of blood will be drawn each time.

18	HOW MUCH SPINAL FLUID IS TAKEN EACH TIME?	Some participants will be studied without lumbar punctures. About 22 milliliters (1½ tablespoons) of spinal fluid will be removed for analysis and storage. Your body replaces this spinal fluid within 1-2 hours.
19	WHAT WILL HAPPEN IF I GET SICK AS A RESULT OF THE STUDY?	Although it is very unlikely that you will become ill as a result of these study procedure, you must report ANY suspected illness or injury to the study doctor immediately. If such problems take place, your research site will provide emergency medical treatment and will assist you in getting proper follow-up medical treatment. The sponsor, coordinating center or NIA will not provide compensation for research-related injury”. The individual research site of your participation will handle such a case and will discuss with you in detail their responsibilities.
20	IF I DEVELOP ALZHEIMER’S, WILL I GET MEDICATION?	Should you develop Alzheimer’s, medication can be recommended and discussed with your primary care physician but the cost for medication will have to be covered by you or your insurance.
21	I AM ON MEDICATION – DOES IT MAKE A DIFFERENCE?	This will be determined during your screening visit. Most medications are permitted if you have been stable on them for at least 4 weeks prior to the screening visit.
22	WHAT WOULD HAPPEN IF CAN’T MAKE APPOINTMENT ?	Be sure to contact the research site and let them know so that you can reschedule your visit.
23	HAS THIS KIND OF STUDY BEEN DONE BY NIH BEFORE?	No.
24	WHAT HAPPENS WITH THE INFORMATION THAT WAS COLLECTED DURING THE STUDY?	All clinical, imaging and biological data collected will be made available promptly to all qualified scientific investigators in the public and private sector. After 5 years, analysis of the collected information will still be ongoing. All collected data will be anonymous and major efforts will be made to keep your identity completely secret.
25	IF THEY DISCOVER SOME OTHER ILLNESS, WOULD I BE INFORMED?	Yes.
26	WOULD MY INSURANCE OR DMV FIND OUT ABOUT MY BEING IN THIS STUDY?	No.

27	WILL THE OUTCOME BE PRODUCING A DRUG?	The results of the study will help improve the clinical evaluation of new drugs, on a continuing basis. The pharmaceutical companies are providing $20 million support this project, which is strong evidence of the importance of this project for drug development.
28	WILL I HAVE ACCESS TO THE INFORMATION THAT WAS COLLECTED?	You will not have access to the collected information; however, you will be informed if any illness is discovered during the course of the study.
29	WILL I BE TOLD THE RESULTS OF ANY OF MY TESTS?	Your physician will be informed if any significant clinically relevant abnormalities are detected.
30	DOES A FRIEND OR RELATIVE HAVE TO ACCOMPANY ME AT EVERY VISIT?	No, for some visits a friend or relative may be contacted by telephone, if they cannot accompany you.
31	WHAT ABOUT CONFIDENTIALITY?	All collected data will be anonymous and major efforts will be made to keep your identity completely secret.

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Patient Privacy Statement

10	CAN I BE INVOLVED IN OTHER CLINICAL TRIALS?	No, participation in another clinical trial would require you to withdraw from this study.
11	I AM AFRAID OF CLOSED IN SPACES, WILL I BE OK IN THIS STUDY?	There are no open MRIs. If you have a severe problem with claustrophobia, it is recommended that you not participate in this study.
12	WHAT ARE THE RISKS OR SIDE EFFECTS OF MRIs?	There are no risks from the actual procedure, but some people experience anxiety due to claustrophobia and noise. If you experience anxiety when placed into the MRI scanner you will be removed from the scanner, offered reassurance by the MRI technician doing the scan, and offered the option of continuing or terminating the study. People with pacemakers, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in their eyes are not permitted to have an MRI. ----------------------------------------------------------------- If there is non-surgical metal in the body, such as shrapnel, this can cause internal pain or bleeding. There is a slight risk that someone will bring metal into the MRI room, which can cause bodily harm, but the room is closed during the exam and there are metal detectors and other protection devises to prevent this.
13	WHAT ARE THE RISKS OR SIDE EFFECTS OF PET SCANS?	Some participants will be studied without PET scans. The risks associated with a PET scan are minimal. They are considered safe and there has not been a report of an adverse event with this type of use. The risk from radiation exposure of the amount used is considered to be similar to other every day risks, such as driving a car.
14	IS A LUMBAR PUNCTURE REQUIRED?	No. Some participants will be studied without lumbar punctures.
15	WHAT ARE THE RISKS OR SIDE EFFECTS OF A LUMBAR PUNCTURE (SPINAL TAP or DRAWING CEREBROSPINAL FLUID)?	Some participants will be studied without lumbar punctures. Headache may occur in about 5% of people who undergo lumbar puncture. The following risks are rare (less than 1 %). They include infection, damage to nerves in the back and bleeding into the cerebral spinal fluid space. They are even less likely for people with Alzheimer’s disease.
16	HOW MANY LUMBAR PUNCTURES (SPINAL TAPS) WILL BE DONE?	Some participants will be studied without lumbar punctures. Two – the first at the beginning; the second 12 months later.
17	HOW MANY TIMES WILL BLOOD BE DRAWN AND HOW MUCH?	4 times if you have been diagnosed with Alzheimer’s disease; 5 times if you have no problems and 6 if you have mild memory problems. Approximately 57 milliliters (about 12 teaspoons) of blood will be drawn each time.