Participating in meaningful medical research
By Robert St. Germain
Have you ever been a guinea pig for science? Would you like to know what it is like? In a word, it’s fascinating! I am talking about leading-edge medical research. I am talking about helping to conquer a dreadful disease — Alzheimer’s. Join me now as I walk you through my participation as a study subject of the Harvard Aging Brain Study (HABS). I want you to feel what it is like to be a participant. Medical science needs you to volunteer. And if you do, you may also feel the deep sense of satisfaction that comes from doing something good for others.
The technical name of the Harvard Aging Brain Study (HABS) is “The Impact of Amyloid on the Aging Brain.” Amyloid is a protein that builds up in the brain as we age. You can think of it as brain sludge. In sufficient quantities, it destroys memory and thinking, a process that is referred to as Alzheimer’s disease. The purpose of HABS is to find out whether changes that are visible on a brain scan are related to early memory changes and thus might provide a tool for diagnosis.
Funded by National Institutes on Aging, the Harvard Aging Brain Study plans to test 300 healthy participants between the ages of 65 and 90 over a five-year period. During this time, we will have four MRI scans, four PET scans, five fasting blood draws, and up to seven sessions of thinking and memory tests. Two spinal taps are requested but are optional. In addition, we must have a study partner who knows us well and is willing to answer about 30 minutes of questions about our daily living experiences and skills. Those interviews will occur several times throughout the five-year period.
Year one is the big year, with seven testing sessions over a six-month period. During that time, we will each provide a complete medical history, including any medications we take or have taken. The HABS staff doctors will give us physical and neurological examinations to establish baselines. Our blood is drawn, and we are asked to fill a little plastic cup with saliva. The researchers are searching for possible indicators of Alzheimer’s in the blood; the DNA from the saliva is used to determine which genes play a role in brain function. We are also asked to wear a pedometer for seven days to track our level of physical activity. That is all pretty standard medical procedure. The fun part is the pencil-and-paper and computer-based tests.
Do you like brain games, especially ones that make you think really hard? The thinking and memory tests the HABS folks have come up with are the brain’s equivalent of 100 push-ups. You sit in a small office with a research associate. He or she reads out a series of numbers or letters or a combination of numbers and letters. You are asked to repeat them back. It’s easy with only numbers or letters up to 6 or 7 digits/characters. But when the count goes up to 8 or 10 or even 12 and they mix numbers and letters and ask you to sort them . . . Wow! That is a challenge.
Other tests involve faces and names. This test was frustrating for me because I have never been good at remembering names. To make this test even more challenging, the HABS researchers next provide us with occupations to remember for each name and face. Try it sometime. It is a real mental workout.
In another test the researcher reads you a long and convoluted story. All you have to do is remember all the details and feed them back. By then, you are getting tired. You are even looking forward to the relative relaxation of rush-hour traffic. But you are not done yet. The next test involves lists of items to remember. Through all these exercises, I wished I had my daughter’s photographic memory.
Finally, you are asked questions about your own life based on the information supplied by your study partner. It’s like the old TV program The Newlywed Game, only instead of knowing your spouse’s favorite color, you are asked to replay the details of various life experiences. My spouse is a detail-oriented person; I am not. What she remembers one hour later is different from what I remember. I probably flunked that test. Give it a try. It could become a new party game.
Visits three and four are for Functional Magnetic Resonance Imaging (fMRI) scans and additional computerized test. Some people find MRIs difficult either because of the tunnel-like structure of the machine or the loud banging noises the machine makes. Neither is a problem for me, and I found the experience to be quite interesting. We are fitted with a special “helmet” that includes a small computer screen. While in the machine we are shown a number of pictures and asked to remember things or make decisions about them. During this time the machine is watching us think. It is what my kids would describe as “very cool.”
Visits five and six are for PET scans. PET scans provide a different kind of view than MRIs. While the machines may look somewhat similar, the MRI offers structural information about brain tissue while the PET scan shows abnormal tissues. For a PET scan, you are injected with a radioactive drug. The radioactivity allows the special PET camera to take pictures of your brain that display amyloid deposits.
Visit seven is for the lumbar puncture, more generally known as a spinal tap. They need your spinal fluid to identify “markers,” certain biological indicators that may predict that you are developing Alzheimer’s. You are asked to lie on your side and curl up into a tight ball position. The doctor will clean a small area on your spine and inject it with Novocain, like what your dentist does to prepare you for a filling. The doctor then inserts a very thin needle into the spinal canal and withdraws about 1½ tablespoons of spinal fluid, which the body replaces in about two hours. For me (and several other participants I have spoken to), it was painless. I was only mildly aware that anything was happening. Afterward, you are asked to abstain from all physical activity for a day.
The remaining visits occur once per year for the remainder of the five-year study. Each features two hours of thinking and memory testing and taking a blood sample. There is also the second round of fMRI and PET scans to look forward to.
Throughout the study you are treated with deep respect and appreciation. You can stop any test in which you feel uncomfortable. You can quit the study if you want. Lastly, you are actually paid a small stipend for each visit to cover expenses and to thank you for your trouble. Test results are not given to you, your family, or your doctor, nor will they ever go into your medical record. They are for research only, but you will be told if a medical problem is found so you can seek care.
Data from studies like this are the gold of medical research. HABS research data are shared with the Broad Institute for whole genome analysis. Much of the data and study information is added to data banks of the NIH for use by others working on various diseases and conditions. Portions of blood, spinal fluid, and saliva samples are stored for future use as new research questions arise in the discovery process.
And the research goes on. In a newly funded prevention study, Doctors Sperling and Rentz, the primary doctors running the HABS, will have 1,000 test subjects spread over 50 sites around the country. The new study builds on what has been learned so far in this study. Each is a step, a very detailed step, along the path to a cure — goal toward which I am gratified to play a part.
If you are interested in participating in the Harvard Aging Brain Study, contact Tamy-Fee Meneide. If you are interested in other studies and trials, please contact Esther Kim.
Rob St. Germain is occupying some of his grand time with freelance writing. A retired management consultant, he lives in Ashland, Massachusetts.