Donate Your Brain to Science –Now

By Sylvia Whitman  |  Illustration by Darcy Kelly Laviolette

According to a global Harris poll, 62% of adults around the world worry that they may develop Alzheimer’s Disease (AD). This fear is not unfounded. The National Institute on Aging reports that more than 5.5 million Americans may have AD, “an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually the ability to carry out the simplest tasks.” Recent estimates have ranked AD as the third leading cause of death in older people, behind heart disease and cancer. As caretakers have so poignantly observed, AD robs people of their past as well as their future.

There is no cure for Alzheimer’s Disease. Yet. 

That’s where you might come in.

Sarasota’s Roskamp Institute, a world-class research institute focusing on neuropsychiatric and neurodegenerative disorders and addictions, is recruiting volunteers for clinical trials of a treatment to prevent or delay the onset of AD in people at greater genetic risk of developing the disease. Sarasota is more than 100 sites in the United States collaborating with global healthcare company Novartis, biotech firm Amgen, and Banner Alzheimer’s Institute on this study.  If you qualify, you will receive an experimental drug or a placebo, genetic counseling, and close monitoring over the 5-8 years of the trial—at no cost. As principal investigator Dr. Andrew Keegan emphasizes, the trial follows strict FDA protocols for informed consent, so clinicians will explain risks and benefits, and you may exit at any time.

That Harris poll mentioned earlier found that an overwhelming number of respondents believe that the solution to health problems lies in medical research, and 79% are willing to participate. Trouble is, most of them said they have no clue how to get involved.

So, here’s the 411 on Roskamp’s Alzheimer’s prevention initiative, Generation Program.

Do You Have What It Takes to Be a Guinea Pig?

For this study, researchers are looking for men and women between the ages of 60-75 who have not been diagnosed with any memory impairment. Participants also need a study partner (anyone, not just a spouse or child) who sees them regularly and is willing to accompany them on required visits several times a year.

To enter the trial, volunteers must have one or both of these AD risk factors: 1) one or two copies of the APOE e4 gene and 2) elevated amyloid plaques. Everyone has a pair of APOE genes, one inherited from dad and one from mom. Only the e4 variation has been implicated in AD dementia. Similarly, everyone’s brain produces amyloid plaques, but a higher-than-normal level of these proteins has been linked to dementia. Just because you have one or both of these conditions does NOT mean that you will automatically develop Alzheimer’s disease. 

Most folks don’t know if they have these risk factors, so Roskamp screens candidates.

Step 1: Learn more about Generation Program through the website (generationprogram.com/#Main) or by phone (1.866.244.8907).

Step 2: If you don’t know your APOE gene variation, you need to give a DNA sample through a cheek swab. You can request the kit and submit this through the mail or do the swab at the Roskamp Institute.

Investigators will call back only a subset of people after the cheek swab. Some will have one or two APOE e4 genes; others will have other variations. Why call back those with both negative and positive results? Investigators want to offer genetic counseling rather than delivering that message indirectly.

Step 3: If you’re eligible and want to enroll, investigators will educate you about what lies ahead. They determine amyloid plaque levels through either a PET scan, which pictures the brain with a radioactive dye.

Step 4: After a full physical exam, tests, and blood workup, participants receive either the new drug being tested or a placebo pill. After the “intense” first three months, the time demands fall sharply. Participants return several times a year for follow-up visits.

Risks and Benefits of Volunteering

Age is the greatest risk factor for Alzheimer’s disease, but finding out that you carry a higher-risk gene or amyloid protein concentration can rattle your equanimity. Receiving screening through this study—rather than through a mail-order DNA kit, for instance—guarantees you genetic counseling, of use to you and perhaps other blood relatives. Should the (free) medical monitoring reveal unrecognized cognitive impairment or other health problems, the Roskamp team will make referrals, allowing early intervention.

Volunteers may receive compensation for time and travel. But the modest financial perks pale beside the greater good of the study. Yes, experimental drugs sometimes have unexpected side effects on the heart and liver, says Dr. Keegan. All the sites in this study pool their ongoing data, “regularly reviewing the safety parameters.” Sometimes a negative outcome can shut down a study. But so too can an overwhelmingly positive trend. Investigators may end a trial early because the drug is so outperforming the placebo that they want to offer it to a wider pool of patients. 

If you are at higher risk of AD, you may be receiving the cutting-edge treatment that holds it at bay. “You could be the one that gets helped,” confirms Dr. Keegan, a practicing neurologist as well as researcher. “But the best people we recruit aren’t looking to help themselves. They’re really doing it to help the next guy. If it benefits them, well, that’s a total win. But they’re really doing it to help others out.”

Even if you don’t qualify for this study, you can still join the fight against Alzheimer’s or other neurological diseases. Roskamp Institute runs other studies. And you can spread the word about how to take care of yourself into old age. “It’s the same old story,” says Dr. Keegan. “Don’t smoke. Treat sleep apnea. Eat right. Exercise is my big thing. And socialize—make sure you’re with people, sharing stories.”

This could be one of them.