Boomer health: Drug offers hope for Alzheimer's prevention

March 24--With every passing year, increasing numbers of baby boomers move into the demographic -- 65 and older -- that puts them in the cross hairs of Alzheimer's disease.

And, not surprisingly, our senior-citizen-heavy state has one of the highest concentrations of Alzheimer's patients in the nation.

"Florida is home to nearly 10 percent of the estimated 5.2 million individuals in the U.S. who suffer from Alzheimer's disease," says Cleveland Clinic Florida neurologist Dr. Nestor Galvez.

With Alzheimer's being the sixth-leading cause of death in the U.S. (approximately 500,000 annually), the fear in the health care community is that that number will skyrocket in the coming decades.

Some Alzheimer's advocacy organizations project that, by 2030 (when all boomers are 65 and older), more than 7 million Americans will be diagnosed with the disease. The extrapolated figure more than doubles to 16 million by 2050.

That's why Galvez and his colleagues at Cleveland Clinic Florida are partaking in a new, long-term, nationwide clinical trial designed to test the efficacy of using an FDA-approved diabetes drug to prevent Alzheimer's.

And they need your help.

"TOMORROW" trial

Researchers at Cleveland Clinic and other participating facilities are testing two factors in potentially preventing Alzheimer's: 1) whether a new genetic biomarker, TOMM40, is an additional indicator of a patient's elevated risk of developing the disease; and 2) whether pre-emptive use of the Type 2 diabetes medication, pioglitazone, inhibits the development of Alzheimer's in otherwise healthy subjects.

The thinking is that the anti-inflammatory properties of pioglitazone can protect the brains of those who may be at higher risk for developing Alzheimer's from actually getting the disease.

And who's at "higher risk" for developing Alzheimer's?

Well, in addition to those with a family history of the disease, researchers believe that the genetic biomarker TOMM40 is also associated with an increased predisposition for Alzheimer's.

Thus, the 120 candidates that Cleveland Clinic Florida ultimately selects -- who must be between the ages of 65 and 83 and exhibiting no signs of cognitive impairment -- will undergo genetic blood testing for both TOMM40 and APOE (a biomarker that previous studies have shown suggests an increased Alzheimer's predisposition).

"What makes this study unique is that most of the clinical trials for Alzheimer's focus on treatment of people who already have memory issues," explains neurologist Dr. Po-Heng Tsai. "This trial focuses on people who are currently normal, and will study whether a drug could delay the onset of memory loss."

The only currently FDA-approved Alzheimer's medications -- called "cholinesterase inhibitors" -- do nothing to delay the progression of the disease. Rather, they (might) temper some of the early-stage symptoms of the disease.

Those deemed suitable to participate in the controlled, double-blind study -- which is scheduled to last five years -- will ingest a single daily dose of the oral medication. According to Tsai, the drug is "well-tolerated with very few side effects." Researchers will then track test subjects with follow-up phone conversations every three months, and yearly in-person checkups.

"The participants in the TOMORROW study -- individuals who have not yet been affected but have a real possibility of a future with Alzheimer's -- have an invaluable role to play in helping researchers achieve breakthroughs," says Tsai.

For those interested in participating in Cleveland Clinic Florida's TOMORROW study, call 844-ALZ-TRIAL or 954-659-6428.

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