LOS ANGELES, CA (Catholic Online) - The trials are historically unprecedented. According to Dr. Francis S. Collins, director of the National Institutes of Health, the trials are "the first to focus on people who are cognitively normal but at very high risk for Alzheimer's disease."

Most of the study's participants will be drawn from an extended family of 5,000 people who live in Medellín, Colombia, and remote mountain villages outside that city, a family that is believed to have more members afflicted with Alzheimer's than any other place in the world.

Those who possess the specific genetic mutation begin showing cognitive impairment around age 45, and full-blown dementia around age 51. The 300 family members who participate in the initial phase of the trial will be years away from developing symptoms, many as young as 30.

The $100 million study will run for five years. The results on sophisticated tests may indicate in as little as two years whether the drug is helping to delay memory decline or brain changes.

Dr. Eric M. Reiman, executive director of the Banner Alzheimer's Institute in Phoenix, and a lead researcher on the study, says that though a relatively small percentage of people with Alzheimer's have the genetic early-onset form that affects the Colombian family, the trial is expected to answer questions that could apply to the millions of people worldwide who will develop more conventional Alzheimer's disease.

"It offers a tremendous opportunity for us to answer a large number of questions, while at the same time offering these people some significant clinical help that otherwise they never would have had," Dr. Steven DeKosky, an Alzheimer's researcher says.

Some 5.4 million Americans currently have Alzheimer's disease, and those numbers are only expected to grow as the baby boom generation ages.

The study will include a small number of Americans with gene mutations guaranteed to cause early-onset Alzheimer's, part of the federal government's first national plan to address Alzheimer's disease.

Whether the Colombia trial will succeed is not a given. Many clinical trials fail, and the history of Alzheimer's research is marked by frustrating results from treatments it was hoped would be promising. The unique nature of trying a drug years before the onset of the disease is considered a promising approach to identifying what causes Alzheimer's and how to potentially prevent the disease.

The Colombia drug trial will be financed with $16 million from the National Institutes of Health, about $15 million from private donors through the Banner Institute and $65 million from Genentech, the drug's American manufacturer.

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