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BUSM shares $25 million from NIH to launch seven-year study of Alzheimer's

By Brian Fitzgerald

Apollo VII astronaut Walter Cunningham remembers what it was like to see his mother forget. First, she hid objects in her house and couldn't recall where she put them. She blamed her daughter for stealing the items. Then she would speak of his brother, Ken, who had died in a plane crash 37 years earlier.

"When is Kenny coming home?" she would ask Cunningham.

	Apollo VII astronaut Walter Cunningham. Photo by Linda Haas

At a January 29 luncheon at the BU School of Medicine, Cunningham spoke about the cruelty of Alzheimer's disease (AD), which causes a progressive, irreversible decline in mental functioning. It affects four million Americans as well as countless relatives and friends, who experience the agony of watching a loved one lose the ability to speak, read, and even recognize family members.

"Like a thief, it slips in slowly, and takes the things that are the most valuable," said Cunningham.

The luncheon, which marked the launch of a massive seven-year drug study for prevention of AD, featured speakers who told heartbreaking stories about the devastating effects of the disease. Journalist Charles Pierce, author of Hard to Forget: An Alzheimer's Story (Random House, 2000), talked about his father's experience with AD, which also claimed his father's three brothers. Their only other sibling, a sister, was diagnosed with Alzheimer's in 1999.

Congressman Edward Markey (D-Mass.), whose mother had the disease, points out that AD is poised to devastate the aging baby boomer population. In fact, it is estimated that without a way to prevent it, up to 10 million Americans will have AD by the middle of the next century. "That is unacceptable," said Markey, who has formed a bipartisan task force on Alzheimer's. "We've got to find a way to make sure that the next generation is not beset by this epidemic."

One start may be the $25 million Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT), a National Institutes of Health-funded clinical trial that has begun at BUSM and three other medical centers in the United States: Johns Hopkins University, the Sun Health Research Institute, in Phoenix, Ariz., and the University of Rochester. The study will test the use of anti-inflammatory medication for the prevention of AD.

Some researchers believe that inflammatory processes in the brain may play a role in the development of AD. The ADAPT study is designed to test naproxen (Aleve) and celecoxib (Celebrex), two drugs used to treat arthritis, for their ability to prevent AD. These medications, which reduce inflammation in joints and other parts of the body, may also reduce inflammatory processes in the brain.

Recent studies indicate that people who take anti-inflammatory medications to treat arthritis may have less chance of developing AD compared to people who do not take these medications. ADAPT "will help us find out whether anti-inflammatory medications can really prevent or delay the onset of Alzheimer's disease," said MED Associate Professor of Neurology Robert Green, Boston site director of the ADAPT study and clinical director of BUSM's NIH-funded Alzheimer's Disease Center. "Since these medications can have serious side effects, and since it is not yet known whether they work for Alzheimer's disease or not, no one should take them for this purpose outside of the clinical trial."

AD strikes 6 percent of people over age 65 and at least 30 percent of those over age 85, including President Ronald Reagan. Pierce's father disappeared after leaving to buy flowers for a family grave one day 16 years ago, when he was 70. "My wife called the police, and they told her that old men that age tend to run off with their secretaries," he said. Three days later he was informed that his father had run out of gas in Montpelier, Vt., 250 miles from his Massachusetts home. Because he was unable to remember his name or phone number, the Montpelier Police thought he was intoxicated. Pierce points out that there is much more public awareness of AD today, but there still is no cure.

Green said that people over 70 who have a close relative with AD are at increased risk of developing the disease. Still, if the onset of AD can be delayed by 5 or 10 years, the incidence would be reduced. Reacting to the announcement of the ADAPT study, Pierce said, "I am a lot more optimistic for my children, and I'm a lot more optimistic for myself."

Study participants must be 70 years or older by the close of the study's enrollment period in 2002 and have a mother, father, sister, or brother who has or had serious age-related memory loss, dementia, senility, or AD. Participants themselves cannot have been diagnosed with dementia, senility, or Alzheimer's disease.

Over the next 18 months, the study seeks to enroll a total of 2,600 volunteers, who will be paid a small stipend. They will be asked to take a prescribed dose of naproxen, celecoxib, or a placebo twice a day for five to seven years. The participants will meet with a study team member for medical evaluation three times the first year and twice yearly after that. They will also be interviewed twice a year by telephone. "Because there are known risks -- some serious -- with the use of anti-inflammatory medicines, it is important that people taking them have close medical supervision and monitoring," said Sanford Auerbach, BUSM associate professor and codirector of ADAPT's Boston site. "Participating in a controlled clinical trial like ADAPT is an excellent way to receive such clinical monitoring."

The study medication and all medical evaluations will be provided free of charge. Those interested in learning more about ADAPT should call 617-638-5425 or toll free at 1-866-2-STOP-AD (1-866-278-6723).

2 February 2001
Boston University
Office of University Relations