Dorene Rentz, a neurology professor at Harvard Medical School, has studied Alzheimer's disease for over 30 years, and now, her husband has joined one of her biggest studies as a participant, Sumathi Reddy reports for the Wall Street Journal.
The A4 study
Rentz is working on the Anti-Amyloid Treatment in Asymptomatic Alzheimer's (A4) study, which is testing whether the drug solanezumab can slow down memory loss in patients who have increased levels of amyloid plaque—which researchers believe plays a role in the development of Alzheimer's disease—in their brains, but may experience zero or minimal signs of memory loss or cognitive decline.
Over the 4.5-year trial, 1,169 participants, who are between the ages of 65 and 85, receive infusions of either solanezumab, which is made by Eli Lilly, or a placebo.
Solanezumab failed to show improvement in previous trials conducted in patients who already had been diagnosed with and were showing signs of Alzheimer's disease. However, researchers involved in the A4 study hope the drug will prove more effective if they provide a higher dose to patients who are not yet showing symptoms of the disease.
Rentz' husband joins the study
Rentz' husband, Ray Berggren, is one of the A4 study's participants.
Rentz said she never expected her 73-year-old husband would someday be part of one of her Alzheimer's trials. But, a little over one year ago, Berggren started to experience problems with his memory.
According to Reddy, one "defining" moment occurred when Berggren's and Rentz' son asked Berggren if he could borrow the camera he had gifted Berggren a few years prior. "He had no recollection of the camera," Rentz said, even though they'd used the camera on vacation.
At first, when Berggren started showing signs of memory loss, Rentz was "like every other caregiver, with [her] head in the sand," she said. But eventually, Rentz convinced her husband to enroll in the A4 study.
Getting Berggren into the trial "wasn't easy," Reddy writes. At first, Rentz was concerned that her husband's experiences with memory loss would disqualify him from the study. However, Berggren passed the necessary cognitive tests, and PET scan results showed he had amyloid plaques in his brain.
"The bad news is [Berggren had] a positive amyloid scan. The good news is that [he] qualif[ied] for the study," Rentz said.
Rentz worked with Eli Lilly to ensure Berggren could enroll in the trial without posing a conflict of interest for Rentz. They ensured Berggren would participate at a location separate from where Rentz was working. According to Reddy, Eli Lilly declined to comment on the matter.
So, every month for the last three years, Berggren has received treatment at Boston University as part of the trial. Every three months, he participates in cognitive testing to assess his memory, speed processing, and other cognitive functions.
Neither the participants nor the researchers know whether the patients are receiving solanezumab or a placebo, and Rentz has never seen Berggren's test results.
"I've never been able to look at any of his data, nor do I want to. I don't even know if he's on the drug or not," Rentz said. But, she said, "I can't work in this field for 30 years to help find a cure for Alzheimer's disease and then not be able to help the person I love."
Implications of A4
For now, researchers are closely watching the A4 study.
"I'd like to see some clinical signal that would motivate me to be more enthusiastic about moving earlier with some of these" drugs, said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center. He added, "But it hasn't happened yet."
For instance, while amyloid plaques are considered a good predictor of Alzheimer's disease, having amyloid plaques does not necessarily mean a patient will develop the disease. "I think the A4 trial is positioned to really answer some of these questions. … If the A4 trial is negative, that will be a serious problem for the whole amyloid treatment approach," Petersen said (Reddy, Wall Street Journal, 9/23).