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A clinical trial and its ‘heroes’

A clinical trial and its ‘heroes’

by LUC RINALDI

Why you need to know about the international A4 clinical trial … and why you should participate, whether you’re in California, New York, Toronto or Melbourne. It could make the difference to your life.

Jim and Mary Lou Stanton are in no rush to leave.

Seated in beige leather recliners, the retired Newmarket, Ont., couple looks comfortable: Mary Lou battles the newspaper Sudoku puzzle, while her husband surveys the fourth-floor view of north Toronto. Only a few pieces of medical equipment around the bright room hint at why they’re here.

In the absence of these trials, we will not have new drugs and new treatments.

They’ve just finished one of their twice-monthly visits to the Toronto Memory Program, where they’re participating in one of the center’s many clinical trials researching Alzheimer’s disease.

“It’s important to do these trials, not just for myself, but for everyone up and coming,” says Mary Lou, a sprightly senior who was inspired to participate by the memory of her grandfather, who, late in life, “couldn’t remember his own name.”

The Stantons are a mild-mannered, unassuming pair, but Dr. Sharon Cohen describes them as the “heroes” of the field.

“In the absence of these trials, we will not have new drugs and new treatments,” says Cohen, director of the Toronto Memory Program, an expansive, 18-year-old clinic that houses Canada’s largest Alzheimer’s clinical trial program. “You have to go through this process.”

The ABCs of the A4 study

One of the newest of these processes underway at the Memory Program is the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Study, also known as the A4 Study. The landmark three-year study hopes to attract 1,000 cognitively healthy participants over 65 from the United States, Canada and Australia to help understand Alzheimer’s link to amyloid, an abnormal sticky protein that begins to build up in the brain at least 10 years before the disease’s symptoms manifest.

First, researchers at 60 sites, mainly in the United States, have to find as many as 10,000 volunteers to be screened for the 39-month trial – screening started in September – to get the 1,000 participants required.

It will hopefully invigorate the field, because people without symptoms can come forward.

Through monthly infusions of a drug called solanezumab and regular cognitive testing, the collaborative effort — the A4 is a $140-million joint project among the Alzheimer’s Association, the National Institute of Aging, private and philanthropic organizations — aims to both confirm that amyloid buildup is a cause of Alzheimer’s and pinpoint a way to fight those buildups.

The principal investigator fo the trial is Reisa Sperling, MD, the director of Researchers from the Center for Alzheimer Research and Treatment (CART) at Brigham and Women’s Hospital in Boston.

“The A4 study has really opened people’s eyes because it’s a bigger and different population now,” Cohen says.

“It’s younger people than those who have Alzheimer’s — people who have seen the disease in their family, who are proactive about their health and who want to know their risks… It will hopefully invigorate the field, because people without symptoms can come forward.”

That wasn’t always the case in amyloid trials, explains Joanne Lawrence, the senior clinical trials coordinator at Sunnybrook Health Sciences Centre’s memory unit, which is also a Canadian participant in the A4.

U.S. sites for A4 trials

AL Birmingham University of Alabama, Birmingham Denise Ledlow (205) 934-6223

AZ Phoenix Banner Alzheimer’s Institute Candy Monarrez (602) 839-6939

AZ Sun City Banner Sun Health Research Institute Molly Goddard (623) 832-5726

A4 clinical trial sites, C-E

CA Irvine UC Irvine – Institute for Memory Impairments & Neurological Disorders Beatriz Yanez (949) 824-3250

CA La Jolla University of California, San Diego Christina Gigliotti (858) 822-4800

CA Los Angeles University of Southern California Mauricio Becerra (323) 442-7594
CA Los Angeles University of California, Los Angeles Celine Ossinalde (310) 794-6191

CA Orange University of California – Neuropsychiatric Center Andrea Weideman (714) 456-5697

CA Palo Alto Stanford University School of Medicine Tamara Beale (650) 852-3234

CA Richmond University of California, Davis Katharine Vieira (916) 803-3066

CA San Francisco University of California, San Francisco Emmeline Chuu (415) 476-0671

CT New Haven Yale University School of Medicine Barbaralynn Moseman (203) 764-8100

DC Washington Georgetown University Erica Christian (202) 687-8800

DC Washington Howard University Saba Wolday (202) 865-7895

A4 clinical trial sites, F-I

FL Jacksonville Mayo Clinic, Jacksonville Dana Haley (904) 953-9680

FL Miami Beach Wien Center for Clinical Research Maria Greig-Custo (305) 674-2121 Ext.54480

FL Palm Beach Premiere Research Institute Daisy Acevedo (561) 845-0500 Ext.124

FL Tampa University of South Florida – Health Byrd Alzheimer Institute Kelly Rodrigo (813) 974-4904

GA Atlanta Emory University Gail Schwartz (404) 728-6395

IA Iowa City University of Iowa Karen Smith (319) 353-5158

IL Chicago Northwestern University Kristine Lipowski (312) 503-2486

IL Chicago Rush University Medical Center Karoll Meza (312) 942-2312

IN Indianapolis Indiana University Nancy McClaskey (317) 963-7429

A4 clinical trial sites, K-M

KS Kansas City University of Kansas Aiden Bondurant (913) 945-7671

KY Lexington University of Kentucky Sarah Tarrant (859) 323-1331

MA Boston Brigham and Women’s Hospital Martha Vander Vliet (617) 278-0379

MA Boston Boston University Jane Mwicigi (617) 638-5670

MD Baltimore Johns Hopkins University Sarah Woody (410) 550-9054

MI Ann Arbor University of Michigan, Ann Arbor Joanne Lord (734) 647-7760

MN Rochester Mayo Clinic, Rochester Sara Mason (507) 284-1324

MO St. Louis Washington University, St. Louis Pamela Millsap (314) 286-2363

A4 clinical trial sites, N-O

NC Winston-Salem Wake Forest University Health Sciences Erin Caulder (336) 713-8847

NE Omaha University of Nebraska Medical Center Barbara Bayer (402) 552-6005

NV Las Vegas Cleveland Clinic Lou Ruvo Center for Brain Health Michelle Sholar (702) 483-6026

NY Amherst Dent Neurologic Institute Caroline Kumm (716) 558-3492

NY New York Columbia University Ruth Tejeda (212) 305-7661

NY New York Mount Sinai School of Medicine Michael Kinsella (212) 659-8883

NY New York New York University Medical Center Brittany Cerbone (212) 263-5845

NY New York Weill Cornell Memory Disorders Program Gabriella Arth (212) 746-6580

NY Orangeburg Nathan Kline Institute for Psychiatric Research Raymundo Hernando (845) 398-5578

NY Rochester University of Rochester Medical Center Susan Salem-Spencer (585) 760-6562

OH Cleveland Case Western Reserve University Maria Gross (216) 464-6454

OK Tulsa Tulsa Clinical Research Christy Lisenbee (918) 743-2349

OR Portland Oregon Health & Science University Lisa Loree (503) 494-7615

A4 clinical trial sites, P-S

PA Philadelphia Drexel University College of Medicine Katie Rife (215) 255-7372

PA Philadelphia University of Pennsylvania Jessica Nunez-Lopez (215) 662-4379

PA Pittsburgh University of Pittsburgh Katy Zorich (412) 692-2730

RI Providence Butler Hospital Memory and Aging Program Diane Monast (401) 455-6403

RI Providence Rhode Island Hospital Kerstin Calia (401) 444-9861

SC Charleston Roper St. Francis Hospital Catherine Danner/Jessica Huggins (843) 724-2302

A4 clinical trials, T-W

TX Dallas University of Texas, Southwestern MC at Dallas Kathleen Koch (214) 648-9343

TX Houston Baylor College of Medicine Kimberley Brown (713) 798-5385

WA Seattle University of Washington Anita Ranta (206) 764-2339

WI Madison University of Wisconsin Ben Farral (608) 256-1901 Ext.11640


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