Hoag Hospital’s Pickup Family Neurosciences Institute is enrolling patients in a Phase III clinical trial, TRAILBLAZER-ALZ 2, which investigates the efficacy and safety of an investigational treatment aimed at the early symptom phase of Alzheimer’s disease (AD).
The investigational treatment targets and removes deposited amyloid plaque, which is one of
the two signature markers of AD in the brain. The Phase II trial found that patients who received
the treatment scored better on tests of cognition and ability to perform daily activities than those
given a placebo.
Researchers also found a significant decrease in both amyloid and tau, the other markers of AD, on PET scans in patients who received the investigational treatment.
“This is a milestone study that speaks to the potential for long-term disease modification,” said
Gustavo Alva, M.D., DFAPA, a psychiatrist expert in cognition, who recently joined Hoag and is the principal investigator of the study. “This is a critical investigational treatment for Alzheimer’s disease and we are excited that our patients can potentially participate in this important research.”
This Phase III, double-blinded, placebo-controlled study aims to validate the early evidence that removal of amyloid plaque slows the progression of AD measured by clinical, cognitive and functional outcomes in a larger population. This study will also expand the previous Phase II trial to include patients with high tau pathology.
“It was encouraging to see the significant reduction in plaque and the slowing of cognitive decline, especially because Hoag was also a study site in the earlier Phase II trial. This suggests that amyloid and tau imaging could serve as the foundation for precision medicine-based Alzheimer’s disease treatments,” said Michael Brant-Zawadzki, M.D., F.A.C.R., Hoag’s senior physician executive and the Ron & Sandi Simon Executive Medical Director Endowed Chair of the Pickup Family Neurosciences Institute. “We are very excited to be a part of this Phase III study, which marks a huge step forward in the battle against Alzheimer’s disease.”
Alzheimer’s disease affects more than six million Americans. Without medical breakthroughs to prevent, slow or cure the disease, that number is expected to increase to 13.8 million by 2060.
“As our population ages, successful, viable treatments for Alzheimer’s disease become more important every year,” Dr. Alva said. “At Hoag we are proud to participate in the discovery and development of significant tools to change the trajectory of this debilitating disease.”
For more information on the study and the study participation, please email
clinicalresearch@hoag.org.
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