CPMC’s Ray Dolby Brain Health Center enrolls first patients into its inaugural set of leading-edge clinical trials

California Pacific CURRENTS: The online journal of CPMC Research Institute

May 26, 2016 (San Francisco, CA)

CPMC’s Ray Dolby Brain Health Center enrolls first patients into its inaugural set of leading-edge clinical trials
First clinical research studies at the Center will help lead to earlier diagnoses and more effective treatments for people with cognitive impairment, Alzheimer’s disease and dementia

New first-in-kind drug may help improve symptoms and treat decline in people with Alzheimer’s disease

As Alzheimer’s disease progresses, connections between neurons are weakened or lost, important neurochemical systems are disrupted, and brain cells die—causing cognitive impairment, memory loss, behavioral changes, and loss of functional independence. Although current medications cannot stop Alzheimer’s disease-related neuron damage, they can improve, moderate or stabilize symptoms by affecting chemicals involved in relaying messages between neurons. Clinicians often prescribe a combination of medications to treat the symptoms of Alzheimer's disease (e.g., difficulties with memory, communication, thinking, planning, reasoning, judgment, and confusion) and support daily function and behavior.

CPMC’s Ray Dolby Brain Health Center (RDBHC) is enrolling patients into an international study of a new oral experimental drug called idalopirdine, in patients with mild-to-moderate Alzheimer’s disease. Patients will be given the drug for six months in combination with currently approved medications for the illness. Changes in their cognition, daily function, and behavior will be assessed. “Phase I and II studies with the drug—which has the potential to be the first new treatment for Alzheimer’s disease in over a decade—have been very promising,” says Alireza Atri, MD, PhD, Ray Dolby Endowed Chair in Brain Health Research, RDBHC Director of Research and Education, Senior Scientist at CPMC’s Research Institute (CPMCRI), and Visiting Scientist at the Center for Brain/Mind Medicine, Brigham and Women’s Hospital, Harvard Medical School.  “The drug appears to have good safety and tolerability, and is given once-daily. This study represents the type of rigorous trial that will help advance treatment of the illness with more effective compounds used in ’cocktail‘ combinations.”

Nearly six million Americans and approximately half a million Californians are affected by Alzheimer's disease, dementia, or a related memory disorder. Without more effective future treatments to slow cognitive decline or prevent the emergence of disease-related symptoms, it is estimated that the number of affected people will triple over the next two to three decades—draining national resources and causing an epidemic of dementia.

For more information about clinical trials at the RDBHC and to find out if you or your loved one might qualify for a research study, please call Amber Lee at 415-600-5568 or by email at leeaj@sutterhealth.org.

New methods to visualize the brain and assess Alzheimer’s disease-related changes

In Alzheimer’s disease, progressive build-up of abnormal proteins, including amyloid protein ’plaques’ and tau protein ‘tangles’, at the junction of or inside neurons causes deterioration of brain function, memory, cognition, behavior, and loss of independence. The concentration of these proteins can be measured in spinal fluid obtained via a lumbar puncture procedure (i.e., spinal tap), but this does not allow visualization of their distribution in important areas of the brain. Until now, the only way for researchers to visualize plaques and tangles was by examining brain tissue during an autopsy (i.e., after a patient’s death). But cutting-edge advances in brain imaging have yielded sophisticated new PET (positron emission tomography) scans that can illuminate plaques and tangles in the brains of living patients with the illness. 

In the largest brain imaging study nationwide—called IDEAS (Imaging Dementia—Evidence for Amyloid Scanning)—clinicians and researchers will track more than 18,000 people aged 65 years and older with cognitive impairment or dementia. The goal is to determine if early identification of plaque build-up (as seen on PET scans) improves diagnostic accuracy and treatment, and reduces costs associated with the illness. Findings from amyloid PET imaging will be considered in the context of a patient’s medical history, physical examination, and cognitive testing to increase diagnostic accuracy and aid management and counseling.

CPMC’s RDBHC was one of the few sites in Northern California selected to participate in the study—a collaboration spearheaded by the Alzheimer’s Association in partnership with the Centers for Medicare & Medicaid Services (CMS), biopharmaceutical companies, academia, the American College of Radiology, and dementia subspecialists. The much-anticipated study launched last month. 

Participation in the IDEAS trial is a testament to our Center’s dedication to improving early detection and individualizing care and treatment of neurodegenerative cognitive disorders, including Alzheimer’s disease and related illnesses. Timely and accurate diagnosis is critical to the delivery of more efficient and effective care that empowers individuals with these conditions,” says Dr. Atri. “We anticipate that results of the study will improve understanding of the overlapping manifestations of Alzheimer’s disease and related conditions, reduce costly testing, and lead to more safe and effective individualized care.”

In a separate brain imaging study that uses a new imaging dye, researchers at CPMC’s RDBHC will look specifically at the build-up of tau proteins in the brains of cognitively healthy individuals with terminal illnesses, and individuals with mild cognitive impairment or dementia who are also near end of life.  Tau-PET brain scans will be compared to brain tissue obtained at autopsy, to see variations in the presence and distribution of abnormal tau protein aggregates. “We anticipate the study will provide evidence supporting the utility of Tau-PET imaging to accurately and non-invasively detect and characterize the distribution of abnormal tau protein aggregates. Ultimately, studies like this will lead to tools to help detect and differentiate Alzheimer’s disease from other conditions that cause dementia symptoms at early stages when treatments could be most effective,” says Dr. Atri.

Learn more about CPMC’s Ray Dolby Brain Health Center