Current Brain Health Clinical Trials & Research Studies

Clinical Trials and ResearchCurrent Clinical Trials

Translating extraordinary scientific and technological advances occurring in medical research laboratories into providing exceptional care for our patients.

Our current clinical trials are looking at new ways to prevent, detect, or treat disease leading to lifesaving cures.

Alzheimer’s Disease and Mild Cognitive Impairment

  • Alzheimer’s Disease (AD)/Mild Cognitive Impairment (MCI): The PREVENTION trial (Precision Recommendations for Environmental Variables, Exercise, Nutrition and Training Interventions to Optimize Neurocognition)  will have extensive clinical applicability. This one-year randomized controlled trial will test the efficacy of a clinical precision medicine multimodal therapy program in older adults with cognitive impairment and underlying Alzheimer’s disease pathology. We will compare one group which will receive clinical care with clinical recommendations to improve their cognitive functioning based on their unique biological, cognitive and behavioral factors with another group which will receive a comprehensive intervention program that provide them with an individually-tailored exercise, nutrition, environmental risk reduction, and cognitive training program along with a brain health coaching to support them in their lifestyle modification program. This study will provide critical data on the efficacy of controlled underlying mechanisms that promote cognitive stability or improvement. A central component to this trial will test the efficacy of our novel physical exercise program, CogFit, which is a movement-based neurocognitive training program intended to increase participation in physical activity maximize the benefits of the two cognitively-enhancing modalities. In keeping with our core mission of providing accessible and leading-edge services to improve patient’s lives we will also conduct a home-based RCT which tests the efficacy of a mobile-technology based simultaneous exercise and memory training program to improve cognitive functioning and underlying putative biomarkers in older adults with MCI. Download pdf flyer.
  • AD: Stemedica Cell Technologies’ protocol STEM105-M-AD: A phase 2A, multi-center, randomized, single-blind, placebo-controlled, crossover study to assess the safety, tolerability, and preliminary efficacy of a single intravenous dose of allogeneic human mesenchymal stem cells to subjects with mild to moderate dementia due to Alzheimer’s disease. Download pdf flyer
  • AD: Novel approaches to diagnosing & predicting progression through big data: We will develop a comprehensive biomarker dataset and collaborate on a larger data repository with other Alzheimer’s prevention clinics to collect deep phenotypic data to identify the core features of Alzheimer’s disease to aid in early risk detection.
  • MCI: Mobile technology-based simultaneous aerobic exercise and memory training intervention for older adults with mild cognitive impairment (MCI): Movement based cognitive training program to improve memory functioning in patients with subjective memory concerns or mild cognitive impairment.
  • Fall Prevention: This comprehensive ball and fall prevention program within the PBHC clinic will collect longitudinal data on its efficacy to reduce falls in older adults.

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Psychedelic-Assisted Therapy

Psychedelic-assisted therapy is an innovative and groundbreaking approach that has the potential to revolutionize the treatment of behavioral, mental health, and substance use disorders. Currently in the United States early clinical trials are underway testing a variety of psychedelic drugs including psilocybin, the active ingredient of “magic mushrooms,” MDMA (“ecstasy”), and ketamine, for a diverse range of indications including Major Depressive Disorder, Post-Traumatic Stress Disorder, and alcohol and substance use disorders.

Clinical trials of psychedelic-assisted therapies for depression and substance use disorder will be available at the Pacific Brain Health center in early 2020. The Pacific Treatment & Research In Psychedelics (TRIP) Program is dedicated to the development of psychedelic-assisted therapies and the scientific exploration of how altered states of consciousness can be harnessed to change behavior and improve health. Psychedelic-assisted therapy involves administering a psychedelic drug to a patient under clinical supervision with the purpose of triggering an altered state of consciousness to produce rapid, profound, and sustained changes in insight, mood, and behavior.

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Movement Disorders

  • Neflamapimod in Patients with Lewy Body Dementia
    A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB).
  • The INSYTE Study for Parkinson’s Disease
    To examine the current disease progression of Parkinson’s disease psychosis (PDP), the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers (NCT03152292).

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Stroke and Traumatic Brain Injury (TBI)

  • STROKE: John Wayne Cancer Institute’s JWCI-18-0701: Expanded access treatment protocol of a single intravenous dose of allogeneic mesenchymal bone marrow cells for subjects with neurologic disorders
  • STROKE: Microtransponder’s protocol MT-St-03: A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB). Download pdf flyer
  • STROKE: Bioness’s protocol STMR-PAIN-002_PSSP: StimRouter™ Neuromodulation System: Implanted peripheral nerve stimulation for pain management when treating patients with chronic post-stroke shoulder pain

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Recruitment Complete

  • STROKE: Sunovion & Sanbio’s protocol SB-STR02: A double-blind, controlled phase 2B study of the safety and efficacy of modified stem cells (SB623) in patients with chronic motor deficit from ischemic stroke
  • TBI: Sanbio’s protocol TBI-01:A double-blind, controlled phase 2 study of the safety and efficacy of modified stem cells (SB623) in patients with chronic motor deficit from traumatic brain injury
  • The PROSPECT Trial for Essential Tremor / CALA Health
    This is an open-label study of the Cala TWO device with home usage for 3 months to assess for duration of effect over the course of the trial. The device is a non-invasive peripheral neurostimulator for essential tremor and the study is open to patients with mild, moderate, and severe essential tremor.

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Research Registry

If you wish to participate in any of our current studies or if you are interested in a research study but don’t currently see one that suits you, please join our research registry to be placed on a list for future studies.

Sign Up | Brain Health Center Registry

  • Please provide us with information regarding your diagnosis, the name of the clinical trial you would like to participate in, and any other information that may help us understand your health status.