Alzheimer's Disease Clinical Trials in Santa Monica, CA

There is a major unmet need for timely, non-invasive, and low-burden evaluation of patients presenting with mild cognitive impairment (MCI) and dementia. MCI impacts 12-18% of people in the United States over age 60 years (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022). MCI does not substantially interfere with daily activities, although complex functional tasks may be performed less efficiently (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 30% of MCI patients have Alzheimer's disease (AD) as a cause of their symptoms (Lopez,OL, Kuller LH, Becker JT, et al. Incidence of dementia in mild cognitive impairment in the cardiovascular health study cognition study. Arch Neurol. 2007;64(3):416-420.doi:10.1001/archneur.64.3.416)). In contrast, dementia is defined by chronic, acquired loss of two or more cognitive abilities caused by brain disease or injury, often associated with significant interference with the ability to function at work or at usual activities. (Knopman DS, Petersen RC. Mild cognitive impairment and mild dementia: a clinical perspective. Mayo Clin Proc. 2014;89(10):1452-1459. doi:10.1016/j.mayocp.2014.06.019). Approximately 60-80% of dementia patients have AD as a cause of their symptoms (Alzheimer's Association. Mild Cognitive Impairment (MCI) available at https://www.alz.org/alzheimers-dementia/what-is-dementia/related_conditions/mild-cognitive-impairment. Accessed August 16, 2022). Read Less

The PREVENTION Trial is a 12-month, two-arm randomized clinical trial (RCT) in adults 50-80 years old experiencing cognitive decline. Our study clinicians will refer patients for enrollment based on three categories: 1) a diagnosis of mild AD according to criteria established by the National Institute of Neurological and Communicative Disorders and Stroke (AD and Related Disorders Association [NINCDS-ADRDA]), 2) those with mild cognitive impairment will be diagnosed according to the Petersen method, and 3) subjective memory impairment as assessed by neuropsychological assessments and self-report. Enrollment will require evidence of AD pathophysiological processes (as defined by a positive amyloid positron emission tomography (PET) scan). The first objective is to evaluate the efficacy of a coached, data-driven, multi-modal lifestyle intervention to treat cognitive decline. Subjects will be randomized into one of two groups: Group 1 (Active Control) or Group 2 (Intervention). Group 1 (Data-driven clinical recommendations (CR)) will serve as the active control group and will receive data-driven clinical recommendations by a study physician based on study assessments and clinical lab values. Group 2 (Data-driven multi-modal intervention with coaching (MMIC)) will receive the same clinical recommendations and also an intensive multi-modal intervention with health coaching, support and resources to carry out these recommendations. This includes health coaching sessions (with an RDN), dietary counseling sessions (with an RDN), and group cognitive and physical exercise classes (CogFit) with a certified personal trainer and a computer-based neurocognitive program at home. Both groups will be measured for treatment related changes in cognitive and functional abilities, quality of life, biological, and biochemical measures. The second objective is to analyze longitudinal multi-omic data, including metabolomics, proteomics, genetics, microbiome, behavior and cognition into personalized, dense, dynamic data (i.e. PD3) from individuals with cognitive decline and underlying Alzheimer's neuropathology. The goal analysis is to identify models of causation that can further advance knowledge and research in neurodegenerative disorders and healthy living. Read Less