Alzheimer’s Clinical Trials Platform
Explore This Program
Overview
The McCance Center Clinical Trials Platform (CTP) aims to accelerate the translation of compelling laboratory research into formal clinical trial development that can help patients. Our team has experience in the design, execution and clinical testing of state-of-the-art interventions ranging from small oral molecules (e.g. safe, FDA-approved drugs and natural products) to multi-domain lifestyle interventions for the prevention and treatment of Alzheimer’s disease (AD) and related disorders, including age-related cognitive decline.
Our unique clinical and translational approach:
Our CTP examines drug development, medical nutrition, and lifestyle intervention approaches to treating AD and related conditions. Our unique approach uses both cohort studies of brain aging and laboratory models of brain disease.
In these cohort studies, we apply nutrient biomarker pattern analysis to identify nutrient combinations that show synergistic characteristics. We use this information to determine which specific features of brain health are associated with each distinct nutrient combination in high-risk populations, then validate nutrient combinations associated with brain health in these diverse populations.
In our laboratory models, we first create human brain organoid models of AD and age-related brain pathology. We then conduct high throughput screening of drugs and natural products in these models, then validate these therapies in transgenic models of AD and related disorders.
Biomarker-based Phase 2 Clinical Trials
Our clinical trials are aimed at early-stage patients with AD and related disorders. We will also use blood-based and neuroimaging biomarkers to identify people without symptoms of AD who are at high risk for dementia later in life. These biomarkers of AD brain pathology help us target our novel therapies to specific populations best suited to gain benefit—a precision medicine concept. The biomarkers also allow us to carry out proof-of-concept clinical trials using blood tests to determine whether our novel therapies are reducing brain pathology of AD - beta-amyloid plaques, neurofibrillary tau-protein tangles, and neuroinflammation, cerebral small vessel disease - white matter lesions, neuronal and blood-brain barrier integrity breakdown, cerebral bioenergetic deficits - metabolic disturbances, and nutritional risk for dementia.
Alzheimer’s-in-a-Dish Screening
Over the past decade, McCance Center Director, Dr. Rudolph Tanzi and colleagues in the MGH Genetics and Aging Research Unit have pioneered revolutionary mini-human brain organoid models of AD - “Alzheimer’s-in-a-Dish™” - that have made drug screening 100 times faster and cheaper than previous methods using AD rodent models. Dr. Tanzi has used these human brain organoid models to identify over 300 safe, FDA-approved drugs and natural products that can be combined to target multiple AD brain pathologies simultaneously. These combinations are now being tested in AD clinical trials in the McCance Center Alzheimer’s Clinical Trial Initiative.
Nutrient Biomarker Screening
McCance Center Clinical Trials Director, Gene Bowman, ND, MPH, and colleagues developed a new direction in nutritional epidemiology using molecular biomarkers of nutrition (i.e., nutrient biomarkers) called NuPAN that identifies distinct combinations of nutrients and metabolites in the blood and cerebrospinal fluid that are associated with specific features of brain health, such as mental and thinking abilities, neuropathological features identified using cerebrospinal fluid, neuroimaging, or post mortem brain tissue at autopsy. This approach led to the initial effort by the National Institutes of Health and National Institute on Aging to conduct targeted clinical trials of dietary supplements in North America to prevent dementia.
The impact of lifestyle on brain health
We are advancing clinical research on lifestyle interventions to preserve and promote brain health. These studies focus on areas including sleep, stress, exercise, and diet. Learn more about lifestyle interventions here.
Dr. Bowman has joined the team as Director of Clinical Trials. His expertise uses a population-based approach focusing on specific groups with a common disease characteristic. Combining Dr. Bowman’s population approach with Dr. Tanzi’s lab results will guide the next round of McCance Clinical trials.
Services Offered
- Consultancy on clinical trial design, execution, and private-public partnerships
- Collaboration on single molecule, nutrient combinations, diet/lifestyle studies in cognitive aging and dementia
- Data Safety and Monitoring
- Nutrient and disease biomarker profiling
- Clinical and translational research design
- Improving clinical nutrition trial design
- Conducting pragmatic trials
Contact Us
- Dr. Gene Bowman: gbowman@mgh.harvard.edu
- Dr. Rudolph Tanzi: rtanzi@mgh.harvard.edu