CCBP Study synopsis:
The Cincinnati Cohort Biomarker Program was designed with the idea in mind that we need a new approach if we are ever going to properly tackle diseases of brain aging. One that gets rid of the old labels doctors have been using to diagnose these diseases so we can look for new ways that can more accurately describe what is going wrong in each individual. In this study, individuals will not be analyzed based on the diagnosis given to them at the bedside. Instead, it will be based on their biology, which will also serve to match them to therapies already available. Our goal is to find biomarkers, which are measurable indicators of the presence/severity of a particular disease, like blood glucose used to monitor people with diabetes, for example.
The purpose of this study is to identify distinct “types” of neurodegenerative diseases. This will require collecting blood, urine and stool for analyses. We will also need questionnaires, scales and devices for clinical assessments. These will measure gait, balance, cognitive function, and physical activity. The purpose of CCBP is to separate neurodegenerative diseases into biological subtypes and then match each one to therapies, many of which are already available, to slow disease progression.
In the first 5-year phase, the program will recruit 5000 people (4000 patients and 1000 healthy controls). Each person will come in annually to undergo this variety of examinations and have the samples collected. These will be examined and grouped according to relevant biological markers rather than the clinical diagnoses. This analysis will also look for matches to therapies, so that we can in the future test those therapies again in those most likely to benefit.
Our goal is to have confirmed, before the end 2029, the first therapy that slows or stops progression of a well-defined biological type neurodegeneration, be it Parkinson’s, Alzheimer’s or any other disease of brain aging.
Anyone older than 18 years of age who has either documented parkinsonian features or a diagnosis of Parkinson’s Disease, Essential Tremor, Normal Pressure Hydrocephalus, Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Freezing of Gait or Dementia (including but not limited to Alzheimer’s Dementia, Frontotemporal dementia, Parkinson’s Disease dementia, Dementia with Lewy bodies and mixed dementias) can volunteer to participate. Individuals without neurological disease are also welcome to participate; we can only include if within 5 years from the mean age of patients.
At the moment, visits are taking place at University of Cincinnati Gardner Neuroscience Institute. They can be carried out in one visit or be scheduled in two if preferred by the participant. The visits consist of an “in-clinic” part where we will do a baseline assessment and collect biological samples (blood and urine) as well as clinical and demographic data and some questionnaires. A subgroup of participants (patients as well as controls) will be also offered the possibility to undergo a brain MRI scan (50 minutes per participant, in total) without contrast. This assessment will be done at baseline and will be asked to repeat within 6 months from the follow-up visit.
Then, an “at-home” assessment will take place. It consists of giving participants a wrist-worn wearable sensor device to use for 24 consecutive hours to collect data from which estimates of sleep behavior and quality, pulse rate and stepping activity, among other things, can be derived. A questionnaire for dietary habits will also be completed by participants at home, and they will be provided with a kit and instructions for at-home stool sample collection.
A follow-up visit will take place 12 months after the first assessment and will continue on an annual basis. Procedures will be identical to baseline, with the exception of DNA analysis among the biological samples’ collection. This will only be done once, during the first visit.
There will be no cost to participants for participating in this study. Patients and healthy controls will receive $100 stipend at the end of each complete annual assessment to compensate their time and travel. For more information please contact us at: firstname.lastname@example.org.
The CCBP team.