Current Clinical Trials

Sponsor: The National Institutes of Health (NIH), in partnership with the pharmaceutical company Eisai

Primary Investigator:

Summary: During the early stages of Alzheimer's disease, amyloid protein forms plaques in the brain. The AHEAD study is a Phase 3 clinical trial that will test whether the study drug, Lecanemab (BAN2401), reduces brain amyloid buildup in people with increased risk of Alzheimer's disease. Study participants will be enrolled in one of two AHEAD trials based on whether they have intermediate or elevated levels of amyloid in their brain. Participants with intermediate amyloid (A-3) will receive BAN2401 (Lecanemab) or placebo once every four weeks via infusion for four years. Participants with elevated amyloid (A-45) will receive BAN2401 (Lecanemab) or placebo once every two weeks for about two years and then once every four weeks for the remainder of the study. At different points in the study, participants will have a positron emission tomography (PET) brain scan. A PET scan takes pictures of the brain, allowing researchers to see and track changes in the amount of amyloid and tau in a participants brain.

Point of Contact: Katie Banko, Clinical Research Coordinator, 757-446-0358, or Adiba Talibi, Research Assistant, 757-446-7258.

Additional Contact: GlennanCenterResearchTrials@evms.edu

To be eligible, participants must be:

• Male or Female, age 55-80 (inclusive)
• Patients 55 to 64 years of age must have one of the following risk factors for Alzheimer's disease:
  • First-degree relative diagnosed with dementia before age 75, or
  • Known to have at least one apolipoprotein E4 variant (AP0E4) allele, or
  • Known before screening to have elevated brain amyloid according to previous PET or cerebrospinal fluid testing, or
  • Individuals with past amyloid PET scans showing intermediate brain amyloid are eligible to be screened for this study, as long as the participant did not participate in any clinical studies involving anti-amyloid therapies after the PET scan
  • Have not been diagnosed with Alzheimer's disease or another dementia
  • Have a study partner who is willing to participate as a source of information and has approximately weekly contact with the patient (in-person, telephone, or electronic communication); however, sufficient contact such that the study investigator feels the study partner can provide meaningful information about the patient's daily function
  • Willing and able to comply with all aspects of the protocol
  • Additional inclusion criteria to be determined prior to enrollment

Additional Information:

• See the .
• Study link at Clinicaltrials.gov:

Reducing diabetes distress in Adults with newly diagnosed Type 2 Diabetes:
A Pilot Study

Primary Investigator:

Sponsor: EVMS

Summary: To study the efficacy of a virtual health coaching intervention VS. standard of care on reducing diabetes distress in newly Dx diabetics.

Point of contact:

• Abby McMillan | McMillAM@EVMS.edu (or odu.edu) | 757-446-5161

Start date: N/A. Currently recruiting and enrolling participants.

Eligibility: You may be eligible to participate in this study if you:

• Have Type 2 Diabetes diagnosis within the last 12 months.
• Have access to a mobile device, tablet, desktop for virtual education and/or health coaching.
• Registered patient of EVMS.

FINE-One: A Parallel-Group, Randomized, Prospective, Interventional, Double-Blind, Multicenter Global Phase 3 Study To Investigate The Efficacy And Safety Of Finerenone Versus Placebo, In Addition To Standard Of Care, In Participants With Chronic Kidney Disease And Type 1 Diabetes

Primary Investigator:

Sponsor: Bayer

Summary: The purpose of this study is to look at the efficacy and safety of the investigational drug, Finerenone versus a placebo (in addition to standard of care) in participants with chronic kidney disease and type 1 diabetes.

Point of contact:

• Anna Stoiber, MPH, BSN, RN | StoibeAM@EVMS.edu (or odu.edu) | 757-446-8477

Start date: N/A. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Are 18 years or older.
• Have TYPE 1 diabetes.
• Have chronic kidney disease (CKD).
• Have a HbA1c less than 10%.

Primary Investigator:

Summary: To study the efficacy and safety of the current hard gelatin capsule formulation of NRD135S.E1 in the treatment of PDPN.

Sponsor: Harvard 91¶ÌÊÓƵ and the NIH

Points of contact:

• Jordan Pettaway, MS | PettawJL@evms.edu (or odu.edu)| 757-446-7445

Start date: N/A. Currently recruiting and enrolling participants.

Eligibility: You may be eligible to participate in this study if you:

• Have a body mass index (BMI) 40 kg/m^2.
• Have Type 2 Diabetes.
• Have chronic DPNP.

Nutritional Lifestyle-based Study: Impact Of A Culturally Tailored, Personalized, Mobile Health-Based Lifestyle Intervention In Improving Metabolic Outcomes Of Overweight And Obese African Americans With Prediabetes In Underserved Communities Of Southeastern Virginia

Primary Investigator:

Sponsor: American Diabetes Association (ADA)

Summary: The purpose of this study is to identify effective and sustainable dietary lifestyle interventions for African American communities in Southeastern Virginia and to assess the efficacy of a culturally tailored mobile Health-based lifestyle intervention. The goal is to determine if a personal nutrition program can help you eat healthier without giving up your favorite flavors and your cultures' cuisines/cooking.

Point of contacts:

• Jan Patel | PatelJ1@evms.edu (or odu.edu)| 757-446-0577

Start date: 2024. Currently recruiting participants.

Eligibility: You may be eligible to participate in this study if you:

• Self identify as an African American
• Are 25-55 years old.
• Are diagnosed with Pre-diabetes and/or at risk for type 2 diabetes.
• Have a body mass index (BMI) between 25-40kg/m^2.