Current Clinical Trials

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

Primary Investigator: Hamid Okhravi, MD

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: Kate Romm, MS, VATL, ATC, Clinical Research Coordinator, 757.446.7406

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 AHEAD3-45 study website.
• Study link at Clinicaltrials.gov:  NCT04468659

New IDEAS: Brain Imaging Study for Memory Loss

Sponsor: American College of Radiology

Directed by: Alzheimer’s Association

Primary Investigator: Hamid Okhravi, MD

Summary: New IDEAS is a nationwide research study for people who have memory loss. The study is looking at a type of FDA-approved brain imaging called an amyloid PET scan. New IDEAS is trying to find out if your PET scan results help guide your doctor in diagnosing and treating your memory condition.

Point of Contact: Katelyn Stephens, Research Assistant, 757.446.0359

Additional Contact: GlennanCenterResearchTrials@evms.edu 

To be eligible, participants must be:

• You or a loved one has noticed some changes in your memory and thinking
• You are seeing a memory care doctor who is part of the study, and
• You have Medicare as your primary insurance

Additional Information:

• See the New IDEAS study website.
• Study link at Clinicaltrials.gov

Primary Investigator: Hamid Okhravi, MD

Sponsor: Private organization working in conjunction with researchers from Old Dominion University (ODU).

Summary: To determine whether THC-free CBD oil can help reduce the frequency and severity of agitation among participants with Alzheimer’s Disease (AD), or AD mixed with another type of dementia.

Point of Contact: David Elkins, MS, Research Coordinator, 757.446.5675

Additional Contact: GlennanCenterResearchTrials@evms.edu 

To be eligible, participants must be:

• Women and men over the age of 50
• Have a diagnosis of dementia due to AD or mixed AD with another type of dementia.
• Experience frequent agitation. Common symptoms include:
  • Restlessness; pacing back and forth
  • Feeling anxious
  • Sleeplessness
  • Aggression
  • Yelling
  • Attempting to hit or kick.
• Have a caregiver who spends at least four hours per day with the participant and supervises their care, is willing to accompany the participant to in person and remote study visits, and is willing to participate in the study.
• Memory unit patients are also eligible for the study.

Study duration: Six months (with four months active participation); includes four in-person visits and two virtual visits.

About the study: Unique because participants will be guaranteed to be on study medication (and placebo) at separate points while in the study

Study link in Clinicaltrails.gov

Primary Investigator: Hamid Okhravi, MD

Sponsor: National Institute on Aging

Summary: To determine if a study drug given as a pill can safely and effectively reduce the symptoms of agitation and aggression in people with Alzheimer's Disease.

Point of Contact: Kaitlin E. Romm, MS, VATL, ATC, Research Associate, 757.446.7406

Additional Contact: GlennanCenterResearchTrials@evms.edu 

To be eligible to participate, patients must:

• Have a diagnosis of Alzheimer’s Disease.
• Experience frequent agitation or aggression. Common symptoms include:
  • Restlessness; pacing back and forth
  • Feeling anxious
  • Sleeplessness
  • Aggression
  • Yelling
  • Attempting to hit or kick
• Have a caregiver who spends at least several hours per week with participant and supervises their care, is willing to accompany the participant to study visits, and is willing to participate in the study.

Study Duration: Six months and includes six clinic study visits and seven telephone contact visits.

Additional Information: 

• Visit the study’s website
• Study link in Clinicaltrails.gov

Primary Investigator: Hamid Okhravi, MD

Sponsor: Private donor from the Hampton Roads community

Summary: Goals are the following:

• To identify patients with cognitive disorders and their care partners who are evaluated in the clinic and are interested in participating in research projects.
• To establish a dataset of information about patients and care partners.
• To provide research participation opportunities for family members of patients with dementia or other at-risk individuals. 

Point of Contact: Katelyn Stephens, Research Assistant, 757.446.0359 OR Adiba Talibi, Research Assistant, 757.446.7258.

Additional Contact: GlennanCenterResearchTrials@evms.edu 

To be eligible, participants must be:

• Patients with any form of dementia of differing severity, from early to late dementia.
• Patients with very mild memory impairment (MCI).
• Family members of patients.
• Healthy individuals who have noticed some subjective memory loss.
• Healthy individuals with risk factors for developing dementia and Alzheimer’s such as:
  • Family history
  • Positive genetic predisposition
  • Cardiovascular risk factors

Sponsor: Optina Diagnostics

Primary Investigator: Hamid Okhravi, MD

Summary: We are interested in showing that a simple retinal scan reliably detects brain changes which could be related to Alzheimer’s Disease. This study is being conducted to demonstrate that scans of the retina correlate with Amyloid PET scans in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive decline.

Point of Contact: David Elkins, MS Research Coordinator, 757.446.5675

Additional Contact: GlennanCenterResearchTrials@evms.edu 

To be eligible, participants must be:

• Aged 50 years or older
• Individuals with reported cognitive complaint under clinical investigation by a health professional for cognitive impairment where Alzheimer’s Disease is one of the differential diagnoses
• Ability to undergo PET and MRI scans
• No ophthalmologic conditions that would prevent obtaining retinal imaging 

Additional Information:

• See the REPHRASE website, Get Involved 
• Study link at Clinicaltrials.gov: NCT05107882 

ACHIEVE - 4: A Phase 3, Open-Label Study of a Once Daily Oral GLP-1 Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes Mellitus and Obesity or Overweight at Increase Cardiovascular Risk

Primary Investigator: Dr. Elias Siraj, MD

Sponsor: Eli Lilly and Company

Summary: The study will test how safe and well the investigational medicine works for blood glucose and weight management compared with insulin therapy.

Point of contact: 

• Amber Ingram, MS, CRCC | IngramAM@EVMS.edu | 757-446-8485

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 diabetes Type 2 and take at least one medication for diabetes management.
• Have or at risk for heart disease, stroke, or other blood vessel diseases, or have kidney disease.

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: Dr. Henri Parson, PhD

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:

• Jordan Pettaway | PettawJL@evms.edu | 757-446-7445
• Abby McMillan, MS, EP-C | McMillAM@evms.edu | 757-446-5161
• Jan Patel | PatelJ1@evms.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.

Advance-HTN: A Randomized, Double-Blind, Placebo Controlled, Parallel ARm, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension

Primary Investigator: Dr. Elias Siraj, MD

Sponsor: Mineralys Therapeutics

Summary: The purpose of this study is to anlayze the efficacy of Lorundrostat (the study drug) for the treatment of hypertension in participants with uncontrolled high blood pressure (hypertension). This study is a clinical trial aimed to help contribute to research that may lead to more effective treatment options for uncontrolled blood pressure. The information obtained from the ADVANCE-HTN may help advance the treatment of future patients with uncontrolled blood pressure and will provide important information about how well people respond to the study drug being investigated. 

Point of contact: 

• Taneisha Sears, MPH | SearsTL@EVMS.edu | 757-446-5285

Start date: N/A. Currently recruiting participants thorugh June 2024.

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

• Have hypertension.
• Are currenlty taking TWO or more medications for uncontrolled hypertension.
• Are currently not working night shifts.

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: Dr. Elias Siraj, MD

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: 

• Taneisha Sears, MPH | SearsTL@EVMS.edu | 757-446-5285

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%.

A Study to Test the Efficacy and Cardiovascular Safety of BI-Dual GLP1-GCGR Agonist Compared with a Placebo in People who are Overweight/Obese with CVD or CKD and/or at Least 2 Weight-Related Complications or Risks Factors for CVD.

Primary Investigator: Dr. Elias Siraj, MD

Study Sponsor: Boehringer Ingelheim

Summary: The purpose of this study is to analyze the effects of an investigational drug on the cardiovascular safety in people who are overweight/obese. 

Point of contact: 

• Amber Ingram, MS, CRCC | IngramAM@EVMS.edu | 757-446-8485

Start date: N/A. Currently recruiting participants.

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

• Have a body mass index (BMI) of at least 27 kg/m^2
• Have CVD and/or at least 2 obesity related CV risk factors or comorbidities.
• Are not taking a GLP-1 medication.

Pathfinder 2: Evaluating the Safety and Performance of the GRAIL Multi- Cancer Early Detection Test (MCED) in an Eligible Screening Population

Primary Investigator:  Dr. Sami Tahhan, MD

Summary: The purpose of this study is to analyze the performance, impact, and efficacy of a multi-cancer early detection (MCED) test called Galleri. The test can detect up to 50 biomarkers for cancer through a simple blood draw.

Sponsor: GRAIL

Points of contact:

• Jordan Pettaway | PettawJL@evms.edu | 757-446-7445
• Abby McMillan, MS, EP-C | McMillAM@evms.edu | 757-446-5161
• Jan Patel | PatelJ1@evms.edu | 757-446-0577

Start date: 2023, currently recruiting participants.

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

• Are 50-80 years old.
• Have not been diagnosed with cancer within the last 3 years.
• Are a registered EVMS patient.

Nevro HFX™: A Post-Market, Multicenter, Prospective, Randomized Controlled Study to Evaluate Pain and
Neurological Function with 10 kHz Spinal Cord Stimulation Treatment of Chronic Intractable
Pain Associated with Diabetic Peripheral Neuropathy

Primary Investigator: Dr. Elias Siraj, MD

Sponsor: Nevro Corporation

Summary: The purpose of this study is to evaluate Nevro HFX™ as a treatment for painful diabetic neuropathy. The goal of this study is to use spinal cord stimulation (SCS) therapy for pain and neurological function improvement in patients with chronic lower limb (LL) pain associated with diabetic peripheral neuropathy, AKA painful diabetic neuropathy (PDN).

Point of contact: 

• Taneisha Sears, MPH | SearsTL@EVMS.edu | 757-446-5285

Start date: N/A. Currently recruiting participants.

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

• Are 22 years or older
• Have diabetes AND diabetic peripheral neuopathy (AKA painful diabetic europathy, PDN).
• Have PDN symptoms for at least 12 months.
• Have a HbA1c level less than or equal to 10% based on measurement at enrollment.

MAP: Metformin in Alzheimer’s Dementia Prevention

Primary Investigator: Dr. Hamid Okhravi, MD

Sponsor: National Institute on Aging

Summary: The purpose of this study is to test the efficacy of Metformin in the prevention of cognitive decline associated with Alzheimer’s dementia.

Point of contact: 

• Amber Ingram, MS, CRCC | IngramAM@EVMS.edu | 757-446-8485

Start date: N/A. Currently recruiting participants.

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

• Are diagnosed with a mild cognitive impairment (MCI).
• Are 55-90 years old.
• Have no known history of diabetes.
• Have no diagnosis of dementia based no the DSM-V criteria.
• Have sufficient vision and hearing capabilities. 

CCN020 Study

This study is evaluating how effective a nonhormonal birth control product is at preventing pregnancy. 

This may be the study for you if you are a healthy woman:

• Ages 18 to 40
• Have a steady male partner and are sexually active at least 4 times per month
• Willing to use the study product as your only birth control method for a year (13 cycles)

CCN021 Study

This may be the study for you if you are a healthy woman:

• Ages 18 to 40
• Not pregnant or planning to become pregnant in the next 6 months
• Sexually abstinent or use a non-hormonal form of birth control

Cervical Mucus Study

This study may be for women who:

• Are 18-50 years old
• Are HIV negative
• Have regular menstrual cycles
• Willing to give cervical mucus samples
• Meet additional study criteria

MATRIX-001 Study

This study may be for women who:

• Are 18-50
• Protected against pregnancy (abstinence, birth control, tubal ligation, same sex partner, etc.)
• Are HIV-negative
• Meet additional study criteria