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, Research Associate, 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: Nicole Williams, Research Assistant, 757.446.7258

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

Stress Reduction and Coping with Caregiver Burden: Group Therapy for Caregivers of Patients with Dementia Study

Primary Investigator: Hamid Okhravi, MD

Sponsor: EVMS Clinical Research Grant (CRG)

Summary: To determine the effects of psychosocial education (PE) classes (provided by Alzheimer’s Association) on caregiver burden/stress.

Point of Contact: Patricia Sandoval, MPH, Research Coordinator 757.446.5675

Additional Contact: GlennanCenterResearchTrials@evms.edu 

To be eligible, participants must be:

• Caregivers of patients with Alzheimer’s dementia who feel stressed out from emotional and physical burden.
• Available to attend one-hour meetings once per week for a total of 10 weeks, either virtually or face-to-face.

Study Duration: Group sessions are once per week either virtually or face-to-face for a total of 10 weeks.

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: Nicole Williams, 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 

A Randomized, Double-blind, Placebo-controlled, Parallel, 12-week, Phase 2a Study of Topical Pirenzepine (WST-057) or Placebo in Type 2 Diabetes Mellitus Patients

Primary Investigator:  Elias S. Siraj, MD

Explore Dr. Siraj's reasearch.

Summary: The purpose of the study is to evaluate the effects of topical Pirenzepine gel as compared with placebo gel on painful peripheral neuropathy in Type 2 Diabetes patients.

Points of contact:

• Amber Ingram MS, CCRC: IngramAM@evms.edu | 757-446-8485
• Jordan Pettaway, MS: PettawJL@evms.edu | 757-446-7445

Start date: January, 2021. Currently recruiting participants

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

• Male and females with Type 2 Diabetes Mellitus
• Between the age of 30 and 75

An Adaptive, Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Engensis in Participants with Painful Diabetic Peripheral Neuropathy

Primary Investigator:  Elias S. Siraj, MD

Explore Dr. Siraj's reasearch.

Summary: The purpose of this study is to evaluate the effects of intramuscular administration of Engensis as compared to placebo on pain in participants with painful diabetic peripheral neuropathy in the feet and lower legs.

Point of contact: Taneisha Sears, MPH: SearsTL@evms.edu | 757-446-5285

Start date: August, 2021. Currently recruiting participants

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

• Male and females with Type 1 or 2 Diabetes Mellitus
• Diagnosed with painful diabetic peripheral neuropathy in your feet and lower legs for at least 6 months

A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral Ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline

Primary Investigator:  Elias S. Siraj, MD

Explore Dr. Siraj's reasearch.

Summary: The purpose of this clinical trial is to assess whether Ladarixin compared to placebo treatment is effective in preserving pancreatic function and delaying the progression of Type 1 diabetes.

Point of contact: Taneisha Sears, MPH: SearsTL@evms.edu | 757-446-5285

Start Date: August, 2021. Currently recruiting participants

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

• Males and females aged 18-45 years, with new-onset Type 1 diabetes
• Require insulin to control blood sugars
• Must have started insulin within 100 days of enrolling in the study