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ENVISION: A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants with Alzheimer’s Disease

Sponsor: Biogen, MA, Inc.

Primary Investigator: Hamid Okhravi, MD

Summary: The ENVISION study is a Phase 3b/4 clinical trial to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer’s disease, (including those with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia).

Aducanumab was approved by the FDA in June 2021 as a treatment for Alzheimer’s disease under the accelerated approval pathway based on aducanumab's reduction in brain amyloid coupled with evidence that reduction in brain amyloid is reasonably likely to predict clinical benefit in Alzheimer’s disease. Consistent with the accelerated approval regulations, this study is being conducted to fulfill a post-marketing requirement from the FDA to verify the clinical benefit of aducanumab.

Qualifying study participants will be randomized in a 2:1 ratio to receive either aducanumab, up to 10 mg/kg or a placebo comparator. The total duration of this study for each participant will be approximately 130 weeks, including a series of screening visits within 8 weeks before administration of the first dose, and a 104-week placebo-controlled treatment period. The investigational product (IP) will be administered monthly throughout the treatment period as an intravenous line (IV) infusion. Participants will additionally undergo a safety follow-up visit 18 weeks after the final dose of aducanumab.

Point of Contact: Brielle R. Schreiter, MS Clinical Research Coordinator & ACTC Site Liaison.

Additional Contact: GlennanCenterResearchTrials@evms.edu

Key Inclusion Criteria (partial list):

  • Male or Female, age 60-85 (inclusive)
  • The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET.
  • The participant must have a history of confirmed subjective memory decline with gradual onset and slow progression over the 6 months before screening.
  • The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time.
  • Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE ε4 carriers).

Key Exclusion Criteria (partial list):

  • Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening.
  • Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to screening.
  • History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product.
  • Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to screening unless documentation of receipt of placebo is available.
  • Use of any investigational drug.
  • Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab).

Additional inclusion/exclusion criteria to be determined prior to enrollment

Additional Information:

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:

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:

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: 

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: