Clinical Trials

• APEX
• Memory Consultation Clinic Registry Project

APEX

Summary: Researchers will look at changes in blood tests, memory, and other factors that may predict who will accumulate brain amyloid over time, as well as factors that may help preserve memory and thinking in older individuals who do not develop elevated amyloid levels. The APEX Study consists of one in-person visit every year for four years in which blood samples, memory tests, and questionnaires will be collected. Participation in this study will help researchers identify changes in blood tests, memory, and brain health that may occur years before people develop elevated brain amyloid and cognitive impairment and inform future clinical trials for Alzheimer’s disease.

Basic Eligibility:

• NOTE: Enrollment is based solely on ineligibility from the AHEAD study through ACTC. Self-referrals are not possible for this study.
• Age: 55-80
• Previously consented to participate in the AHEAD study (now closed to enrollment)
• Other eligibility criteria: Please see study website below.

Point of Contact: Tad Kolterman, Research Associate, 757-446-7368  (KolterTE@odu.edu)

Email Contact: GlennanCenterResearchTrials@evms.edu

Study Website: https://www.actcinfo.org/trial/alzheimers-plasma-extension-study-apex/ (titled: APEX study website)

ClinicalTrials.Gov: Study Details | Alzheimer's Plasma Extension | ClinicalTrials.gov (titled: NCT06416072)

Sponsor: ACTC (Alzheimer’s Clinical Trials Consortium) funded by the National Institute on Aging and National Institutes of Health.

Memory Consultation Clinic Registry Project

Summary: The goals are the following:

• To identify patients with cognitive disorders and their care partners who are evaluated 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.
• To provide participants with information regarding potential clinical trials for which they may be interested/eligible.

Basic Eligibility:

• Age: 18+
• Cognitive Level: No restrictions on cognitive level per below:
  a. Patients with any form of dementia of differing severity, from early to late dementia.
  b. Patients with very mild memory impairment (MCI).
  c. Family members of patients. 
  d. Healthy individuals who have noticed some subjective memory loss.
  e. Healthy individuals with risk factors for developing dementia and Alzheimer’s such as:
       i. Family history
       ii. Positive genetic predispositions
       iii. Cardiovascular risk factors

Target population: Pre-Clinical (no symptoms but higher risk), Subjective Memory Complaints, Moderate, Advanced

Point of contact: Jordan Johnson, Research Assistant, 757-446-0596 (JohnsoJN@odu.edu) OR Jayne Staley, Research Assistant, 757-446-0359 (JSTALEY@odu.edu)

Email contact: GlennanCenterResearchTrials@evms.edu

Sponsor: Private donor from the Hampton Roads community

• AHEAD
• MAP

AHEAD

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 participant's brain.

Basic Eligibility: Study no longer enrolling

Target population: Pre-Clinical (no symptoms but higher risk)

Point of Contact: Katie Banko, Clinical Research Coordinator, 757-446-0358 (BankoKL@odu.edu), or Adiba Talibi, Research Assistant, 757-446-7258 (TalibiA@odu.edu).

Email Contact: GlennanCenterResearchTrials@evms.edu

Study Website: https://www.aheadstudy.org/about/ (titled: AHEAD3-45 study website)

ClinicalTrials.Gov: https://clinicaltrials.gov/ct2/show/NCT04468659 (titled: NCT04468659)

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

MAP

Summary: MAP is a research study looking at an existing drug used for diabetes prevention. The study tests if this drug can help prevent a decline in memory and thinking abilities for people with mild memory problems.

Basic Eligibility: 

• Age: 55-90
• Cognitive Level: Noticeable changes in memory
• Not currently taking Metformin
• No current diagnosis of Diabetes
• Other eligibility criteria: Please see study website below 

Point of contact: Jordan Pettaway, Research Associate, 757-446-7445 (PettawJL@odu.edu)  OR Abby McMillan, 757-446-5161 (McMillAM@odu.edu)

Email Contact: GlennanCenterResearchTrials@evms.edu

Study Website: https://www.nationalmapstudy.org/  (titled: MAP study website)

ClinicalTrials.Gov: Study Details | Metformin in Alzheimer's Dementia Prevention | ClinicalTrials.gov (titled: NCT04098666)

Sponsor: Columbia University / National Institutes of Health (NIH) through the National Institute on Aging (NIA)

• ADNI4
• START

ADNI4

Summary: The study’s goals are to improve how doctors diagnose and treat a patient with Alzheimer’s disease and to provide data to researchers around the world.

Expected Start Date: 

Basic Eligibility: 

• Age: 55-90
• Other eligibility criteria: Please see study website below

Point of contact: Brielle Schreiter, Clinical Research Coordinator, 757-446-0396 (SchreiBR@odu.edu)

Email Contact: GlennanCenterResearchTrials@evms.edu

Study Website: ADNI4 - Alzheimer’s Disease Neuroimaging Initiative Study (titled ADNI4 study website)

ClinicalTrials.Gov: Study Details | Alzheimer's Disease Neuroimaging Initiative 4 | ClinicalTrials.gov (titled NCT05617014)

Sponsor: The National Institute on Aging (NIA)

START

Summary: Through the START Study, we seek to learn if a new treatment, CT1812, can safely slow memory loss caused by Alzheimer’s disease

Expected Start Date: 

Basic Eligibility: 

• Age: 50-85
• Cognitive Level: Have a diagnosis of either mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia
• Other Eligibility Criteria: Please see study website below

Point of contact: Brielle Schreiter, Clinical Research Coordinator, 757-446-0396 (SchreiBR@odu.edu) OR  David Elkins, Clinical Research Coordinator, 757-446-5675 (Elkinsde@odu.edu)

Email Contact: GlennanCenterResearchTrials@evms.edu

Study Website: https://start-study.org/ (titled START website study)

ClinicalTrials.Gov: Study Details | A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease | ClinicalTrials.gov (titled: NCT05531656)

Sponsor: National Institute on Aging (NIA) of the National Institutes of Health (NIH)