UCB-J for Alzheimer's Disease

Overseen By Mary-Elizabeth Pasquesi

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Levetiracetam

Disqualifiers: Pregnancy, Alcohol abuse, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

102 Participants Needed

Trial Summary

What is the purpose of this trial?

The overarching goal of this project is to use \[C-11\]UCB-J to obtain spatial information on neuronal synapse abundance and inform Alzheimer's disease (AD) progression. The investigators propose to collect longitudinal amyloid, tau, and Synaptic vesicle glycoprotein 2A (SV2A) positron emission tomography (PET) in participants in the Wisconsin Alzheimer's Disease Research Center (ADRC) and Wisconsin Registry for Alzheimer's Prevention (WRAP) across the clinical stages of AD, including cognitively unimpaired biomarker negative, unimpaired biomarker positive, mild cognitive impairment (MCI), and dementia due to AD.

Research Team

Barbara Bendlin, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for adults aged 50-89 with Alzheimer's Disease, ranging from normal cognition to mild dementia. Participants must be willing to undergo specific PET scans and have a recent MRI. Exclusions include pregnancy, substance abuse history, major psychiatric disorders, MRI-incompatible implants, or conditions that could affect cognition or study completion.

Inclusion Criteria

Normal cognition (results of most recent testing with the source cohort indicate the participant is cognitively unimpaired as judged by consensus or expert review)

I am willing to have specific PET scans for my condition.

I have mild memory loss or mild dementia.

Exclusion Criteria

I am currently taking Levetiracetam for seizures.

Psychiatric disorders that may interfere with the study including current major Axis I DSM-V disorders including but not limited to severe Major depression, current or history of bipolar I disorder, or schizophrenia

Stable, treated chronic medical conditions like hypertension, hypercholesterolemia, diabetes mellitus, non-metastatic dermatologic or prostatic cancer, etc. are acceptable as long as they do not, in the study investigator's opinion, contribute to cognitive dysfunction or limit participation in study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial PET imaging and cognitive assessments are conducted to establish baseline measurements

1-2 weeks

1 visit (in-person)

Longitudinal Imaging

Participants undergo repeat PET imaging to assess synapse loss and cognitive decline over time

2 years

Multiple visits (in-person) over 2 years

Follow-up

Participants are monitored for changes in cognitive function and synaptic density

6 months

Treatment Details

Interventions

• UCB-J

Trial Overview [C-11]UCB-J is being tested in The Synapse Project to track neuronal synapse density and understand Alzheimer's progression. Participants will receive longitudinal amyloid, tau, and SV2A PET imaging across various stages of cognitive impairment within the Wisconsin Alzheimer's research cohorts.

Participant Groups

Group I: Cognitively unimpaired Active Control 3 Interventions

Results of most recent testing with the source cohort indicate the participant is cognitively unimpaired as judged by consensus or expert review.

Group II: Mild dementia Active Control 3 Interventions

Abnormal cognitive status of dementia as judged by consensus or expert review using NIA-AA 2018 criteria.

Group III: Mild Cognitive Impairment Active Control 3 Interventions

Abnormal cognitive status of MCI as judged by consensus or expert review using National Institute of Aging and Alzheimer's Association (NIA-AA) 2018 criteria.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+