UCB-J for Alzheimer's Disease

Palo Alto (17 mi)

Overseen byBarbara Bendlin, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Prior Safety Data

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.

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

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

I have mild memory loss or mild dementia.

I am between 55 and 89 years old.

I am 50 years old or older.

I am in good health with no conditions or medications affecting my thinking or imaging tests.

I do not have any cognitive impairments.

Exclusion Criteria

I am currently taking Levetiracetam for seizures.

I do not have any untreated serious health conditions.

I haven't had lumbar spine surgery, don't take blood thinners or immunosuppressants, and haven't been treated for an infection recently.

I am not pregnant, breastfeeding, nor planning to become pregnant.

I am unable to make decisions for myself at the time of giving consent.

Treatment Details

[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.

3Treatment groups

Active Control

Group I: Cognitively unimpairedActive Control3 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 dementiaActive Control3 Interventions

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

Group III: Mild Cognitive ImpairmentActive Control3 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.