← Back to Search

UCB-J for Alzheimer's Disease

Phase 2

Waitlist Available

Led By Barbara Bendlin, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to undergo [C-11]UCB-J, [C-11]PiB, and [F-18]MK6240 PET scans

Mild dementia and amnestic Mild Cognitive Impairment

Must not have

Current use of the anti-seizure medication Levetiracetam, also known as Keppra, Spritam or Roweepra

Evidence of unstable or untreated clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will use PET scans to track the progression of Alzheimer's disease by measuring the amount of amyloid, tau, and SV2A present in the brain.

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

Potential side effects are not explicitly listed for [C-11]UCB-J; however, general risks may include discomfort at injection site or allergic reactions to tracers used in PET scans. As this is an imaging study using PET scans rather than drug treatment trials, fewer direct medication-related side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I have mild memory loss or mild dementia.

Select...

I am between 55 and 89 years old.

Select...

I am 50 years old or older.

Select...

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

Select...

I do not have any cognitive impairments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking Levetiracetam for seizures.

Select...

I do not have any untreated serious health conditions.

Select...

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

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amyloid positivity status differences in annual rate of change in UCB-J DVR

Annual rate of change in UCB-J DVR

Baseline diagnosis group differences in annual rate of change in UCB-J DVR

+4 more

Secondary study objectives

APOE4 allele status differences in annual rate of change in UCB-J DVR

Age differences in annual rate of change in UCB-J DVR

Difference between ROC AUCs (MCI/AD vs CU) for MTL UCB-J DVR and cerebrospinal fluid (CSF) T-tau

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 11Eligibility criteria met