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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
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I am willing to have specific PET scans for my condition.
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I have mild memory loss or mild dementia.
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I am between 55 and 89 years old.
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I am 50 years old or older.
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I am in good health with no conditions or medications affecting my thinking or imaging tests.
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I do not have any cognitive impairments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking Levetiracetam for seizures.
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I do not have any untreated serious health conditions.
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I haven't had lumbar spine surgery, don't take blood thinners or immunosuppressants, and haven't been treated for an infection recently.
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I am not pregnant, breastfeeding, nor planning to become pregnant.
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I am unable to make decisions for myself at the time of giving consent.

Timeline

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 Control1 Intervention
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 Control1 Intervention
Abnormal cognitive status of dementia as judged by consensus or expert review using NIA-AA 2018 criteria.
Group III: Mild Cognitive ImpairmentActive Control1 Intervention
Abnormal cognitive status of MCI as judged by consensus or expert review using NIA-AA 2018 criteria.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,225 Previous Clinical Trials
3,168,550 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,782 Previous Clinical Trials
28,183,991 Total Patients Enrolled
Barbara Bendlin, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

Cognitively unimpaired Clinical Trial Eligibility Overview. Trial Name: NCT04871074 — Phase 2
Alzheimer's Disease Research Study Groups: Cognitively unimpaired, Mild dementia, Mild Cognitive Impairment
Alzheimer's Disease Clinical Trial 2023: Cognitively unimpaired Highlights & Side Effects. Trial Name: NCT04871074 — Phase 2
Cognitively unimpaired 2023 Treatment Timeline for Medical Study. Trial Name: NCT04871074 — Phase 2
~15 spots leftby Nov 2025
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