← 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,285 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,005,012 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this research project?

"This medical study, which is hosted on clinicaltrials.gov, is currently looking for participants. The trial was first posted on November 18th 2018 and was most recently edited on April 27th 2022."

Answered by AI

Has the FDA sanctioned Cognitively unimpaired for medical use?

"While there is some evidence of safety, none exists yet for efficacy. Therefore, this study receives a 2 on our scale."

Answered by AI

What outcomes does this research hope to uncover?

"The main metric that will be used to judge the efficacy of this treatment over a two year period is the difference in ROC AUCs for patients with mild cognitive impairment or Alzheimer's disease. Additionally, secondary outcomes include measures of change in cerebrospinal fluid neurofilament light chain protein and UCB-J distribution volume ratio."

Answered by AI

How can I sign up for the clinical trial?

"This study is open to 120 people with Alzheimer's disease between the ages of 55 and 89. Most importantly, patients are required to meet the following criteria: Cognitively unimpaired adults-, Aged 55 - 89, Normal cognition (results of most recent testing with the source cohort indicate the participant is cognitively unimpaired as judged by consensus or expert review), Willing to undergo [C-11]UCB-J, [C-11]PiB, and [F-18]MK6240 PET scans, An adequate MRI exam within 12 months prior to baseline. An MRI will be performed if not already"

Answered by AI

Does this research prohibit geriatric patients from enrolling?

"This study requires that potential participants be aged between 55 and 89."

Answered by AI

How many people are the researchers testing this on?

"That is correct. The clinical trial, which was originally posted on 11/18/2018 and edited as recently as 4/27/2022, is recruiting patients at this time. They are searching for 120 participants across 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Synapse Project

2018. "The Synapse Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04871074.

All > Alzheimer Disease > Alzheimers Disease