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Monoclonal Antibodies

Bepranemab for Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
50 to 80 years of age
Diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from from baseline to week 56 and week 80
Awards & highlights

Study Summary

This trial is testing if a new drug, bepranemab, can help people with prodromal or mild Alzheimer's Disease by improving their cognitive function.

Who is the study for?
This trial is for people aged 50-80 with mild cognitive impairment or mild Alzheimer's, as defined by specific criteria. They must have a certain level of memory function and an informant who can report on their condition. Those with other cognitive conditions, recent experimental therapy use, or certain medication histories are excluded.Check my eligibility
What is being tested?
The study tests Bepranemab against a placebo to see its effects on dementia symptoms in Alzheimer's patients over 80 weeks. It focuses on changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), which measures the severity of dementia.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions at the injection site, headaches, gastrointestinal issues, and possible immune responses due to Bepranemab being a monoclonal antibody.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 80 years old.
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I have been diagnosed with early-stage Alzheimer's Disease.
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My memory test score for recalling information was 85 or less.
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I have someone who knows me well and sees me at least 5 hours a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from from baseline to week 56 and week 80
This trial's timeline: 3 weeks for screening, Varies for treatment, and from from baseline to week 56 and week 80 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
Secondary outcome measures
Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)
Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (A-iADL)
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose level 2 bepranemabExperimental Treatment1 Intervention
Participants randomized to this arm will receive pre-specified doses (Dose level 2) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.
Group II: Dose level 1 bepranemabExperimental Treatment1 Intervention
Participants randomized to this arm will receive pre-specified doses (Dose level 1) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.
Group III: Placebo ArmPlacebo Group2 Interventions
Participants randomized to this arm will receive Placebo to maintain the blinding during the Double-blind Treatment Period and will re-randomized during the Open-label Extension Period to receive pre-specified doses of bepranemab.

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
101 Previous Clinical Trials
21,015 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
205 Previous Clinical Trials
44,542 Total Patients Enrolled

Media Library

Bepranemab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04867616 — Phase 2
Alzheimer's Disease Research Study Groups: Dose level 2 bepranemab, Dose level 1 bepranemab, Placebo Arm
Alzheimer's Disease Clinical Trial 2023: Bepranemab Highlights & Side Effects. Trial Name: NCT04867616 — Phase 2
Bepranemab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04867616 — Phase 2

Frequently Asked Questions

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

Is enrollment still open for participation in this trial?

"This clinical trial seeks 421 participants aged 50 to 80 with a confirmed diagnosis of Alzheimer's disease (AD). To be considered, individuals must have a score ≤85 on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at screening, Mini-Mental State Examination (MMSE) scores ≥20 at screening, global Clinical Dementia Rating (CDR) scores between 0.5 and 1.0 as well as CDR Memory Box Scores that are also ≥0.5 both during Screening and Baseline phases; these applicants should furthermore possess an informant who is able to maintain contact with them for 5"

Answered by AI

What adverse effects may be associated with Bepranemab treatment?

"Considering the Phase 2 status of Bepranemab, which has evidence to suggest its safety but not efficacy, we awarded it a score of 2."

Answered by AI

At how many venues is this research endeavor being conducted?

"This trial has 50 available sites, such as Ah0003 50520 in Gatineau, Ah0003 50461 in Ottawa, and Ah0003 50464 in Ocoee. Additionally there are other locations participating across the country."

Answered by AI

Is this research endeavor currently accepting participants?

"Based on the data hosted by clinicaltrials.gov, it appears that this medical trial has ceased recruiting participants at present time; The study was first posted in June 2021 and last updated November 2022. Fortunately, there are 546 other trials seeking patients currently."

Answered by AI

Is the age range for this clinical study restricted to only those under 30 years old?

"This particular clinical trial has a constraint that requires participants to be aged between 50 and 80 years old. If you are under 18, there are 23 trials available for your age group, whereas over 65 individuals can choose from 536 different studies."

Answered by AI

Who else is applying?

What site did they apply to?
Ah0003 50445
Ah0003 50448
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
2021. "A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04867616.
All > Alzheimers Disease Miami > Mild Cognitive Impairment
~12 spots leftby May 2024
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