Bepranemab for Alzheimer's Disease (AD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Alzheimer's Disease (AD)+1 More
Bepranemab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • Alzheimer's Disease (AD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: From from Baseline to Week 56 and Week 80

Week 152
Incidence of Drug-related TEAEs
Incidence of TEAEs leading to discontinuation or death
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent serious adverse events (TESAEs)
Week 80
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)
Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score
Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET)
Week 80
Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
Serum concentrations of bepranemab over the 80-week Double-blind Treatment Period

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Dose level 2 bepranemab
1 of 3
Dose level 1 bepranemab
1 of 3
Placebo Arm
1 of 3

Experimental Treatment

Non-Treatment Group

421 Total Participants · 3 Treatment Groups

Primary Treatment: Bepranemab · Has Placebo Group · Phase 2

Dose level 2 bepranemab
Biological
Experimental Group · 1 Intervention: Bepranemab · Intervention Types: Biological
Dose level 1 bepranemab
Biological
Experimental Group · 1 Intervention: Bepranemab · Intervention Types: Biological
Placebo ArmPlaceboComparator Group · 2 Interventions: Placebo, Bepranemab · Intervention Types: Other, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from from baseline to week 56 and week 80

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
83 Previous Clinical Trials
20,263 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273 (UCB)
186 Previous Clinical Trials
43,049 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a mini-mental state examination score of 20 or higher.
You have at least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.