What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and NMDA receptor antagonist (memantine). Side effects of cholinesterase inhibitors often include gastrointestinal issues such as nausea, vomiting, and diarrhea, as well as muscle cramps and fatigue. Memantine can cause dizziness, headache, confusion, and constipation. Anti-tau antibodies like Bepranemab are still under investigation, but potential side effects may include infusion-related reactions, such as headache, fever, and chills, similar to other monoclonal antibody treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily targeting amyloid-beta proteins. Notable examples include Aducanumab, which targets amyloid-beta oligomers and plaques, and was approved despite mixed clinical trial results. Other similar treatments in clinical trials include Solanezumab, Crenezumab, and Gantenerumab, which target different forms of amyloid-beta. While these treatments focus on amyloid-beta, Bepranemab is an anti-Tau antibody, representing a different approach by targeting tau proteins involved in neurofibrillary tangles, another hallmark of Alzheimer's pathology.

What other types of research exist?

Promising novel alternatives to Bepranemab for Alzheimer's Disease patients in 2024 include: 1) Lecanemab and Donanemab, which are amyloid-beta targeting antibodies; 2) BIIB092, another tau-directed monoclonal antibody; 3) ALZ-801, an oral agent targeting amyloid-beta oligomers; and 4) Neuroinflammation modulators like AL002, targeting TREM2. These treatments are in various stages of clinical trials and show potential in modifying disease progression.

← Back to Search

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)

Must not have

Use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening

Previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from from baseline to week 56 and week 80

Summary

This trial is testing bepranemab, a new medication, to see if it can help people with early-stage Alzheimer's disease. The study focuses on individuals who are just starting to show symptoms or have mild symptoms. Bepranemab works by removing harmful proteins from the brain that are linked to Alzheimer's.

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.

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.

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

Select...

I am between 50 and 80 years old.

Select...

I have been diagnosed with early-stage Alzheimer's Disease.

Select...

My memory test score for recalling information was 85 or less.

Select...

I have someone who knows me well and sees me at least 5 hours a week.

Exclusion Criteria

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

Select...

I haven't used any experimental treatments in the last 6 months.

Select...

I haven't taken medication for a brain disorder other than Alzheimer's in the last year.

Select...

I haven't had treatments like monoclonal antibodies or blood products in the last 3 months or 5 half-lives.

Select...

I am not on daily medication for mental health, pain, or sleep that affects my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from from baseline to week 56 and week 80

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

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

Primary study objectives

Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score

Secondary study objectives

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Alzheimer's Disease primarily target amyloid plaques and tau tangles, which are hallmark features of the disease. Cholinesterase inhibitors (e.g., donepezil, rivastigmine) work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, thereby temporarily improving symptoms. NMDA receptor antagonists (e.g., memantine) help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Anti-amyloid treatments aim to reduce amyloid-beta plaques, though their clinical efficacy has been mixed. Anti-Tau antibodies, like Bepranemab, target tau protein tangles, which disrupt neuronal function and contribute to cognitive decline. By preventing tau aggregation, these treatments aim to slow disease progression, offering hope for more effective management of Alzheimer's Disease.

Learning from the Past: A Review of Clinical Trials Targeting Amyloid, Tau and Neuroinflammation in Alzheimer's Disease.