Bepranemab for Alzheimer's Disease

No longer recruiting at 137 trial locations

Overseen By UCB Cares

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UCB Biopharma SRL

Must not be taking: Atypical antipsychotics, Opiates, Benzodiazepines, others

Disqualifiers: Alcohol/drug abuse, Experimental therapy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, bepranemab, to determine its effectiveness in helping people with early-stage Alzheimer's disease. Researchers aim to find out if the drug can slow symptom progression compared to a placebo. Participants will be divided into groups to receive varying doses of bepranemab or a placebo. The trial seeks individuals diagnosed with mild memory issues due to Alzheimer's. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as atypical antipsychotics, opiates, opioids, benzodiazepines, barbiturates, hypnotics, or any medication with significant antihistamine or anticholinergic effects. If you are on these medications, you may need to stop them before participating.

Is there any evidence suggesting that bepranemab is likely to be safe for humans?

Research has shown that bepranemab may help treat early Alzheimer's disease by slowing the buildup of tau proteins in the brain, a key factor linked to the progression of the disease.

For safety, researchers have tested bepranemab to assess its tolerability and potential side effects. Results are promising, indicating that most patients tolerate bepranemab well.

Specific numbers on side effects are not provided here, but the treatment is currently in Phase 2 of clinical trials. This phase involves more participants than earlier stages and focuses more on safety. By this point, researchers have gathered evidence suggesting that the treatment is reasonably safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Bepranemab is unique because, unlike most Alzheimer's treatments that focus on managing symptoms, it targets amyloid-beta plaques, which are believed to play a key role in the disease's progression. This monoclonal antibody treatment is designed to bind to these plaques and potentially slow or even halt the disease's advancement. Researchers are excited about bepranemab because targeting the underlying pathology of Alzheimer's offers a promising new approach that could lead to more effective long-term outcomes compared to current symptomatic treatments.

What evidence suggests that bepranemab might be an effective treatment for Alzheimer's Disease?

Research has shown that bepranemab may help treat Alzheimer's Disease. In earlier studies, bepranemab slowed memory and thinking problems by 21-25% compared to a placebo (a pill with no active drug). It also reduced the buildup of tau, a protein linked to Alzheimer's, in the brain. However, some findings noted that it did not significantly change the overall course of the disease. While results are mixed, the treatment shows potential in slowing certain aspects of Alzheimer's. Participants in this trial will receive either Dose level 1 or Dose level 2 of bepranemab, or a placebo, to further evaluate its effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

UCB Cares

Principal Investigator

001 844 599 2273 (UCB)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 50 and 80 years old.

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

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

Exclusion Criteria

You have health conditions that prevent you from having a PET scan.

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

I have a condition affecting my thinking or memory not caused by Alzheimer's.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either bepranemab or placebo to evaluate efficacy, safety, and tolerability

80 weeks

Open-label Extension

Participants may opt into continuation of treatment with bepranemab long-term

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bepranemab

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose level 2 bepranemab Experimental Treatment 1 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 bepranemab Experimental Treatment 1 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 Arm Placebo Group 2 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.

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials

118

Recruited

23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Citations

1. ucb.com ucb.com/newsroom/press-releases/article/ucb-presents-encouraging-data-on-bepranemab-in-early-alzheimer-s-disease-in-phase-2a-study-at-ctad-2024

UCB Presents Encouraging Data on Bepranemab in Early ... Slowed cognitive decline by 21-25% versus placebo - the change between Baseline and Week 80 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS ...

2. neurologylive.com neurologylive.com/view/assessing-phase-2-data-bepranemab-effect-tau-accumulation-cognitive-function-matthew-barton

Assessing Phase 2 Data on Bepranemab's Effect on Tau ... Despite these results, bepranemab demonstrated a significant improvement in the change between baseline and week 80 in the Alzheimer's Disease ...

3. nature.com nature.com/articles/d41573-024-00180-7

Anti-tau antibody stumbles in phase II Alzheimer trial UCB's bepranemab slowed the accumulation of tau in the brain but did not slow disease progression in its first phase II test in Alzheimer disease (AD).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04867616

NCT04867616 | A Study to Test the Efficacy, Safety, and ... A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD).

5. alzheimer-europe.org alzheimer-europe.org/news/ucb-presents-phase-ii-data-bepranemab-early-ad?language_content_entity=en

UCB presents phase II data on bepranemab in early AD However in key secondary endpoints, bepranemab slowed cognitive decline (ADAS-Cog14) and rate of tau accumulation versus placebo. In a deeper ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04867616

NCT04867616 | A Study to Test the Efficacy, Safety, and ... A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD).

7. ucb.com ucb.com/innovation/clinical-studies/clinical-studies-index/Bepranemab-UCB0107

Bepranemab (UCB0107) Mild Cognitive Impairment or Mild Alzheimer's Disease (AD), A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild ...

8. neurologylive.com neurologylive.com/view/anti-tau-agent-bepranemab-slows-tau-accumulation-phase-2-together-trial

Anti-Tau Agent Bepranemab Slows Tau Accumulation in ... Bepranemab reduced tau accumulation by 33-58% in Alzheimer's patients, showing the first clinical benefit of a tau-directed therapy. Secondary ...