Bepranemab for Alzheimer's Disease

Recruiting at 130 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

466 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

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