Bepranemab for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+130 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UCB Biopharma SRL

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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.

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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.

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Treatment Details

Interventions

Bepranemab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.