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

Last updated: April 5, 2022
Sponsor: UCB Biopharma SRL
Overall Status: Active - Recruiting

Phase

2

Condition

Alzheimer's Disease

Treatment

Placebo

Bepranemab

Clinical Study ID

NCT04867616
2020-005829-88
  • Ages 50-80
  • All Genders

Study Summary

Welcome to Together __ __

A study for memory loss __ __

If you are concerned about changes to your memory, joining the Together clinical study might be a suitable option for you. __ __

To qualify for this study, you must: __ __

__· __Be between 50 and 80 years old __ __

__· __Have mild memory problems or early Alzheimer’s disease __ __

__· __Meet some additional study criteria __ __

The medications are provided at no cost and your reasonable expenses for attending study visits will be reimbursed.

Together is a Phase 2 study. This is the first time people with memory problems are taking this drug. There have already been 2 studies in healthy people and there are ongoing studies with the same drug for a different disease. The results from Together will decide whether the study drug is suitable for Phase 3 studies for this condition.

About the Together Study __ __

The Together Study is researching whether an investigational medication might be able to slow down the development of memory problems in people who already have some memory loss. __ __

All the people who decide to join the Together Study will at some point receive the investigational medication (called bepranemab). __ __

During the Together Study, doctors will carry out regular checks on participants’ health and memory. These checks will take place at the doctor’s office. __ __

As part of the study, participants will take part in various exercises that measure how their brains respond to new information. This is called ‘cognitive testing’ and is used to help doctors work out what kind of memory loss a person has. __ __

Information from these regular checks will tell us how the investigational medication is affecting people’s bodies and minds.

If people visit the website - https://www.together-memory.com they can take a test and be referred to a study site near to them (if available).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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)
  • A global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDR-Memory Box (CDRMB) score ≥0.5 at Screening and Baseline
  • Score of ≤85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening
  • Mini-Mental State Examination (MMSE) score ≥20 at Screening
  • Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care
  • 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
  • Evidence of cerebral Aβ accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratio assessment

Exclusion

Exclusion Criteria:

  • Any evidence of a condition that may affect cognition other than AD
  • Contraindications to PET imaging
  • Inability to tolerate or contraindication to magnetic resonance imaging
  • Any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation
  • Alcohol or drug abuse within 2 years of screening
  • 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
  • Chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic activitiy
  • Received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 09, 2021
Estimated Completion Date:
November 30, 2025

Study Description

The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).

Connect with a study center

  • Ah0003 50422

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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