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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2025
  • participants needed
    450
  • sponsor
    UCB Biopharma SRL
Updated on 22 September 2022
Investigator
UCB Cares
Primary Contact
Ah0003 50448 (4.5 mi away) Contact
+85 other location
cognitive impairment
positron emission tomography
dementia
mini-mental state examination
alzheimer's disease
mild cognitive impairment
amyloid
mental state examination
cognitive assessment

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).

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).

Details
Condition Alzheimer's Disease
Treatment Placebo, Bepranemab
Clinical Study IdentifierNCT04867616
SponsorUCB Biopharma SRL
Last Modified on22 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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