TOGETHER

A study to test the efficacy, safety, and tolerability of bepranemab in patients with mild cognitive impairment or mild Alzheimer's disease

Conditions

Sponsor

UCB Biopharma SRL

Phase

Status

Drug

Bepranemab (also called UCB0107)

Countries

Belgium, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

The drug will be administered via an intravenous infusion (an injection into the vein) every four weeks.

Participants will be selected at random to either receive one of the following options:

An intravenous infusion of Bepranemab (Dose 1 or 2)
An intravenous infusion of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

The purpose of this study is to evaluate the safety, tolerability and efficacy of Bepranemab in people with prodromal to mild Alzheimer's disease.

80 weeks (around 1.5 years)
After the 80-week period, study participants will be eligible to enter a 48-week open-label extension period with planned treatments of Bepranemab.

During the study, participants will be asked to complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
To complete other tests that will assess their memory, suicidal behaviour, functioning, cognition improvement and activities of daily living (i.e. tests like ADAS-Cog, MMSE, C-SSRS)
To complete some laboratory/biological tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
Participants will be asked to undertake brain scans (PET) to see changes in biomarkers in the brain

Further information on the procedures, tests and number of visits can be obtained from the study team.

To take part in the study, participants must:

Be between 50 and 80 years old
Have a diagnosis of prodromal/mild cognitive impairment due to Alzheimer's disease or a diagnosis of mild Alzheimer's disease according to the National Institute on Aging/Alzheimer's Association core clinical criteria
Have a score of 0.5 to 1 in the Clinical Dementia Rating-Global Score (CDR) and a score of above 20 in the MMSE test questionnaire test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild stage
Have evidence of abnormal accumulation of amyloid in the brain (determined either through CSF examination (lumbar puncture) or with the use of an amyloid PET scan)
Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration (at least 5 hours a week).

People cannot take part in the study if they have or have experienced:

Any evidence of a condition that may affect cognition other than Alzheimer’s disease
Contraindication to PET imaging and MRI procedures)
A disease or conditions that may interfere with the safety, tolerability and/or study assessments, or put the participant at special risk (e.g. psychiatric symptoms, auto-immune disease, inflammatory neurological disorders)
Any alcohol or drug abuse within the past two years
Participation in another clinical study within the past six months
Previous treatment with medication intended to treat a neurodegenerative disorder (other than Alzheimer’s disease) within the past year
Treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates or hypnotics.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.