LAURIET

Information about the drug that will be tested in the study

Administration

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

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

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

• A dose of Semorinemab and a dose of [18F]GTP1 (as part of positron emission tomography (PET) imaging) via an intravenous infusion
• An intravenous infusion of placebo (inactive substance identical in appearance to the drug being tested) and a dose of [18F]GTP1.

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

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the efficacy and safety of Semorinemab in people with moderate Alzheimer's disease

How long will the treatment last?

Around 1 year (9 visits)

What your involvement will entail?

• Complete some laboratory tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
• Complete a memory test (MMSE) to assess cognitive function
• Complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
• Complete other tests to evaluate cognitive impairment and functional capacities (i.e. ADAS-Cog, ADCS-ADL).

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

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

• Be 50 to 85 years old
• Have a diagnosis of probable Alzheimer’s disease dementia according to the National Institute on Aging/Alzheimer's Association core clinical criteria
• Have evidence of abnormal accumulation of amyloid in their brain (as per results of CSF examination (spinal tap) or brain scans)
• Have a score between 16 and 21 points in the MMSE test (a test about your memory) and a score or 1 or 2 in the Clinical Dementia Rating-Global Score (CDR-GS). This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
• Have a study partner who has a sufficient contact with the participant, provides the necessary information about the participant’s memory, behaviour and functioning.

Who cannot participate in the study?

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

• A pregnancy or breast-feeding for female participants
• Contraindication to PET imaging and MRI procedures
• Any evidence of a condition other than Alzheimer’s disease that may affect cognition (e.g. other type of dementia, other neurodegenerative disease or infections with neurological involvement)
• History of alcohol or drug abuse within the past two years
• Use of immunotherapy against Aβ or therapy intended to treat Parkinsonian symptoms or any other non-Alzheimer’s disease neurodegenerative disorder within 1 year of screening
• A current daily treatment with opiates, benzodiazepines, neuroleptics, or antiepileptic drugs.

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

Information for your doctor

EudraCT Number

2018-003398-87

Clinicaltrials.gov identifier

NCT03828747

Study contact information

global-roche-genentech-trials@gene.com

Link to full text

https://clinicaltrials.gov/ct2/show/study/NCT03828747

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on February 2020.

This document has been reviewed by the pharmaceutical company running this trial.

This document has been reviewed by a member of the European Working Group of People with Dementia.