GRADUATE 1

Information about the drug that will be tested in the study

Administration

The drug will be administered via a subcutaneous injection (an injection under the skin) every month for the first 9 months and then every 2 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 subcutaneous injection of gantenerumab
• A subcutaneous injection of placebo (a 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.

Information about participating in the trial

What are the researchers trying to find out?

The researchers aim to evaluate the efficacy and safety of gantenerumab in people with early Alzheimer’s disease.

How long will the treatment last?

104 weeks (around 2 years)

What your involvement will entail?

• Participants will have to undergo brain scan (PET) or CSF examination (spinal tap) to see if they have amyloid pathology in their brain
• Complete a test that will assess their memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR). The study partner will also be asked to answer these questions
• During the study, participants will be asked to complete other tests that will assess their memory, language, functioning, behaviour, quality of life and other health-related questionnaires (i.e. tests or scales like MMSE, ADAS-Cog…)
• Participants will have to undergo regular brain scans (MRI) to ensure safety.

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 between 50 and 90 years old

• Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
• Have evidence of abnormal accumulation of amyloid in their brain (as per results of CSF examination (spinal tap) or of PET scan)
• Have an impairment in their memory at screening visit
• Have a score between 22-30 points in the MMSE test (a test about a range of everyday mental skills) and between 0.5 and 1.0 in the Clinical Dementia Rating-Global Score (CDR-GS). This would suggest that the person has an impairment that is still at an early stage
• Meet the clinical criteria for probable Alzheimer’s dementia or prodromal Alzheimer’s disease of the National Institute on Aging/Alzheimer's Association (NIAAA)
• If the person is taking an approved anti-dementia medication (i.e. donepezil, rivastigmine, galantamine or memantine) the dosing regimen must have been stable for at least 3 month prior to the screening visit.

Who cannot participate in the study?

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

• Any evidence of a condition other than Alzheimer’s disease that may affect cognition (e.g. other type of dementia, stroke, brain damage, autoimmune disorders (e.g. multiple sclerosis) or infections with neurological involvement)

• History of evident vascular disease that may affect cognition

• History of major psychiatric illness such as schizophrenia or major depression (if not considered in remission)
• At risk of suicide in the opinion of the investigator
• Contraindication to brain scans (MRI or PET)
• Unstable or clinically significant cardiovascular, kidney or liver disease or uncontrolled hypertension
• Alcohol or drug abuse within the past 2 years

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

2017-001364-38

Clinicaltrials.gov identifier

NCT03444870

Study contact information

global-roche-genentech-trials@gene.com

Link to full text

https://clinicaltrials.gov/ct2/show/study/NCT03444870

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