Roche Skyline Brain Amyloid Study

Research Study on Preclinical Alzheimer's Disease

About This Study

The purpose of this study is to evaluate the efficacy of gantenerumab, an antibody that binds to and removes deposited amyloid plaque in the brain. Elevated brain amyloid has been associated with an increased risk of developing Alzheimer’s Disease (AD). In previous studies, gantenerumab has been shown to reduce levels of amyloid in the brain, which may prevent or slow the development of symptoms associate with AD, such as cognitive deficits or memory loss.

This is a blinded, randomized, placebo-controlled study, which means you will have a 50/50 chance of receiving the study drug or a placebo. You and the researcher will not know which group you are in until the study enters the open-label phase.

The study is expected to take approximately 4-5 years and is comprised of the following parts:

(1)   Screening period (up to 17 weeks long)

This phase includes cognitive assessments, bloodwork, and a PET scan. The result of these tests will determine whether you are eligible to participate in this study. If these tests show that you do not have sufficiently elevated levels of amyloid in your brain, you will not be able to participate in the study.

(2)   Study treatment period (4-5 years long)

If you qualify and choose to take part in the study, you will be randomly assigned to a study treatment group. You will have a 50/50 chance of receiving the study drug or a placebo. While you are receiving the study treatment, you will be asked to come to the clinic approximately every 6 months, with each visit lasting between 1-5 hours. During these clinic visits, a trained clinician will administer injections under the skin of your abdomen.

(3)   Safety follow-up period

You will be asked to return to the study site for a final safety visit 16 weeks after the end of the study treatment period. This visit includes a review of your medical history, in addition to a few questionaries, a physical examination, and imaging.

You may qualify for this study if you…

· Are between the ages of 60-80 years old.

· Are cognitively unimpaired and not currently experiencing any memory or thought-processing deficits.

· Do not currently have a diagnosis of mild cognitive impairment (MCI), Alzheimer’s disease (AD), or dementia.

· Have elevated levels of amyloid protein in the brain based on PET scan results.

· Are willing to make yourself available to participate in virtual and in-person procedures for the duration of the study.

· Have a reliable study partner who is frequent contact with you.

The study partner will provide emotional and practical support throughout the duration of the study.