Study Information

Scientific title

A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal to Mild Alzheimer's Disease

Study sponsor

Genentech / Roche

Disease

Alzheimer’s disease

Phase

Phase II

Information about the drug that will be tested in the study

Name of drug

RO7105705 (also called RG6100)

Administration

An intravenous infusion of RO7105705 once every 4 weeks

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

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

• An intravenous infusion of RO7105705 (dose 1)
• An intravenous infusion of RO7105705 (dose 2)
• An intravenous infusion of RO7105705 (dose 3)
• An intravenous infusion of placebo (an inactive substance identical in appearance to the drug being tested).

Neither the participant nor their 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 RO7105705 in participants with prodromal to mild Alzheimer’s disease.

How long will the treatment last? 

• Around 1 and a half year
• Participants completing the study will be offered the opportunity to enter into an extension study for 96 weeks.

What will your involvement entail?

During the study, participants will be asked to:

• Complete a test that will assess their memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR)
• Complete tests to evaluate possible cognitive impairment (ADAS-Cog, RBANS)
• Complete a questionnaire to evaluate the ability to perform activities of daily living (ADCS-ADL)
• Participants will be asked to undertake brain scans (PET).

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 80 years old
• Have a diagnosis of probable Alzheimer’s disease dementia or prodromal Alzheimer’s disease (according to the National Institute on Aging- Alzheimer’s Association)
• Have results of a lumbar puncture (CSF) or a brain scan (PET) showing that the participant has accumulation of a protein called amyloid in the brain
• Have a score higher than 20 points in the MMSE test (a test about your memory) 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 in their memory that is at a mild stage
• Evidence of abnormal memory function at screening
• Have a study partner who has a sufficient contact with the participant, is willing to accompany the participant to all study visits, and provides the necessary information about the participant’s cognitive and functional ability.

Who cannot participate in the study?

Exclusion criteria include:

• A pregnancy or breast-feeding for female participants
• Have any contraindication to brain scans (MRI or PET scans)  or lumbar puncture (CSF)
• Residence in a nursing facility
• Evidence of a condition other than Alzheimer’s disease that may affect cognition (e.g. other type of dementia, stroke, brain damage, autoimmune disorders or infections with neurological involvement)
• Alcohol or substance abuse in past two years
• Have participated in a recent clinical study (e.g. this exclusion period could be of 3 months duration if people participated into a study with a drug against tau for Alzheimer's disease)
• History of treatment with drugs to treat Parkinson’s symptoms or any other neurodegenerative disorder within the last year.

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

Where and when will the study be conducted?

European countries involved in the trial (active)

• Belgium
• France
• Germany
• Italy
• Netherlands
• Poland
• Spain
• Sweden
• UK

European countries involved in the trial (planned)

• Denmark
• Finland

Estimated start date of recruitment

October 2017

Information for your doctor

EudraCT Number

2017-001800-31

Clinicaltrials.gov identifier

NCT03289143

Study contact information

global-roche-genentech-trials@gene.com

Link to full text

https://clinicaltrials.gov/ct2/show/study/NCT03289143?show_locs=Y#locn

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on January 2019.

The pharmaceutical company running this trial has reviewed this document.

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