CLINICAL TRIALS WATCH

Transcription

1 CLINICAL TRIALS WATCH DEMENTIA-FRIENDLY INFORMATION ON: JNJ STUDY

2 JNJ in participants who are at risk for developing Alzheimer's dementia 1. Study Information Name of the study Study sponsor Disease An efficacy and safety study of JNJ in participants who are asymptomatic at risk for developing Alzheimer's dementia Janssen Alzheimer s disease, more specifically people at higher risk to develop Alzheimer s dementia 2. Information about the drug that will be tested in the study Name of drug Administration Is the drug already on the market for another medical condition? Will all participants receive the same drug? JNJ A tablet taken once daily No Participants will be selected by chance to receive one of the following options: One tablet of 5mg of JNJ One tablet of 25mg of JNJ One placebo tablet (a dummy treatment) Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo. 3. Information about participating in the trial What are the researchers trying to find out? The purpose of this study is to evaluate the safety and efficacy of treatment with JNJ to slow cognitive decline in participants who are at risk of developing Alzheimer's dementia

3 (i.e. people who have abnormal deposits of a protein called amyloid in the brain, but who have no symptoms of dementia). How long will the treatment last? Participants will be asked to take the drug 4 and a half years. After this, they will be monitored for 1 to 4 weeks. Participants' safety will be monitored throughout the study. Participants completing the study (including those taking the placebo) will be offered the opportunity to enter into an extension study where all participants will receive JNJ What will your involvement entail? During the study, participants will be asked to complete different tests that will assess changes in their cognition, functioning and in biomarkers (this include results of brain scan or lumbar puncture). Further information on the procedures, tests and number of visits can be obtained from the study team. 4. Who can participate in this study? Who can participate in the study? To take part in the study, participants must: Be 60 to 85 years old. Have no cognitive problems at the screening visit. The score of the Clinical Dementia Rating (CDR) Scale should be '0' (the CDR is a scale used to evaluate the severity or stage of dementia. This scale ranges from 0 to 5, with 0 indicating no dementia and 5 severe dementia). 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. Be healthy for their age or medically stable (with or without medication). This will be determined by the study doctors on the basis of a physical examination, medical history, vital signs and an electrocardiogram (ECG) that will be performed at the screening or at the beginning of the study.

4 Be able to read and write and must have adequate sight and hearing to complete the tests. The study partner must also be able to read and write. In addition, participants who are 60 to 64 years of age must also have one of the following the conditions: a) at least one first-degree relative with dementia b) APOE4 gene (a gene associated with increased risk of Alzheimer s disease) c) Elevated accumulation of amyloid (as per cerebrospinal fluid (CSF, lumbar puncture) or PET (brain scan)). For conditions b and c, the test results should be available prior to the visit. Who cannot participate in the study? People cannot participate if: They have any brain disease or any other abnormality (e.g. folic acid or vitamin B12 deficiency) other than potential very early signs of Alzheimer's disease that could explain a possible cognitive deficit. It is unsafe for the person to have an MRI brain scan due to having prostheses, implants, a pacemaker or claustrophobia. There is evidence of familial autosomal dominant Alzheimer s disease (this is a rare, hereditary form of Alzheimer s disease that is entirely passed down through the family from parents to children). The person meets the criteria for dementia. The person is taking an anti-dementia drug (donepezil, rivastigmine, galantamine or memantine) at the time of the screening visit or at the beginning of the study. The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

5 5. Where and when will the study be conducted? European countries that will be involved in the trial Belgium Denmark France Finland Germany Netherlands Spain Sweden Switzerland United Kingdom Estimated start date of recruitment November 2015 (ongoing) Completion date April Information for your doctor EudraCT Number: Clinicaltrials.gov identifier NCT Study contact information Link to full text =Search The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) The pharmaceutical company running this trial (JANSSEN) has reviewed this document. This document has been reviewed by a member of the European Working Group of People with Dementia.