MIcroglial Colony Stimulating Factor-1 Receptor (CSF1R) in Alzheimer's Disease (MICAD)
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|ClinicalTrials.gov Identifier: NCT04121208|
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Mild Cognitive Impairment||Drug: JNJ-40346527 Other: Placebo||Phase 1|
Alzheimer's disease (AD) is a slow, progressive disease that profoundly affects memory and everyday function. There are treatments available that can help manage symptoms, but at present there is no cure, and no treatment that is effective at slowing the progression of AD. AD can begin to cause brain damage decades before symptoms such as memory loss become apparent.
The trial will investigate the effect of the drug JNJ-40346527 on CSF-1R (colony stimulating factor-1 receptor), which is a protein on the outside of cells present in the brain. CSF-1R is responsible for the regulation of various cells, including microglial cells. Recent research suggests that reducing numbers of these microglial cells may be beneficial in slowing the progression of Alzheimer's disease. The Investigators want to see how well JNJ-40346527 is able to block CSF-1R, and in turn suppress these microglial cells. The study is designed to investigate whether or not it is possible to identify changes in levels of proteins which interact with CSF-1R, and changes in the activity or number of affected microglial cells present in the brain. This evidence may provide useful "biomarkers", measures of change in the body, which the Investigators could track to see how the drug is working. These "biomarkers" could then be used in further larger studies to more thoroughly test the benefits of the drug JNJ-40346527. The present study is not designed to test whether or not this drug can slow the progression of Alzheimer's disease.
If biomarkers are identified in the study, further studies will be designed to test whether JNJ-40346527 can slow or prevent the progression of Alzheimer's disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase 1b, randomised, single-blind, placebo-controlled parallel-group trial with JNJ-40346527 in adults with Mild Cognitive Impairment (MCI)|
|Masking Description:||Single-blind with participants blinded to treatment.|
|Official Title:||A Randomised, Placebo-controlled, Single-blind Study to Characterise the Biomarker Effects of the Colony Stimulating Factor-1 (CSF-1) Receptor Antagonist JNJ-40346527 in Participants With Mild Cognitive Impairment|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
Active Comparator: Active drug: JNJ-40346527
A single initial randomisation site will be set up for Part 1 that will assign participants to JNJ-40346527 300 mg Bis in die - twice a day (BID) or placebo in a 2:1 ratio.
A second randomisation site will be setup for Part 2 depending on which scenario is adopted.
Either a "Part 2, Scenario 1" site will assign participants to JNJ-40346527 150 mg BID, JNJ-40346527 50 mg BID or placebo in a 2:2:1 ratio or a "Part 2, Scenario 2" site will assign participants to JNJ-40346527 150-50 mg BID or placebo in a 2:1 ratio.
Active study drug
Placebo Comparator: Placebo
Non-active study drug
Non-active study drug
- Placebo-controlled change from baseline in cerebrospinal fluid (CSF) protein marker concentration levels. [ Time Frame: Baseline and visit 5 (Days 15 to 18) ]Change from baseline in concentration levels of CSF fluid protein markers including but not limited to interleukin (IL)-34 and CSF-1.
- Placebo-controlled change from baseline in CSF and blood biomarker concentration levels [ Time Frame: Baseline and visit 5 (Days 15 to 18) ]
- Placebo-controlled change from baseline in amount of CSF extracellular vesicles and cell population. [ Time Frame: Baseline and visit 5 (Days 15 to 18) ]
- Measurement of plasma/CSF JNJ-40346527 levels [ Time Frame: Baseline and visit 5 (Days 15 to 18) ]
- Measurement of cerebrospinal fluid (CSF) protein marker concentration levels following different JNJ-40346527 doses [ Time Frame: Baseline and visit 5 (Days 15 to 18) ]
- Occurrence of adverse events during the study [ Time Frame: Baseline and visit 5 (Days 15 to 18). Serious Adverse Events (Day 15-18 plus 30 days) ]Safety and tolerability will be assessed by monitoring adverse events identified using key safety assessments: physical and neurological examinations, vital sign measurements, clinical laboratory tests and 12-lead ECGs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121208
|Contact: Vanessa Raymont||01865 ext email@example.com|
|Cambridgeshire and Peterborough NHS Foundation Trust|
|Cambridge, United Kingdom|
|Principal Investigator: Dennis Chan|
|South London and Maudsley Hospital NHS Foundation Trust|
|London, United Kingdom|
|Principal Investigator: Dag Aarsland|
|Oxford Health NHS Trust|
|Oxford, United Kingdom|
|Principal Investigator: Vanessa Raymont|
|Principal Investigator:||Vanessa Raymont||University of Oxford|