MIcroglial CSF1R in AD - MICAD
Research type
Research Study
Full title
A randomised, placebo-controlled, single-blind study to characterise the biomarker effects of the CSF-1 receptor antagonist JNJ-40346527 in participants with mild cognitive impairment
IRAS ID
252573
Contact name
N.A CTRG
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Eudract number
2018-004149-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
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.
We would like to look at 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. We want to see how well JNJ-40346527 is able to block CSF-1R, and in turn suppress these microglial cells.
This 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 may provide us with useful “biomarkers”, measures of change in the body, which we 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.
This present study is not designed to test whether or not this drug can slow the progression of Alzheimer’s disease.
If we find good biomarkers from this study, we will be able to later design studies to test whether JNJ-40346527 can slow or prevent the progression of Alzheimer’s disease.
Lay summary of study results: MICAD had been delayed due to the COVID19 pandemic, and was difficult to resume once research sites could be opened. The study drug was due to expire before it could be used for this study. The funder was unwilling to provide additional drug to continue the study. The study closed after only 2 participants were recruited. One participant completed the study, one dropped out partway through.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/0904
Date of REC Opinion
7 Jun 2019
REC opinion
Favourable Opinion