Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease Patients
Status:
Recruiting
Trial end date:
2021-06-30
Target enrollment:
Participant gender:
Summary
For this project, neflamapimod and placebo will be provided free of charge by the EIP company
(www.eippharma.com). Neflamapimod is currently tested in 2 clinical trials in AD, one in
Europe (The Netherlands) and one in the USA (clinical trials.gov/VX-745). The company
commenced in May 2015 dosing in two phase 2a clinical studies in patients with Early AD: one
in the Netherlands that is focused on PET amyloid imaging as the primary biomarker of drug
effect, and one in the US (California) that is focused on Cerebrospinal fluid (CSF)
evaluation to determine CSF drug concentrations and effects on inflammatory markers and
disease biomarkers. Pharmacokinetic evaluation in these patients has demonstrated blood drug
concentration levels in the predicted therapeutic range; and importantly, the data from the
US study demonstrate that the drug achieves target drug concentrations in CSF, thus
confirming the drug robustly enters the brain in humans.
The present project offers us a unique chance to test this promising drug in AD patients. The
aim of the study is to focus on PET neuroinflammation imaging as the primary biomarker of
this drug effect. The chosen biomarker for imaging neuroinflammation in patients is [1
8F]-DPA714.