Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease

Status Completed

Clinical Trial 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.

Clinical Trial Description

The present project is an intervention proof of concept study to test the efficacy of neflamapimod in a population of AD patients at an early stage. To track the impact of this drug in patients, the investigators will use an innovative radiotracer, [18F]DPA-714, as a promising ligand of microglial activation targeting the translocator protein (TSPO), specific of microglial activation. The use of [18F]DPA-714 will allow to monitor the evolution of neuroinflammation in patients as a function of treatment. The main objective will be to compare the level of inflammation using the [18F]DPA-714 in neflamapimod and placebo groups after 12 weeks of treatment. Blood and cerebrospinal fluid (CSF) samples and magnetic resonance imaging (MRI) will also be collected to assess inflammation markers and brain structure respectively in these patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03435861
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Completed
Phase	Phase 2
Start date	October 8, 2018
Completion date	June 30, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04079803` - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients	Phase 2
Completed	`NCT04044495` - Sleep, Rhythms and Risk of Alzheimer's Disease	N/A
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT04520698` - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease	N/A
Active, not recruiting	`NCT04606420` - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease	N/A
Recruiting	`NCT05820919` - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase	N/A
Terminated	`NCT03672474` - REGEnLIFE RGn530 - Feasibility Pilot	N/A
Completed	`NCT03430648` - Is Tau Protein Linked to Mobility Function?
Recruiting	`NCT04949750` - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease	N/A
Recruiting	`NCT05288842` - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting	`NCT05557409` - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation	Phase 3
Recruiting	`NCT04522739` - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease	Phase 4
Completed	`NCT06194552` - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07	Phase 1
Completed	`NCT03239561` - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants	Early Phase 1
Completed	`NCT03184467` - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients	Phase 2
Active, not recruiting	`NCT03676881` - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated	`NCT03487380` - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Recruiting	`NCT05328115` - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease	Phase 1
Completed	`NCT05562583` - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease Patients — VIP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms