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This Phase I clinical trial will test the safety of NTRX-07, an experimental drug designed to reduce brain inflammation in Alzheimer’s disease
Joseph Foss, M.D.
NeuroTherapia, Inc.
Cleveland, OH - United States
Background
In addition to the accumulation of amyloid plaques and tau tangles, inflammation in the brain is becoming increasingly recognized as a key factor in Alzheimer’s disease. During Alzheimer’s disease, immune cells in the brain known as microglia can become activated and release substances that promote brain inflammation and may lead to nerve cell damage. Novel treatments that target brain inflammation could potentially help to slow or prevent Alzheimer’s disease.
NTRX-07 is an experimental drug that has been shown to reduce brain inflammation and improve cognitive function in Alzheimer’s-like mice. NTRX-07 binds to a receptor or “docking site” on the surface of microglia known as the cannabinoid type 2 (CB2) receptor. NTRX-07 is believed to reduce the activation of microglia, and thereby reduce inflammation in the brain.
Research Plan
Joseph Foss, M.D., and colleagues have proposed the first test of NTRX-07 in humans to determine what doses are safe and how the drug is absorbed and eliminated by the body (pharmacokinetics). Participants in the Phase I clinical study will be healthy volunteers, who will each receive a single dose of the drug. The investigators will gradually increase the dose given to successive volunteers to determine a safe and optimal dosing regimen. The participants will be closely monitored to determine if there are any negative side effects to the treatment.
Impact
This study is an essential first step to determine if the novel drug NTRX-07 is safe in humans. If successful, future clinical trials will test the drug’s safety in larger groups of participants and determine if it is effective in reducing Alzheimer’s symptoms. The results of this work could lead to the development of NTRX-07 as a potential therapy to reduce brain inflammation and help slow or halt Alzheimer’s disease.
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