Lumateperone (ITI-007) is an investigational therapy being developed by Intra-Cellular Therapies to treat agitation in patients with dementia, including that caused by Alzheimer’s disease.

The oral therapy is also being assessed as a possible treatment for schizophrenia and bipolar disease.

How lumateperone works

Alzheimer’s disease, the most common cause of dementia, results from damage to nerve cells in the brain that affect memory and the ability to think and learn. Anxiety and agitation are prevalent behavioral symptoms of the disease, and a source of considerable distress for patients and caregivers.

Lumateperone is a first-in-class molecule designed to selectively and simultaneously act on certain neuronal pathways. It modulates the release, uptake, and transmission of serotonin, dopamine, and glutamate, neurotransmitters or signaling molecules that nerve cells use to communicate. These neurotransmitter pathways are linked to severe mental illness.

Lumateperone in clinical trials

The safety, tolerability, and pharmacokinetics (how the therapy is processed in the body) of lumateperone was first assessed in healthy older volunteers and dementia patients (including those with Alzheimer’s) in a dose-escalation Phase 1/2  trial (NCT02078310). Results, announced by Intra-Cellular in 2014, indicated that the therapy was well-tolerated and safe across a range of low doses, and showed “clinical signals for improved cognition.”

In 2016, Intra-Cellular initiated a multicenter, double-blind, placebo-controlled Phase 3 clinical trial (NCT02817906) to evaluate the efficacy and safety of lumateperone (oral 9 mg dose once daily for four weeks) in about 360 people diagnosed with probable Alzheimer’s disease and with clinically significant symptoms of agitation.

Its primary outcome is treatment efficacy as measured by the Cohen-Mansfield agitation inventory – community version (CMAI-C), a tool that assesses the frequency of agitated behaviors in patients. Secondary outcomes include efficacy measurements using the clinical global impression scale for severity (CGI-S) of illness and other behavioral disturbances associated with dementia. The trial, which is scheduled to end in August 2018, is still recruiting at sites across the U.S. Information is available by clicking on its identification (NCT) number.

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