Cognitive Neuroengineering Development
PROGRAM

R&D Program

Preclinical studies


In vitro experiments:  Demonstrate the treatment’s neuron-level mechanism of action by modifying neuron excitability and activity with CRISPR.  Time frame:  2021-2022

 

In vivo experiments:  Establish the treatment’s efficacy in mammals by using behavioral and cognitive ability tests in laboratory animals receiving the gene therapy.  Time frame:  2021-2022

Clinical trials

Phase 1 Safety:  Determine safety and dosage in 20-50 healthy adult volunteers for an RNA version of the therapy with temporary effects.  Monitor subjects to learn more about how the therapy works in the body and the effects associated with increased dosage.  Gain early information about efficacy and how best to administer the treatment to limit risks and maximize benefits.  Time frame:  2023


Phase 2 Efficacy: Measure the RNA therapy’s efficacy in relieving cognitive impairment symptoms in a group of several hundred patients in the early and moderate stages.  Closely monitor subjects to identify any side effects.  Time frame:  2024


Phase 3 Efficacy and adverse reactions:  Measure the RNA therapy’s efficacy in relieving cognitive impairment symptoms in a group of 300 to 3000 patients in the early and moderate stages.  Closely monitor subjects to identify any side effects.  Time frame:  2025

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