NeuroNEXT, a NINDS initiative to conduct Phase 2 trials in neurological conditions, receives proposals from academics, foundations and industry. All proposals are evaluated for mission relevance and institute priority by NINDS and for network feasibility by the NeuroNEXT Executive Committee (NEC). All proposals which are found to be mission relevant, feasible and of sufficient institute priority are referred to protocol working groups (PWG) for development of grant applications. The NINDS, NEC and PWG do not make any determination as to scientific merit; applicants should be aware that the fact that NeuroNEXT is submitting a proposal for review is no guarantee of funding approval. The scientific review of the proposal occurs after the grant application has been submitted for peer- and council-review. Funding decisions are made based on the results of those reviews.

Future Projects FOAs
(PAR-11-343 || PAR-11-344 || PAR-11-345 )

Would this be a possible funding mechanism for trials carried out in adult neurocritical care units for diseases such as subarachnoid hemorrhage, intracranial hemorrhage, status epilepticus, specific ICU management of patients, etc.?
Future research projects to be conducted by the network can be in any neurological disease or patient population burdened by neurological disease depending on available funding and scientific opportunity.
Will there be any interactions with the PD biomarker effort?
These are separate initiatives. However, the network can support any NINDS-funded clinical research program at the site, when there is capacity. For example, when there are few network-specific activities at a given time at the site, the network coordinator can support other NINDS-funded studies, including work related to PD biomarkers. The network also can carry out biomarker validation studies in diseases other than PD, if these projects are successful in peer review and funding.
How do you anticipate integrating imaging centers/projects?
Imaging projects may be part of biomarker validation studies, or part of phase 2 trials that use imaging biomarkers. Imaging centers will be included as needed as part of project specific proposals.
Will future research projects provide funding for basic/translational research as well as clinical trials?
The future funding is for clinical research projects only. NINDS has several funding mechanisms for basic and translation research that are independent of this network. However, translational researchers with an IND may consider interacting with network PIs as they plan the implementation of phase 2 trials.
Will disease that fall under the domain of NINDS as well as other ICs, such as autism or sleep, be eligible for clinical trials? How will these trials interface with other ICs?
The network is primarily intended for neurological diseases that typically fall under the domain of the NINDS. Should scientific opportunities arise in neurological diseases that typically fall under the domain of institutes other than the NINDS, our program staff will consider the appropriateness for the use of network capacity.
Do non-Alzheimer's dementias fall under the purview of NINDS? For example, fronto-temporal dementia, Lewy body dementia, NPH?
Yes.
Will psychiatric trials be included?
No, psychiatric diseases are not included.
Is there going to be an accelerated review path for funding projects that appear high priority for this network?
Yes, we anticipate an accelerated review path.
How do you envision prioritizing concepts for access to this network?
This will depend on scientific opportunity, likelihood that the project is feasible and has potential to result in a better treatment for patients, path forward in terms of Phase 3 trial plans, institute priorities and availability of funds.

FAQS