Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required)

This Funding Opportunity Announcement (FOA) invites applications to develop and implement Phase Ib to III clinical trials of promising pharmacological and non-pharmacological interventions that may prevent, delay, or treat the symptoms of Alzheimer's disease (AD) and other age-related dementias using the Alzheimer's disease Clinical Trials Consortium (ACTC) trial coordination and management infrastructure.Research Objectives Utilizing the ACTC, the goal of this FOA is to invite research grant applications that provide clinical testing (Phases Ib-III) of promising pharmacological and/or non-pharmacological interventions for cognitive and neuropsychiatric symptoms in individuals with AD or other aging-related dementias across the spectrum from pre-symptomatic to more severe stages of disease. Working with the ACTC is a cooperative venture between the applicant, the NIA, and the ACTC network. NIA and the ACTC leadership will provide guidance to potential applicants. Potential applicants are strongly encouraged to contact NIA Scientific/Research Contacts (see Agency Contacts, Section VII) and the ACTC study team in order to discuss the feasibility of conducting the proposed trial through the ACTC infrastructure before considering an application. The ACTC infrastructure is welcoming of the following: Academic and industry applicants Pharmacological and non-pharmacological interventions Applications are encouraged that propose the following: Testing candidate therapeutic compounds against novel therapeutic targets Testing repurposed drugs derived from data-driven approaches, including candidates coming from NIA's translational bioinformatics FOA (PAR-17-032) Logistical guidance: Potential applicants undergo initial vetting of proposed study by the ACTC protocol evaluation committee and final review by the steering committee. Applicants should contact the ACTC study team at least 5 months prior to their desired NIA submission cycle. Contact details and more information may be found at actcinfo.org. Applications should anticipate using a centralized IRB. Applicants should be aware of the data and resource sharing requirements. The use of common contract language is strongly encouraged. Note, the ACTC infrastructure is not appropriate for: Single site clinical trials Routine Phase Ia first-in-human Clinical trials funded from this FOA will be implemented through the ACTC. The clinical trials approved for funding will develop their final protocols in conjunction with the ACTC. All ACTC sites will have the option to request participation and will be selected based on their capabilities specific to the individual protocols. Investigators are strongly encouraged to collect blood and other biosamples for future genomic and other 'omic' analyses aimed at interrogating treatment responsiveness and examining predictors of decline and progression. See Section VIII. Other Information for award authorities and regulations.