Dementia is one of the most persistent and devastating disorders of old age because it eventually leads to a complete loss of memory and of the ability to function independently. It is estimated that over five million people in the United States have Alzheimer’s disease (AD) and/or another related dementia (ADRD), with an estimated cost to society of over $200 billion per year. Because of the aging populations worldwide, the number of individuals with dementia will reach epidemic proportions even in the best-case scenarios, with an enormous human and economic burden. It is projected that 11 to 16 million people and their families could be affected by dementia by the middle of this century if no effective therapies are developed to prevent, slow or stop it.
Currently there are only a few interventions that have been approved by the Food and Drug Administration for treatment of AD, and those approved have demonstrated only modest effects in modifying the clinical symptoms for relatively short periods. None has shown a clear therapeutic effect on disease progression. There have been no FDA-approved interventions for ADRD. The Alzheimer’s Association’s 2015 trajectory report estimates that a treatment delaying onset of symptoms by five years and beginning to show its effect in 2025 would decrease the total number of older Americans with dementia from 8.2 million to 5.8 million in 2030. Moreover, a treatment that even slowed disease progression would result in far fewer people with AD in the severe stage that requires the highest level of care with the greatest costs.
While there have been no newly approved treatments for AD since 2003, there are multiple therapeutics currently in development at various stages. In particular, there are a number of therapies focused on prevention, and those trials require screening of thousands of participants to identify eligible individuals. Reliable and efficient trials infrastructure is needed to meet this trial demand. Clinical trial networks can increase the efficiency of research by providing infrastructure, centralized resources, and access to well-characterized participants. The Alzheimer’s Clinical Trials Consortium (ACTC) was developed to meet this need.
Utilizing the ACTC, the goal of this FOA is to invite research grant applications that provide clinical testing (Phases I-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.
Clinical trials funded from this FOA will be implemented through ACTC. The clinical trials approved for funding will develop their final protocols in conjunction with the ACTC. All of the 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.
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 Steering Committee in order to discuss the feasibility of conducting the proposed trial through the ACTC infrastructure before submitting an application.
Deadlines: standard dates apply
Filed Under: Funding Opportunities