Launching a First-In-Kind Decentralized Clinical Trial, Testing Non-Drug Interventions for Alzheimer's.

The search for an effective pharmacological (drug based) therapeutic for dementia, particularly those stemming from Alzheimer’s Disease (AD), is ongoing, expensive and, to date, has been fraught with multiple dead ends. Despite this bleak outlook, we have strong evidence to suggest that present day technology can be effectively organized to develop a promising therapy to defeat Alzheimer's Disease.

Watch the video below

New For Gitcoin Beta Round!

Thanks to your contributions in GR15 we have built a hardware / software system demonstrating verifiable neurological effects based on applied stimuli, for which we have successfully attained a non-provisional patent. Using this we have generated preliminary human data showing effective and modifiable neural entrainment in humans. If you can help us in this round we will be able to acquire the equipment we need to build an inexpensive and scalable prototype capable of administering a first-in-kind truly decentralized clinical trial, to have therapies reach everyone as soon as possible.

Project Details

Evidence for Effectiveness

Published scientific evidence strongly supports the development of treatments for Alzheimer's disease that are non-pharmacological in nature. Evidence also suggests that multiple such non-pharmacological interventions (NPIs) can act in concert, thereby increasing the effectiveness of such therapies in delaying and even reversing AD. Despite these positive developments, traditional clinical trials for NPIs have only been done on a relatively small scale and testing for efficacy has been mostly performed at clinical centers using standard paper-based assessment tests. This has been mainly due to the complexity in administering an NPI based treatment in a traditional clinical setting.

We are thankful to our amazing team of advisors for supporting us in this work, including renowned neuroscientist Dr. Heather Berlin, and renowned biologists Drs. George Church and Brian Kennedy.

Watch the video below

The PIA MindSet

We are developing a therapeutic device, the PIA MindSet, that incorporates multiple NPI interventions that are safe and have shown promise in both animal testing and in human clinical trials. This headset could be directly marketed and sold to users, where they themselves would directly participate in operating the device and submitting data for analysis. This would circumvent the slow and costly route towards usage and testing that would normally occur through an FDA approved clinical trial setting. Furthermore, the device may also be used by healthy users as a potential means towards cognitive enhancement.

IRENA: an Individually Recorded, Enhanced Neurological Assessment software suite

In conjunction, we propose developing an online individually recorded, enhanced neurological assessment testing tool, IRENA, where individual user parameters, arising from headset usage, along with online cognitive assessments, will be uploaded and analyzed in real time by the user base. This would vastly enhance our ability to assess and improve the therapeutic value of the PIA MindSet. IRENA would give us the capability to 1) gauge efficacy on a vastly larger scale of participants than traditional paper-based assessment tests have done thus far 2) rapidly assess the efficacy of various parameters of the PIA MindSet in real-time and 3) more precisely identify which users are receiving the most therapeutic benefits, i.e. those suffering from mild cognitive impairment (MCI) versus more extreme forms of dementia.

Project Development

To launch the development of the PIA MindSet and IRENA software, we need to establish an initial team of dedicated, full time software developers, hardware prototype fabricators, along with a team lead that would direct all areas of operation. To these ends, it may be useful to break down the Project into three main working groups: Interventions, Assessment and Analytics. Each will require their own particular skill sets to achieve a minimal viable product success for the overall Project. There will be considerable overlap with each working group of course, for example, validating primary scientific literature regarding assessment tests and interventions. The Interventions group would focus on designing and building a device that incorporates several interventions. Also developing the protocols for self-administering the interventions. Manufacturing and distribution will also be a key component of this working group.

The Assessment group would focus on software for the cognitive test. This will require assessing scientific literature and either using and adopting available cognitive tests, such as MiniCog, and/or developing news test that would function on either an iOS/Android smartphone, tablet and/or computer workstation. Another key goal of the assessments group is to have protocols in place that would mimic a trial study with controls and experimental groups that would be the best fit for this type of self administered device. Development of the “trial protocol” itself may involve considerable overlap with members' expertise among all three working groups.

The Analytics group will need to determine the best way to securely store and manage the data arriving from the self-assessment test (IRENA) and determine the best analytical tools to apply to tease out positive outcomes. This will help determine not only which multi-intervention combinations are effective, but also enable us to determine the minimal numbers of participants required to revisit any promising intervention for any future follow-up studies in a more traditional “gold standard” double-blinded clinical trial. If this approach works, it would have the profound effect of upending how standard clinical trials are designed in the future.

How Your Support Will Help Us Fight Alzheimer’s Disease

Your contributions will allow us to bring on additional team members and hasten the completion of our prototype, and — if it is successful — also help us make the resulting therapeutic hardware and software as affordable and easy to use as possible. Doing so will allow it to be maximally available to the public, and tee-up the ability to perform a first-in-kind decentralized clinical trial proving remediation of Alzhiemer’s.

Such an outcome would be incredible not only for the patients themselves, but also for their loved ones and all of society, due to mitigating the vast socio-economic harm caused by such diseases.

Furthermore, finally showing real progress against these diseases will go a long way towards convincing the public that we are at last in the game in terms of fighting age-related diseases generally, and help usher in a new age of support for healthy human longevity. Together we can do this.

Thank You!