{"type": "project", "title": "Stopping Alzheimer's with Light and Sound", "logoImg": "bafkreih3arbfspi2ww7up444kjrwgyowwlvaxtaw536f4ooqm6iaseheyq", "website": "https://www.lifespan.io/the-mindset-project/", "bannerImg": "bafkreiakpfgvcuwyq5addbdhe6wokw53a2sa425spsdsisvmtlnspvdcdq", "createdAt": 1682058048056, "userGithub": "KeithComito", "credentials": {"twitter": {"type": ["VerifiableCredential"], "proof": {"jws": "eyJhbGciOiJFZERTQSIsImNyaXQiOlsiYjY0Il0sImI2NCI6ZmFsc2V9..hyvwuTXoZ7XwGYP-_jRLU4IFvuQIdsl7eaToaM19Ci_4yXwHq479INuRTN_NgL9KWAAJfdRJoS_KFwaT0BN1Cg", "type": "Ed25519Signature2018", "created": "2023-04-21T06:13:19.341Z", "proofPurpose": "assertionMethod", "verificationMethod": "did:key:z6MkghvGHLobLEdj1bgRLhS4LPGJAvbMA1tn2zcRyqmYU5LC#z6MkghvGHLobLEdj1bgRLhS4LPGJAvbMA1tn2zcRyqmYU5LC"}, "issuer": "did:key:z6MkghvGHLobLEdj1bgRLhS4LPGJAvbMA1tn2zcRyqmYU5LC", "@context": ["https://www.w3.org/2018/credentials/v1"], "issuanceDate": "2023-04-21T06:13:19.341Z", "expirationDate": "2023-07-20T06:13:19.341Z", "credentialSubject": {"id": "did:pkh:eip155:1:0xa51E0a99B53d5B00937a2631d5865468A3543B7d", "hash": "v0.0.0:AXoiDvrIN28ntOb9HJVbq0wXvyHAZtkzY2eiL3E/6t0=", "@context": [{"hash": "https://schema.org/Text", "provider": "https://schema.org/Text"}], "provider": "ClearTextTwitter#LifespanIO"}}}, "description": "## Launching a First-In-Kind Decentralized Clinical Trial, Testing Non-Drug Interventions for Alzheimer's.\n\nThe search for an effective **pharmacological (drug based) therapeutic for dementia**, particularly those stemming from **Alzheimer\u2019s 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.**\n  \n**[Watch the video below](https://vimeo.com/750458841/779478118e)**\n**[![IMAGE ALT TEXT](https://i.vimeocdn.com/video/1508827312-3ae4178ba675e6410f6aba969e0e45b3c83d863c5734d0d64068e05093373704-d?mw=1280&mh=720&q=70)](https://vimeo.com/750458841/779478118e \"MindSet Project Description Video\")**\n\n***New For Gitcoin Beta Round!***\n\nThanks 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](https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/11612757?fbclid=IwAR0DsCUzpGIC6jljPKItCfeQNJCEPCuJSddVTAaFPK2xfCisY1LP1_piUiY)**. 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.\n\n![Dr. Oliver Medvedik administers visual and audio stimuli to himself and his mother, Irena](https://c.gitcoin.co/docs/2f2f39c5b519d74095647cba7ac82d75/MindSet-Love.jpg)\n\n## Project Details\n\n***Evidence for Effectiveness***\n\nPublished 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.\n\nWe 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**.\n\n**[Watch the video below](https://youtu.be/Pn_J-f1-8dg)**\n**[![IMAGE ALT TEXT](https://img.youtube.com/vi/Pn_J-f1-8dg/maxresdefault.jpg)](https://youtu.be/Pn_J-f1-8dg \"Can Music Fight a Real Life Vecna? Stranger Things Running Up That Hill Explained - Science Blast\")**\n\n***The PIA MindSet***\n\nWe 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 c**ould 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**.\n  \n***IRENA: an Individually Recorded, Enhanced Neurological Assessment software suite***\n\nIn 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.\n\n![MindSet Project Components Diagram](https://c.gitcoin.co/docs/400c161dbe0e5bfae83fd2500b4ae154/MindSet-Diagram.jpg)\n\n***Project Development***\n\nTo 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**.\n\nThe **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 \u201ctrial protocol\u201d itself may involve considerable overlap with members' expertise among all three working groups. \n\nThe **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 **\u201cgold standard\u201d** 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.\n\n***How Your Support Will Help Us Fight Alzheimer\u2019s Disease***\n  \n**Your contributions** will allow us to bring on additional **team members** and hasten the **completion of our prototype**, and \u2014 if it is successful \u2014 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\u2019s**.\n\n  \n\nSuch 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.\n\nFurthermore, **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.\n\n### Thank You!", "logoImgData": {}, "bannerImgData": {}, "projectTwitter": "LifespanIO"}
Stopping Alzheimer's with Light and Sound
## 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](https://vimeo.com/750458841/779478118e)**
**[![IMAGE ALT TEXT](https://i.vimeocdn.com/video/1508827312-3ae4178ba675e6410f6aba969e0e45b3c83d863c5734d0d64068e05093373704-d?mw=1280&mh=720&q=70)](https://vimeo.com/750458841/779478118e "MindSet Project Description Video")**

***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](https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/11612757?fbclid=IwAR0DsCUzpGIC6jljPKItCfeQNJCEPCuJSddVTAaFPK2xfCisY1LP1_piUiY)**. 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.

![Dr. Oliver Medvedik administers visual and audio stimuli to himself and his mother, Irena](https://c.gitcoin.co/docs/2f2f39c5b519d74095647cba7ac82d75/MindSet-Love.jpg)

## 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](https://youtu.be/Pn_J-f1-8dg)**
**[![IMAGE ALT TEXT](https://img.youtube.com/vi/Pn_J-f1-8dg/maxresdefault.jpg)](https://youtu.be/Pn_J-f1-8dg "Can Music Fight a Real Life Vecna? Stranger Things Running Up That Hill Explained - Science Blast")**

***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 c**ould 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.

![MindSet Project Components Diagram](https://c.gitcoin.co/docs/400c161dbe0e5bfae83fd2500b4ae154/MindSet-Diagram.jpg)

***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!
Stopping Alzheimer's with Light and Sound