IRB Documentation | NCT07214974

Notice: Website recruitment materials and the pre-screening interest form are submitted for Institutional Review Board (IRB) review. Until IRB approval is granted and posted here, public recruitment advertising should not represent these materials as IRB-approved. This page is provided for transparency and does not constitute legal or regulatory advice.

1. Study Identification

NCT Identifier

NCT07214974

Brief Title

MCI Community Screening & Early Intervention

Phase

Early Phase 1

Sponsor

Noah Tech, Corp.

Registry Status

Not Yet Recruiting

IRB Submission Status

Pending

Full study details are available on ClinicalTrials.gov and on our Clinical Trial Information page.

2. IRB of Record

The following IRB information will be published upon confirmation and approval. Fields marked “TBD” are pending final designation by Regulatory Affairs.

IRB Name	TBD — Institutional Review Board of record
IRB Address	TBD
IRB Phone	TBD
IRB Email	TBD
IRB Chair / Contact	TBD
Federalwide Assurance (FWA)	TBD
IRB Registration Number	TBD

3. Submission Status

Submission	Document ID	Submitted	Status	Notes
Website Recruitment Package	WEB-REC-001 v1.0	Pending	Pending	Includes trial.html, homepage trial sections, and related disclosures
Pre-Screening Interest Form	WEB-PRESCREEN-001 v1.0	Pending	Pending	IntakeForm.html — contact authorization only; not informed consent
Informed Consent Form (ICF)	ICF-001	Pending	Pending	Separate from website pre-screening; required before enrollment
HIPAA Authorization	HIPAA-AUTH-001	Pending	Pending	Required for collection of protected health information at enrollment

4. Materials Under IRB Review

The following publicly accessible pages and assets are included in or referenced by the website recruitment submission package:

Material	URL / Location	Purpose	Version
Clinical Trial Information Page	trial.html	Registry-aligned study description, eligibility summary, disclosures	WEB-REC-001 v1.0
Homepage Trial Sections	index.html	Trial awareness, pre-screening CTA, compliance disclaimers	WEB-REC-001 v1.0
Trial Pre-Screening Interest Form	IntakeForm.html	Non-enrolling pre-screening interest collection	WEB-PRESCREEN-001 v1.0
Clinical Trial Disclosures	trial.html#disclosures	Investigational status, risks, voluntary participation	WEB-REC-001 v1.0
Privacy Policy (trial sections)	privacy.html	Data handling, PHI, participant rights	As published
Terms of Use (trial sections)	terms.html	Medical disclaimer, trial participation terms	As published

5. Regulatory Framework

This study and its recruitment materials are designed to comply with applicable human subjects protection requirements, including:

21 CFR Part 50 — Protection of Human Subjects (informed consent)
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application (stem cell therapy arm)
21 CFR Part 812 — Investigational Device Exemptions (wearable BCI arm)
ICH E6(R2/R3) GCP — Good Clinical Practice for recruitment material approval and version control
HIPAA Privacy Rule — Protected health information safeguards at enrollment

6. Pre-Screening vs. Enrollment

Noah Tech distinguishes between pre-screening interest and formal study enrollment:

Pre-screening interest — Submitting the Trial Pre-Screening Interest Form authorizes the study team to contact you about potential eligibility. It is not informed consent and does not enroll you in the study.
Eligibility screening — Conducted under protocol procedures after recruitment opens and only after appropriate authorizations are in place.
Enrollment — Requires a signed IRB-approved Informed Consent Form and, where applicable, a HIPAA Authorization. Enrollment is voluntary and may be withdrawn at any time.

7. Participant Rights

Prospective and enrolled participants have the right to:

Receive accurate, non-misleading information about the study before deciding to participate
Ask questions of the study team or IRB of record at any time
Decline participation or withdraw without penalty to clinical care outside the study
Report concerns about study conduct to the IRB of record (contact details to be posted upon approval)
Request information about how personal data is collected and used per our Privacy Policy

8. Document Control

Version	Date	Author	Change Summary	IRB Status
IRB-DOC-001 v1.0		Regulatory Affairs / Web	Initial IRB documentation page; all submissions pending	Pending
WEB-REC-001 v1.0	July 1, 2026	Medical Writer / Regulatory	Registry-aligned trial page and homepage recruitment content	Pending
WEB-PRESCREEN-001 v1.0	July 1, 2026	Clinical Ops / Web	Trial pre-screening interest form; contact authorization language	Pending

9. After IRB Approval

When IRB approval is obtained, this page will be updated to include:

Confirmed IRB of record name, address, and contact information
IRB approval date and protocol/version reference numbers
Approved material version numbers (replacing “pending” status)
Expiration or continuing review dates, as applicable

Until that update is published, all recruitment materials on this website should be treated as pending IRB approval.

10. Study Team Contact

For questions about this study or IRB documentation:

Trial Team
Email: info@noahtech.life
Phone: (917) 740-0918
Sponsor: Noah Tech, Corp., 930 S 4th St Ste 209, Las Vegas, NV 89101, USA

Privacy inquiries: privacy@noahtech.life | Legal: legal@noahtech.life

Disclaimer: This IRB documentation page is provided for operational transparency. It does not replace IRB-approved informed consent materials, the official protocol, or the ClinicalTrials.gov registry record. Investigational stem cell therapy and BCI devices used in NCT07214974 are not FDA-approved for this indication.