Clinical Trials

A clinical trial sponsored by an academic investigator at Northwestern University is currently evaluating parameters associated with Alzheimer's disease. Designated with a phase status of Not Applicable and enrolling by invitation, this non-interventional study explores the neural mechanisms of induced calmness using improvisatory music in individuals with Alzheimer's disease as well as healthy controls.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05477862 Enrolling by invitation
Alzheimer Disease
Northwestern University
 2023-10-15 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the BAI1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BAI1 functions as a direct allosteric inhibitor of BAX with a dissociation constant (Kd) of 15.0 ± 4 μM, preventing BAX conformational activation and its integration into the outer mitochondrial membrane. By suppressing mitochondrial outer membrane permeabilization, BAI1 blocks downstream cytochrome c release and caspase activation, thereby preventing apoptotic cell death that drives neuronal loss in conditions such as Alzheimer's disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.