Several clinical trials investigate diverse conditions, focusing primarily on neurocognitive disorders—such as Alzheimer's disease, vascular dementia, sleep disturbances, and pain management in dementia—alongside anesthesia airway complications, pediatric oncology infection risks, and cognitive changes associated with aging. Spanning Early Phase 1, Phase 2, and non-applicable phase designations, these studies are all currently classified as not yet recruiting. Research sponsors include prominent academic institutions, healthcare systems, and government organizations such as the National Institute on Aging, Mayo Clinic, Indiana University, and Insel Gruppe AG University Hospital Bern.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06298474 | Not yet recruiting | Dementia|Alzheimer Disease|Vascular Dementia |
Hopeful Aging |
2025-02-15 | Not Applicable |
| NCT06045988 | Not yet recruiting | Alzheimer Disease|Dementia|Sleep Disturbance |
Indiana University|Innovative Design Labs|University of Minnesota|Mayo Clinic|Regenstrief Institute Inc.|National Institute on Aging (NIA) |
2025-02-01 | Phase 2 |
| NCT06117176 | Not yet recruiting | Airway Complication of Anesthesia|Adverse Events |
Insel Gruppe AG University Hospital Bern|University of Bern|University of Lausanne Hospitals|Kantonsspital Aarau|Charite University Berlin Germany|Universitätsklinikum Hamburg-Eppendorf |
2025-01 | -- |
| NCT05940766 | Not yet recruiting | Pediatric Oncology Patients With Risk for Infections |
Insel Gruppe AG University Hospital Bern|ETH Zurich |
2024-10-01 | Not Applicable |
| NCT06370572 | Not yet recruiting | Dementia|Hip Pain|Emergency Department Patient|Pain in Advanced Dementia Scale |
University of Chicago|National Institute on Aging (NIA)|University of North Carolina Chapel Hill |
2024-08 | Not Applicable |
| NCT05457725 | Not yet recruiting | Neurocognitive Disorders|Aging|Cognitive Change |
University of Florida|National Institute on Aging (NIA) |
2024-07-01 | Early Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
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>).