Ampalex (CX-516) Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Multiple clinical trials in Phase 2 and Phase 3 have evaluated Ampalex (CX-516) across neurodegenerative, neurodevelopmental, and psychiatric disorders, including schizophrenia, Fragile X syndrome, autism, Alzheimer's disease, dementia, and mild cognitive impairment. Sponsored by industry and government entities, including RespireRx and the National Institute of Neurological Disorders and Stroke, these completed studies assessed the safety, tolerability, and cognitive efficacy of CX-516 as both monotherapy and adjunctive treatment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00235352	COMPLETED	Schizophrenia	North Suffolk Mental Health Association	2002-02	PHASE2; PHASE3
NCT00040443	COMPLETED	Mild Cognitive Impairment	RespireRx	2002-04	PHASE2
NCT00235352	Completed	Schizophrenia	North Suffolk Mental Health Association\|RespireRx	2002-02	Phase 2\|Phase 3
NCT00054730	COMPLETED	Fragile X Syndrome; Autism	RespireRx	2002-06	PHASE2
NCT00001662	COMPLETED	Alzheimer's Disease; Dementia	National Institute of Neurological Disorders and Stroke (NINDS)	1996-12	PHASE2

(data from https://clinicaltrials.gov, updated on 2009-02-26)

Check the Ampalex (CX-516) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ampalex (CX-516) binds as a positive allosteric modulator to AMPA ionotropic glutamate receptors, enhancing glutamate-induced agonist currents and slowing channel desensitization kinetics. This enhancement of excitatory neurotransmission promotes synaptic plasticity and long-term potentiation in central neural circuits, providing a therapeutic mechanism to address cognitive deficits in clinical conditions such as schizophrenia, Alzheimer's disease, and mild cognitive impairment.

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>).