Creatine monohydrate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial is currently recruiting participants to evaluate creatine monohydrate supplementation for Alzheimer's disease, addressing cellular energy failure and neurodegenerative pathology. Carrying no assigned phase designation due to its focus on physiological mechanisms and cerebral bioenergetics, the study is sponsored by academic and non-profit institutions, specifically the University of Kansas Medical Center in partnership with the Alzheimer's Association.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05383833	Recruiting	Alzheimer''s Disease	University of Kansas Medical Center\|Alzheimer''s Association	2022-12-12	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Creatine serves as a key substrate within the phosphagen energy system, undergoing reversible phosphorylation by creatine kinase to preserve intracellular adenosine triphosphate pools during periods of high energy demand. This rapid regeneration of high-energy phosphate bonds maintains cellular metabolic homeostasis, which is critical for supporting compromised neuronal energy dynamics in 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>).