Latrepirdine 2HCl Clinical Trials

Size	Price	Qty
10mg	USD 117

Clinical Trials

Multiple clinical trials evaluate the efficacy, safety, and pharmacokinetic profiles of latrepirdine across neurodegenerative indications, focusing primarily on Alzheimer's disease—including moderate to severe cases—and Huntington's disease. Research spans Phase I trials assessing drug formulations, pharmacokinetics, and abuse potential, alongside Phase III protocols investigating safety and therapeutic performance. Key study sponsors include Pfizer, Medivation, Inc., and Bigespas LTD, with individual trial recruitment statuses categorized as completed, terminated, or recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07251023	RECRUITING	Alzheimer Type Dementia	Bigespas LTD	2025-11-20	PHASE3
NCT01152216	TERMINATED	Alzheimer's Disease	Medivation, Inc.	2010-04	PHASE3
NCT01085266	TERMINATED	Huntington Disease	Medivation, Inc.	2010-02	PHASE3
NCT00954590	TERMINATED	Moderate to Severe Alzheimer	Medivation, Inc.	2009-10	PHASE3
NCT01066546	TERMINATED	Alzheimer's Disease	Pfizer	2010-04	PHASE3
NCT00975481	COMPLETED	Alzheimer's Disease; Huntington's Disease	Pfizer	2009-10	PHASE1
NCT00990613	COMPLETED	Alzheimer's Disease; Huntington's Disease	Pfizer	2009-10	PHASE1
NCT00988624	COMPLETED	Alzheimer's Disease; Huntington Disease	Pfizer	2009-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-12-10)

Check the Latrepirdine 2HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Latrepirdine acts as a multi-target modulator by binding to histamine, serotonin, and glutamate receptors while inhibiting L-type calcium channels and mitochondrial permeability transition pores, which blocks downstream excitotoxic signaling and neurotoxic beta-amyloid cascades. This multi-target blockade prevents mitochondrial dysfunction and cellular toxicity to preserve neuronal viability, offering therapeutic relevance for neurodegenerative disorders such as Alzheimer's disease and Huntington'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>).