Clinical Trials

Several clinical trials evaluate the therapeutic profile and safety of rivastigmine across neurodegenerative and psychiatric conditions, including Alzheimer's disease, Alzheimer's dementia, depressive disorder, methamphetamine abuse, and rivastigmine toxicity. Spanning Phase 1 safety evaluations, Phase 4 post-marketing studies, and unclassified or Not Applicable protocols, these investigations encompass both completed and actively recruiting statuses. Sponsored by pharmaceutical companies such as Novartis, government research bodies like NIDA, and academic medical centers, these studies reflect a broad scope of past and ongoing clinical research.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05768126 Recruiting
Depressive Disorder
UMC Utrecht|ZonMw: The Netherlands Organisation for Health Research and Development|St. Antonius Hospital|Tergooi Hospital
 2021-09-29 Phase 4
NCT01585272 Completed
Alzheimer''s Dementia
Novartis Pharmaceuticals|Novartis
 2012-08 Phase 4
NCT01073319 Completed
Methamphetamine Dependence|Substance Abuse|Methamphetamine Abuse
Baylor College of Medicine|National Institute on Drug Abuse (NIDA)
 2009-07 Phase 1
NCT01312363 Completed
Alzheimer''s Disease
Seoul National University Hospital|Seoul National University Bundang Hospital|Seoul St. Mary''s Hospital|Korea University|Bobath Memorial Hospital|Chung-Ang University Hosptial Chung-Ang University College of Medicine|Hanyang University|Kwandong University Myongji Hospital|Inha University Hospital|SungAe General Hospital|Ewha Womans University|Inje University|Hanyang University Seoul Hospital|Kyunghee University Medical Center|Hallym University Medical Center|Pusan National University Hospital|Konyang University Hospital|Wonkwang University Sanbon Medical Center|Yong-in Hyoja Geriatric Hospital|Jeju National University|Dong-A University Hospital
 2009-06 --
NCT00624663 Completed
Rivastigmine Toxicity
Tel-Aviv Sourasky Medical Center|Medical Corps Israel Defense Force
 2009-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rivastigmine tartrate acts as a reversible cholinesterase inhibitor that binds to acetylcholinesterase and butyrylcholinesterase, thereby blocking the enzymatic degradation of acetylcholine in the synaptic cleft and enhancing central cholinergic neurotransmission. This sustained elevation of cholinergic signaling promotes enhanced neuronal communication and cognitive preservation, providing therapeutic relevance for Alzheimer's dementia and related conditions evaluated in clinical trials for depressive disorder and substance abuse.

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.