Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic utility of rivastigmine across neurological and psychiatric indications, such as Alzheimer's disease, Parkinson's disease dementia, delirium, depressive disorder, and methamphetamine dependence. Encompassing completed, recruiting, and terminated recruitment statuses, these studies focus on key outcomes including safety, efficacy, and tolerability. They are sponsored by pharmaceutical corporations such as Novartis, academic medical centers, and government institutes like NIDA.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04366518 | RECRUITING | Hallucinations, Auditory; Psychosis |
Yale University |
2021-07-15 | EARLY_PHASE1 |
| NCT06382649 | RECRUITING | Anticholinergic Toxicity |
Washington University School of Medicine |
2026-06 | PHASE2 |
| NCT06399679 | SUSPENDED | Anticholinergic Toxicity |
Washington University School of Medicine |
2024-11-04 | PHASE2 |
| NCT03454646 | NOT_YET_RECRUITING | Alzheimer Disease; Cholinesterase Inhibitors |
University Hospital, Bordeaux |
2024-06-01 | PHASE4 |
| NCT07545382 | COMPLETED | Anticholinergic Delirium; Clozapine Poisoning; Antipsychotic Toxicity; CNS Depression; Hypoactive Delirium; Tricyclic Antidepressant Poisoning; Procyclidine Induced Delirium |
Alexandria University |
2025-12-08 | PHASE4 |
| NCT07208344 | RECRUITING | Alzheimer Disease (AD) |
Anhui Provincial Hospital |
2025-07-31 | EARLY_PHASE1 |
| NCT05768126 | UNKNOWN | Depressive Disorder |
UMC Utrecht |
2021-09-29 | PHASE4 |
| NCT06537076 | RECRUITING | Lewy Body Dementia |
Yonsei University |
2024-01-01 | PHASE2 |
| NCT06702124 | RECRUITING | Alzheimer Disease |
I.R.C.C.S. Fondazione Santa Lucia |
2023-12-01 | PHASE3 |
| NCT04226248 | COMPLETED | Parkinson Disease |
University of Bristol |
2020-01-02 | PHASE3 |
| NCT05853341 | COMPLETED | Healthy |
Luye Pharma Group Ltd. |
2023-05-02 | PHASE1 |
| NCT05883124 | COMPLETED | Bioequivalence |
SocraTec R&D GmbH |
2023-04-17 | PHASE1 |
| NCT07464340 | COMPLETED | Bioequivalence Study in Healthy Subjects |
Zodiac Produtos Farmaceuticos S.A. |
2023-05-12 | PHASE1 |
| NCT02989402 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2018-12-31 | PHASE4 |
| NCT02839642 | COMPLETED | Progressive Supranuclear Palsy (PSP) |
Assistance Publique Hopitaux De Marseille |
2016-07-26 | PHASE3 |
| 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 |
| NCT03915626 | COMPLETED | Bioavailability |
University of Maryland, Baltimore |
2019-10-04 | EARLY_PHASE1 |
| NCT03957174 | COMPLETED | Healthy |
University of Oxford |
2019-06-01 | |
| NCT04189666 | COMPLETED | Delirium |
Ain Shams University |
2019-11-18 | PHASE1; PHASE2 |
| NCT03840837 | COMPLETED | Parkinson Disease; Parkinson Disease Dementia |
University of Maryland, Baltimore |
2019-05-02 | PHASE4 |
| NCT02444637 | COMPLETED | Alzheimer Disease; CVA (Cerebrovascular Accident) |
National Neuroscience Institute |
2015-04 | PHASE4 |
| NCT03659435 | COMPLETED | Bioequivalence |
SocraTec R&D GmbH |
2018-08-22 | PHASE1 |
| NCT01856738 | TERMINATED | Parkinson's Disease |
Amsterdam UMC, location VUmc |
2013-11 | PHASE4 |
| NCT03573050 | COMPLETED | Bioequivalence |
SocraTec R&D GmbH |
2018-05-16 | PHASE1 |
| NCT02703636 | COMPLETED | Mild to Moderate Alzheimer's Disease |
Novartis Pharmaceuticals |
2016-05-09 | PHASE4 |
| NCT02374567 | TERMINATED | Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders |
Hannover Medical School |
2015-01 | PHASE3 |
| NCT02063269 | UNKNOWN | Alzheimer's Disease |
Seoul National University Hospital |
2014-02 | |
| NCT00223691 | COMPLETED | Autonomic Failure; Orthostatic Hypotension |
Vanderbilt University |
2002-03 | PHASE1 |
| NCT01380288 | COMPLETED | Alzheimer's Disease |
Dong-A University |
2011-06 | |
| NCT01670526 | COMPLETED | Traumatic Brain Injury; Cognitive Impairment |
VA Office of Research and Development |
2012-12 | PHASE3 |
| NCT01362686 | TERMINATED | Dementia; Alzheimer's Disease |
Indiana University |
2011-04 | |
| NCT01948791 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2014-08 | PHASE4 |
| NCT01487317 | COMPLETED | Delirium |
Assistance Publique - Hôpitaux de Paris |
2011-06 | PHASE3 |
| NCT01677754 | COMPLETED | Alzheimer's Disease |
Hoffmann-La Roche |
2012-10-24 | PHASE2 |
| NCT01585272 | COMPLETED | Alzheimer's Dementia |
Novartis Pharmaceuticals |
2012-08 | PHASE4 |
| NCT01519271 | COMPLETED | Parkinson's Disease; Mild Cognitive Impairment |
University of Pennsylvania |
2011-12 | PHASE4 |
| NCT01030692 | COMPLETED | Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Substance Abuse |
Baylor College of Medicine |
2009-01 | PHASE1 |
| NCT01614886 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2012-07 | PHASE3 |
| NCT02413554 | COMPLETED | Delirium |
Chung-Ang University Hospital |
2013-04 | PHASE4 |
| NCT01348282 | COMPLETED | Neurocognitive Disturbance; HIV Infection |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
2011-05 | PHASE4 |
| NCT01084135 | COMPLETED | Down Syndrome |
Duke University |
2009-11 | PHASE1; PHASE2 |
| NCT01529619 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2012-03 | PHASE4 |
| NCT01399125 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2011-07 | PHASE3 |
| NCT01602198 | TERMINATED | Mild Cognitive Disorder; Mild Cognitive Impairment |
The Cleveland Clinic |
2011-06 | |
| NCT01585272 | Completed | Alzheimer''s Dementia |
Novartis Pharmaceuticals|Novartis |
2012-08 | Phase 4 |
| NCT00948766 | COMPLETED | Alzheimer's Disease |
Novartis |
2009-07 | PHASE4 |
| NCT01696123 | COMPLETED | Alzheimer Disease |
Shahid Beheshti University of Medical Sciences |
2011-01 | PHASE2 |
| NCT01183806 | COMPLETED | Alzheimer Disease |
Federal University of Bahia |
2010-07 | PHASE3 |
| NCT01047579 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2010-04 | PHASE4 |
| NCT00767091 | COMPLETED | Parkinson's Disease; Apathy; no Dementia |
University Hospital, Lille |
2009-03 | PHASE3 |
| NCT00731224 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2008-07 | PHASE4 |
| NCT00506415 | COMPLETED | Alzheimer Disease |
Novartis Pharmaceuticals |
2007-06 | PHASE3 |
| NCT00988117 | COMPLETED | Parkinsons Disease With Dementia; Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems |
University of California, San Francisco |
2010-04 | PHASE4 |
| NCT00881205 | TERMINATED | Multiple Sclerosis; Cognitive Impairment |
Novartis Pharmaceuticals |
2009-04 | PHASE4 |
| NCT00623103 | COMPLETED | Parkinson's Disease Dementia |
Novartis |
2008-01 | PHASE3 |
| NCT01073319 | COMPLETED | Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse |
Baylor College of Medicine |
2009-07 | PHASE1 |
| NCT00835159 | COMPLETED | Delirium; Postoperative Cognitive Dysfunction |
NYU Langone Health |
2008-12 | PHASE4 |
| NCT00704301 | TERMINATED | Delirium |
UMC Utrecht |
2008-11 | PHASE4 |
| NCT00522015 | UNKNOWN | Progressive Supranuclear Palsy; Dementia |
University Hospital Tuebingen |
2008-02 | PHASE2 |
| NCT00748007 | COMPLETED | Down Syndrome |
National Taiwan University Hospital |
2008-01 | |
| NCT01025466 | COMPLETED | Alzheimer's Disease |
Inha University Hospital |
2008-12 | PHASE4 |
| 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 | -- |
| NCT00549601 | COMPLETED | Alzheimer's Disease |
Novartis |
2007-09 | PHASE4 |
| NCT00624663 | COMPLETED | Rivastigmine Toxicity |
Tel-Aviv Sourasky Medical Center |
2009-01 | |
| NCT00423085 | COMPLETED | Alzheimer's Disease |
Novartis Pharmaceuticals |
2007-01 | PHASE3 |
| NCT00766363 | COMPLETED | Alzheimer's Disease; Central Nervous System Diseases |
FORUM Pharmaceuticals Inc |
2008-10 | PHASE1 |
| NCT00624663 | Completed | Rivastigmine Toxicity |
Tel-Aviv Sourasky Medical Center|Medical Corps Israel Defense Force |
2009-01 | Not Applicable |
| NCT00622713 | COMPLETED | Alzheimer's Disease |
Novartis |
2008-01 | PHASE4 |
| NCT00627848 | COMPLETED | Alzheimer' Disease |
Kuopio University Hospital |
2007-03 | |
| NCT00561392 | COMPLETED | Alzheimer's Disease |
Novartis |
2007-11 | PHASE4 |
| NCT00599287 | TERMINATED | Delirium |
UMC Utrecht |
2008-02 | PHASE3 |
| NCT00428389 | COMPLETED | Alzheimer's Disease |
Novartis |
2007-01 | PHASE3 |
| NCT00669344 | COMPLETED | Cognitive Impairment |
Singapore General Hospital |
2006-02 | PHASE4 |
| NCT00158210 | COMPLETED | Substance-Related Disorders |
National Institute on Drug Abuse (NIDA) |
2006-05 | PHASE1 |
| NCT00219232 | COMPLETED | Alzheimer's Disease |
Novartis |
2003-02 | PHASE3 |
| NCT00130338 | COMPLETED | Vascular Dementia |
Novartis |
2002-02 | PHASE3 |
| NCT00099216 | COMPLETED | Vascular Dementia |
Novartis Pharmaceuticals |
2001-08 | PHASE3 |
| NCT00234637 | COMPLETED | Alzheimer's Disease |
Novartis |
2003-11 | PHASE4 |
| NCT00171795 | COMPLETED | Traumatic Brain Injury |
Novartis |
2002-11 | PHASE3 |
| NCT00219245 | COMPLETED | Traumatic Brain Injury With Persistent Cognitive Deficits |
Novartis |
2002-11 | PHASE4 |
| NCT01146041 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2004-02 | PHASE1 |
| NCT01146067 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2004-01 | PHASE1 |
| NCT00257868 | COMPLETED | Delirium |
University Hospital, Basel, Switzerland |
2006-01 | PHASE3 |
| NCT00000174 | COMPLETED | Alzheimer Disease; Cognition Disorders |
Novartis |
PHASE3 | |
| NCT00102284 | TERMINATED | Healthy |
University Hospital Muenster |
2004-03 | PHASE4 |
| NCT00134953 | TERMINATED | Cognitive Symptoms |
Novartis |
2003-01 | PHASE3 |
| NCT00102856 | SUSPENDED | Healthy |
University Hospital Muenster |
2005-01 | PHASE4 |
| NCT00305903 | COMPLETED | Alzheimer's Disease |
Novartis |
2006-03 | PHASE4 |
| NCT00099242 | COMPLETED | Alzheimer's Disease; Dementia, Alzheimer Type |
Novartis Pharmaceuticals |
2003-11 | PHASE3 |
| NCT00104442 | COMPLETED | Alzheimer's Disease |
Novartis |
2003-10 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2025-06-05)
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>).