Clinical Trials

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)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rivastigmine acts as a cholinesterase inhibitor that reversibly binds to acetylcholinesterase and butyrylcholinesterase, blocking the enzymatic hydrolysis of acetylcholine within synaptic clefts. This inhibition elevates central synaptic acetylcholine concentrations and restores neurotransmission, thereby mitigating cognitive decline in clinical trial indications such as Alzheimer's disease and Parkinson's disease dementia.

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>).

Note: Technical data last updated: Sep 1, 2026.