Clinical Trials

Memantine hydrochloride has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4 across diverse indications, including Alzheimer disease, neurocognitive dysfunction, obsessive-compulsive disorder, neuropathic pain, and autism spectrum disorder. Supported by academic medical centers, university health systems, and pharmaceutical manufacturers such as Allergan and Tata Memorial Centre, these studies encompass recruiting, completed, active, and terminated protocols. Recent efforts include a Phase 3 trial on neurocognitive preservation and a Phase 2 study evaluating Alzheimer disease prevention.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04302870 RECRUITING
Motor Neuron Disease, Amyotrophic Lateral Sclerosis
University of Edinburgh
2020-02-27 PHASE2; PHASE3
NCT07560878 RECRUITING
Major Depression
Mclean Hospital
2026-03-11 EARLY_PHASE1
NCT07470606 NOT_YET_RECRUITING
Brain Tumor
The University of Texas Health Science Center at San Antonio
2026-03 PHASE2
NCT00262470 ACTIVE_NOT_RECRUITING
Tachycardia; Chronic Orthostatic Intolerance
Satish R. Raj
1997-04 PHASE1; PHASE2
NCT06727773 RECRUITING
Breast Cancer; Locally Advanced Breast Cancer; Cognitive Impairment; Cognitive Decline; Cognitive Change; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III
UNC Lineberger Comprehensive Cancer Center
2025-08-19 PHASE2
NCT07505979 NOT_YET_RECRUITING
Brain Metastases From Solid Tumors
National Taiwan University Hospital
2026-04 PHASE2
NCT07164794 NOT_YET_RECRUITING
Metastatic Castration-resistant Prostate Cancer (mCRPC); Prostate Cancer; Neuroendocrine Prostate Cancer (NEPC)
Bin Xu
2025-11 PHASE2
NCT07531940 NOT_YET_RECRUITING
Down Syndrome; Intellectual Disability
University Hospitals Cleveland Medical Center
2026-06 PHASE1
NCT05045950 RECRUITING
Brain Metastases
Medical College of Wisconsin
2021-11-17 PHASE2
NCT05013892 RECRUITING
Brain Metastases
Massachusetts General Hospital
2022-02-08 PHASE2
NCT07139834 RECRUITING
Major Depressive Disorder (MDD)
Jeffrey Miller
2026-06-01 PHASE1
NCT04539951 RECRUITING
Obsessive-Compulsive Disorder
Shanghai Mental Health Center
2020-09-22 PHASE2
NCT03550391 RECRUITING
Brain Metastases
Canadian Cancer Trials Group
2018-11-22 PHASE3
NCT02144584 ACTIVE_NOT_RECRUITING
Ischemic Stroke; Upper Extremity Weakness
University of Utah
2014-01 EARLY_PHASE1
NCT07248228 RECRUITING
Brain Metastases
Case Comprehensive Cancer Center
2026-07-09 PHASE2
NCT07251023 RECRUITING
Alzheimer Type Dementia
Bigespas LTD
2025-11-20 PHASE3
NCT07504198 NOT_YET_RECRUITING
Peripheral Nerve Disease
Tanta University
2026-03 PHASE2; PHASE3
NCT05063851 ACTIVE_NOT_RECRUITING
Alzheimer Disease
University of Virginia
2021-10-11 PHASE2
NCT06041789 RECRUITING
Osteoporosis
Duke University
2025-02-03 PHASE2
NCT06789757 RECRUITING
Hepatocellular Carcinoma
Inova Health Care Services
2025-02-25 PHASE2
NCT06007846 RECRUITING
Hepatocellular Carcinoma; Cirrhosis
Inova Health Care Services
2023-07-31 PHASE2; PHASE3
NCT04939597 ACTIVE_NOT_RECRUITING
Central Nervous System Carcinoma
Children's Oncology Group
2022-05-10 PHASE3
NCT04804644 RECRUITING
Metastatic Lung Small Cell Carcinoma; Metastatic Malignant Neoplasm in the Brain; Recurrent Lung Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8
NRG Oncology
2021-06-08 PHASE3
NCT05664464 RECRUITING
Glioblastoma
University of Zurich
2023-01-01 PHASE1; PHASE2
NCT05796752 ACTIVE_NOT_RECRUITING
Skin-Picking; Trichotillomania (Hair-Pulling Disorder)
University of Chicago
2023-08-02 PHASE2; PHASE3
NCT03527472 COMPLETED
Lupus Erythematosus, Systemic
Vanderbilt University Medical Center
2018-08-23 PHASE2
NCT06275035 RECRUITING
Neurocognitive Dysfunction
Tata Memorial Centre
2024-02-22 PHASE3
NCT06594172 NOT_YET_RECRUITING
Radiation Disease; Cognitive Impairment; Drug Effect
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
2024-09-10 PHASE2
NCT04966546 WITHDRAWN
Chronic Subdural Hematoma
University of New Mexico
2022-06-01 EARLY_PHASE1
NCT03553875 TERMINATED
Autism; Autism Spectrum Disorder; Nonverbal Learning Disability
Massachusetts General Hospital
2018-11-13 PHASE3
NCT05418049 ACTIVE_NOT_RECRUITING
Fragile X Syndrome
Children's Hospital Medical Center, Cincinnati
2022-09-08 PHASE2
NCT06679387 RECRUITING
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Ain Shams University
2024-10-30 PHASE2
NCT06914310 NOT_YET_RECRUITING
Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury (TBI)
Mansoura University
2025-03-25 PHASE2; PHASE3
NCT07417670 COMPLETED
Alzheimer Disease
Carnot Laboratories
2024-10-04 PHASE4
NCT04789915 RECRUITING
Psychosis; Negative Symptoms With Primary Psychotic Disorder
Bjorn H. Ebdrup
2021-05-26 PHASE1
NCT07351773 COMPLETED
Alzheimer's Disease(AD); Cognitive Dysfunction
Taizhou Second People's Hospital
2025-01-26
NCT04857983 COMPLETED
Schizophrenia; Schizoaffective Disorder
University of California, San Diego
2021-07-06 PHASE2; PHASE3
NCT06501638 COMPLETED
Atrial Premature Beats, Contractions, or Systoles
Shanghai East Hospital
2024-08-29 PHASE2
NCT01430351 TERMINATED
Glioblastoma; Gliosarcoma; Supratentorial Glioblastoma
M.D. Anderson Cancer Center
2011-09-14 PHASE1
NCT03703856 COMPLETED
Alzheimer Disease
University of California, San Diego
2019-01-31 PHASE4
NCT03342443 UNKNOWN
Cognitive Impairment
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2017-12-06 PHASE2; PHASE3
NCT04588246 TERMINATED
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Lung Small Cell Carcinoma; Metastatic Malignant Breast Neoplasm; Metastatic Malignant Digestive System Neoplasm; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Metastatic Renal Cell Carcinoma; Recurrent Brain Neoplasm; Stage IV Lung Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8
NRG Oncology
2021-08-05 PHASE3
NCT04687566 UNKNOWN
Amphetamine Addiction; Pharmacotherapy
National Cheng-Kung University Hospital
2020-08-11 PHASE2; PHASE3
NCT05430867 UNKNOWN
Treatment; Efficacy; Safety; Alzheimer Disease
First Affiliated Hospital Xi'an Jiaotong University
2022-07-01 PHASE4
NCT06337994 COMPLETED
Treatment of Cognitive Deficits After Traumatic Brain Injury
Assiut University
2024-01-01 PHASE3
NCT05538507 UNKNOWN
Alzheimer Disease; Mild Cognitive Impairment
Peking Union Medical College Hospital
2022-06-01 PHASE2
NCT05834231 UNKNOWN
Cancer
Mansoura University
2023-08 PHASE1; PHASE2
NCT06275035 Recruiting
Neurocognitive Dysfunction
Tata Memorial Centre
2024-02-22 Phase 3
NCT04801342 UNKNOWN
Metastatic Malignant Neoplasm to Brain
National Taiwan University Hospital
2021-04-01 PHASE2
NCT05531383 UNKNOWN
Traumatic Brain Injury
Minia University
2021-11-26
NCT03194906 COMPLETED
Glioma of Brain; Craniopharyngioma; Ependymoma; Germ Cell Tumor
St. Jude Children's Research Hospital
2017-11-07 PHASE2
NCT03954613 UNKNOWN
Alzheimer Disease; Cognitive Change
Neutec Ar-Ge San ve Tic A.Ş
2020-10-15 PHASE4
NCT04117178 COMPLETED
Dementia; Dementia With Lewy Bodies; Dementia in Parkinsons Disease; Dementia Alzheimers; Alzheimer Disease
Zealand University Hospital
2020-02-04 PHASE4
NCT05804279 Completed
Healthy
Hyundai Pharm
2022-12-28 Phase 1
NCT04538066 COMPLETED
Alzheimer Disease
Neurotrope Bioscience, Inc.
2020-08-30 PHASE2
NCT05015595 UNKNOWN
Obsessive-Compulsive Disorder
University of Roma La Sapienza
2021-09-01 PHASE3
NCT04217694 COMPLETED
Malignant Central Nervous System Neoplasm; Primary Central Nervous System Neoplasm
Mayo Clinic
2020-02-17 EARLY_PHASE1
NCT04792645 COMPLETED
Trichotillomania (Hair-Pulling Disorder); Dermatillomania
University of Chicago
2021-06-15 PHASE2
NCT03986424 COMPLETED
Vascular Dementia
Merz Pharmaceuticals GmbH
2018-01-23 PHASE3
NCT04033419 COMPLETED
Cognitive Decline; Chemo-brain
UNC Lineberger Comprehensive Cancer Center
2019-09-25 PHASE2
NCT03858270 UNKNOWN
Parkinson Disease
Wayne State University
2019-04-01 PHASE3
NCT03686774 UNKNOWN
Neuropathic Pain
University Hospital, Clermont-Ferrand
2019-02-15 PHASE2
NCT03779672 COMPLETED
Epileptic Encephalopathy, Childhood-Onset
Kenneth Myers, MD
2019-02-07 PHASE4
NCT05063851 Recruiting
Alzheimer Disease
University of Virginia
2021-10-11 Phase 2
NCT05015595 Unknown status
Obsessive-Compulsive Disorder
University of Roma La Sapienza
2021-09-01 Phase 3
NCT04737967 UNKNOWN
Oncology Pain; Chemotherapy-induced Peripheral Neuropathy
Mendel AI
2021-02-15 PHASE2; PHASE3
NCT04035798 UNKNOWN
Bipolar II Disorder
National Cheng-Kung University Hospital
2019-08-01 PHASE2; PHASE3
NCT02118727 COMPLETED
Amyotrophic Lateral Sclerosis; Frontal Temporal Dementia
University of Kansas Medical Center
2018-11-07 PHASE2
NCT02811627 COMPLETED
Autism Spectrum Disorder
University of Missouri-Columbia
2016-06 EARLY_PHASE1
NCT03860597 COMPLETED
Schizophrenia; Schizo Affective Disorder; Schizoaffective Disorder; Healthy
University of California, San Diego
2018-04-01 PHASE4
NCT02288000 TERMINATED
Alzheimer Disease; Battery
University Hospital, Lille
2016-09-14 PHASE1
NCT03247218 UNKNOWN
Sickle Cell Disease
HaEmek Medical Center, Israel
2018-02-02 PHASE2
NCT03729128 COMPLETED
Stimulants Use Disorder
Tzu-Yun Wang
2018-07-24 PHASE1; PHASE2
NCT02304302 COMPLETED
Down Syndrome; Intellectual Disability
University Hospitals Cleveland Medical Center
2014-10 PHASE2
NCT02630888 UNKNOWN
Bipolar Disorder
University of Sao Paulo
2014-08 PHASE2
NCT04698525 COMPLETED
Migraine Headache
Universidad Autonoma de San Luis Potosí
2019-02-15 PHASE3
NCT02580305 COMPLETED
Alzheimer's Disease
Suven Life Sciences Limited
2015-09 PHASE2
NCT03988803 COMPLETED
Healthy
Boehringer Ingelheim
2019-07-17 PHASE1
NCT04417543 COMPLETED
Epilepsy
Assiut University
2018-10-01 PHASE1
NCT03560245 COMPLETED
Alzheimer Disease
Neurotrope Bioscience, Inc.
2018-06-20 PHASE2
NCT01555697 COMPLETED
Schizophrenia
University of California, San Diego
2014-07 PHASE1; PHASE2
NCT03802162 COMPLETED
Alzheimer's Disease (AD)
Chong Kun Dang Pharmaceutical
2019-02-15 PHASE1
NCT01902004 COMPLETED
Mild Cognitive Impairment (MCI); Depression
University of California, Los Angeles
2013-10 PHASE4
NCT03670095 COMPLETED
Healthy
H. Lundbeck A/S
2018-08-28 PHASE1
NCT03316898 WITHDRAWN
Alzheimer's Disease
Allergan
2018-09-30 PHASE1
NCT03711825 COMPLETED
Alzheimer Disease; Gastric Retention; Healthy
Lyndra Inc.
2018-09-10 EARLY_PHASE1
NCT03168997 UNKNOWN
Alzheimer Disease
Wei Cuibai
2017-07-15 PHASE4
NCT02080364 TERMINATED
Alzheimer's Disease
vTv Therapeutics
2015-04 PHASE3
NCT03038035 UNKNOWN
Alzheimer Disease
National University Hospital, Singapore
2016-12 PHASE2
NCT03569579 COMPLETED
Central Nervous System Diseases
Chong Kun Dang Pharmaceutical
2018-04-16 PHASE1
NCT01972074 COMPLETED
Autism Spectrum Disorder
Massachusetts General Hospital
2015-02-17 PHASE3
NCT02360215 COMPLETED
Cognitive Impairment; Metastatic Malignant Neoplasm in the Brain; Solid Neoplasm
NRG Oncology
2015-07 PHASE3
NCT03468543 TERMINATED
Gastric Retention; Healthy
Lyndra Inc.
2017-07-26 EARLY_PHASE1
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
2015-01 PHASE3
NCT05102045 COMPLETED
Alzheimer Disease
Istanbul Medipol University Hospital
2016-09-01
NCT01519063 COMPLETED
Alcohol Drinking
Yale University
2012-01 PHASE2
NCT01656187 COMPLETED
Organic Memory Impairment
University of Texas Southwestern Medical Center
2012-01 PHASE4
NCT03043001 UNKNOWN
AOD Effects and Consequences
National Cheng-Kung University Hospital
2014-01-01 PHASE3
NCT03039842 UNKNOWN
Bipolar Disorder II
National Cheng-Kung University Hospital
2013-01-01 PHASE3
NCT02233556 UNKNOWN
Schizophrenia
National Taiwan University Hospital
2014-02
NCT03121820 COMPLETED
Bioequivalence, AUC, Cmax, Pharmacokinetics
Geropharm
2016-10-11 PHASE1
NCT02535611 COMPLETED
Ischemic Stroke; Excitotoxicity; Memantine
Mazandaran University of Medical Sciences
2015-10 PHASE3
NCT02246075 WITHDRAWN
Alzheimer's Disease; Dementia; Cognition
FORUM Pharmaceuticals Inc
2015-07 PHASE2
NCT02234752 TERMINATED
Schizophrenia; Schizoaffective Disorder
Sheppard Pratt Health System
2014-09 PHASE2
NCT02553928 COMPLETED
Alzheimer Dementia (AD)
H. Lundbeck A/S
2015-10 PHASE4
NCT02001103 UNKNOWN
Schizophrenia
National Taiwan University Hospital
2014-01 PHASE3
NCT01585168 COMPLETED
Healthy
Yale University
2011-12 PHASE2
NCT02240589 COMPLETED
Traumatic Brain Injury
Indiana University
2014-12
NCT01409694 COMPLETED
Alzheimer Disease
University Hospital, Angers
2011-09 PHASE3
NCT02466191 COMPLETED
Pendular Nystagmus; Oculopalatal Tremor
Hospices Civils de Lyon
2015-06 PHASE4
NCT00956085 COMPLETED
Obsessive-Compulsive Disorder
New York State Psychiatric Institute
2009-08 PHASE2
NCT01372449 COMPLETED
Autism Spectrum Disorder
Evdokia Anagnostou
2011-12 PHASE2
NCT01677754 COMPLETED
Alzheimer's Disease
Hoffmann-La Roche
2012-10-24 PHASE2
NCT02136823 UNKNOWN
Chronic Spinal Cord Injury
Shirley Ryan AbilityLab
2009-06
NCT01844427 WITHDRAWN
ADHD; Executive Function Deficits (EFD's)
Massachusetts General Hospital
2013-07
NCT01032759 TERMINATED
Pain
Duke University
2009-12 PHASE4
NCT01461174 COMPLETED
Healthy
Qualissima
2011-11 PHASE1
NCT01849042 UNKNOWN
Alzheimer's Disease; Dementia
Konkuk University Medical Center
2013-01 PHASE4
NCT01333865 COMPLETED
Autism Spectrum Disorders
Massachusetts General Hospital
2010-01 PHASE4
NCT02570581 COMPLETED
Healthy
Centre Hospitalier Universitaire de Nice
2014-06 PHASE1
NCT01602185 COMPLETED
Neuropathic Pain
University Hospital, Clermont-Ferrand
2012-05 PHASE2
NCT01054599 COMPLETED
Epilepsy
American Academy of Neurology
2009-01
NCT02467556 COMPLETED
CRPS
Helsinki University Central Hospital
2011-03 PHASE4
NCT02001584 COMPLETED
Healthy Volunteers;; Obese, Otherwise Healthy Volunteers
Gedeon Richter Plc.
PHASE1
NCT01260467 TERMINATED
Glioblastoma
University of Rochester
2010-11 PHASE2
NCT01535040 COMPLETED
Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer; Tobacco Use Disorder
Wake Forest University Health Sciences
2012-08-01 PHASE2
NCT01592773 TERMINATED
Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Forest Laboratories
2012-10 PHASE2
NCT00703430 UNKNOWN
Alzheimer's Disease
Peking University
2008-03
NCT01536314 COMPLETED
Neuropathic Pain
University Hospital, Clermont-Ferrand
2012-02 PHASE3
NCT01592747 COMPLETED
Autistic Disorder; Autism; Asperger's Disorder; Asperger Syndrome; Autism Spectrum Disorders; Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
Forest Laboratories
2012-09 PHASE2
NCT01592786 COMPLETED
Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Forest Laboratories
2012-06 PHASE2
NCT01533493 COMPLETED
Attention Deficit Hyperactivity Disorder (ADHD); Executive Function Deficits (EFD)
Massachusetts General Hospital
2012-05
NCT01744444 COMPLETED
Pendular Nystagmus Patients With Multiple Sclerosis
Hospices Civils de Lyon
2012-11 PHASE2
NCT01052662 COMPLETED
Opioid Dependence
University of Massachusetts, Worcester
2009-10 PHASE2; PHASE3
NCT01626391 TERMINATED
Alzheimer's Disease
TauRx Therapeutics Ltd
2012-09 PHASE2
NCT01999894 COMPLETED
Autism; Pediatric Autism
Forest Laboratories
2009-11 PHASE2
NCT00545974 COMPLETED
Frontal Lobe Dementia; Frontotemporal Lobe Dementia; Semantic Dementia
University of California, San Francisco
2007-10 PHASE4
NCT01188148 COMPLETED
Bipolar Disorders
National Cheng-Kung University Hospital
2009-08 PHASE2; PHASE3
NCT01653457 UNKNOWN
Fibromyalgia
Aragon Institute of Health Sciences
2012-09 PHASE3
NCT00476008 COMPLETED
Alzheimer's Disease
Florida Atlantic University
2007-07 PHASE4
NCT00584948 COMPLETED
Fragile X-Associated Tremor/Ataxia Syndrome; Fragile X Premutation Carriers
University of California, Davis
2007-09
NCT00235716 COMPLETED
Alzheimer's Disease
US Department of Veterans Affairs
2007-08 PHASE3
NCT00872898 COMPLETED
Autism
Forest Laboratories
2009-04 PHASE2
NCT01458470 COMPLETED
Huntington Disease
University of British Columbia
2011-09 PHASE2
NCT00594737 COMPLETED
Frontotemporal Dementia
Tiffany Chow, MD
2007-10 PHASE3
NCT00880685 COMPLETED
Kleptomania
University of Chicago
2009-03 PHASE2
NCT01392287 COMPLETED
Major Depressive Disorder
Mclean Hospital
2010-05 PHASE1
NCT00866060 UNKNOWN
Moderate to Severe Alzheimer's Disease
King's College London
2008-02 PHASE4
NCT00986115 WITHDRAWN
Epilepsy
University of California, Davis
2010-07
NCT00551161 COMPLETED
Alzheimer Disease
Northwell Health
2007-08 PHASE4
NCT00585169 COMPLETED
Pathological Gambling
Yale University
2007-12 PHASE2
NCT00344682 COMPLETED
Depressive Disorder
University of Massachusetts, Worcester
2006-06 PHASE4
NCT00120874 COMPLETED
Alzheimer's Disease
NYU Langone Health
2006-08 PHASE4
NCT00933608 COMPLETED
Alzheimer's Disease
NYU Langone Health
2009-07 PHASE4
NCT00980408 COMPLETED
Healthy Individuals
University Hospital, Bonn
2008-06
NCT01261741 COMPLETED
Memory Disorder; Retention Disorder, Cognitive; Subjective Cognitive Impairment; Memory, Concentration or Attention Problems
Merz Pharmaceuticals GmbH
2010-11 PHASE2
NCT00476242 COMPLETED
Opioid Dependence; Heroin Dependence
New York State Psychiatric Institute
2008-06 PHASE2; PHASE3
NCT01112683 COMPLETED
Down Syndrome
University of Colorado, Denver
2008-07 PHASE4
NCT01041313 UNKNOWN
Pain, Post-operative
University of Washington
2010-01 PHASE4
NCT01038128 COMPLETED
Bulimia Nervosa; Body Dysmorphic Disorder
Mclean Hospital
2009-12
NCT00630955 COMPLETED
Alcohol Drinking
Yale University
2006-06 PHASE2
NCT00566852 COMPLETED
Cognitive/Functional Effects; Metastatic Cancer; Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific
Radiation Therapy Oncology Group
2008-03 PHASE3
NCT01074619 COMPLETED
Multiple Sclerosis
University Hospital, Caen
2005-09 PHASE3
NCT01189214 COMPLETED
Substance Abuse
National Cheng-Kung University Hospital
2009-03 PHASE3
NCT00305578 COMPLETED
Bipolar Depression
Indiana University
2005-08 PHASE4
NCT00409721 COMPLETED
Amyotrophic Lateral Sclerosis
University of Alberta
2007-03 PHASE2
NCT00462228 TERMINATED
Traumatic Brain Injury
University of Missouri-Columbia
2007-04 PHASE4
NCT00800709 COMPLETED
Alzheimer's Disease
Shanghai Mental Health Center
2008-07 PHASE4
NCT01108029 COMPLETED
Parkinson's Disease; Gait Disorders, Neurologic
University Hospital, Lille
2009-10 PHASE4
NCT00830375 COMPLETED
Compulsive Buying
University of Minnesota
2008-12-01 PHASE2
NCT00857233 TERMINATED
Alzheimer's Disease
H. Lundbeck A/S
2004-06 PHASE3
NCT01078844 TERMINATED
Autism; Asperger's Disorder; Pervasive Developmental Disorder NOS
Johns Hopkins University
2010-02
NCT00411398 COMPLETED
General Anxiety Disorder, Social Anxiety Disorder
State University of New York - Upstate Medical University
2006-12 PHASE3
NCT00857649 TERMINATED
Alzheimer's Disease
H. Lundbeck A/S
2003-12 PHASE3
NCT01876823 COMPLETED
Mild Cognitive Impairment; Major Depressive Disorder; Alzheimer's Disease
New York State Psychiatric Institute
2006-04 PHASE2; PHASE3
NCT00401167 COMPLETED
Alzheimer's Disease
Sunnybrook Health Sciences Centre
2006-11 PHASE4
NCT00242632 COMPLETED
Dementia
Stanford University
2004-06
NCT00586066 COMPLETED
Bipolar Disorder
Massachusetts General Hospital
2005-11 PHASE4
NCT00804271 COMPLETED
Alzheimer's Disease
Merz Pharmaceuticals GmbH
2008-12 PHASE3
NCT00988663 WITHDRAWN
Major Depressive Disorder
Jerrry L Lewis
2009-11
NCT01025466 COMPLETED
Alzheimer's Disease
Inha University Hospital
2008-12 PHASE4
NCT00652457 COMPLETED
Huntington's Disease
Jody Corey-Bloom, MD, PhD
2004-11-23 PHASE4
NCT00586573 COMPLETED
ADHD
Massachusetts General Hospital
2007-03 PHASE4
NCT00768261 COMPLETED
Dementia
Washington University School of Medicine
2004-11 PHASE4
NCT01020331 COMPLETED
Amyotrophic Lateral Sclerosis
Phoenix Neurological Associates, LTD
2005-06 PHASE2
NCT00371059 COMPLETED
DEMENTIA
East Kent Hospitals University NHS Foundation Trust
2007-09 PHASE4
NCT00255086 COMPLETED
Alzheimer Disease
Stanford University
2005-05 PHASE3
NCT00183729 COMPLETED
Depression
Eric Lenze
2005-08 PHASE4
NCT00928954 COMPLETED
Nystagmus
Case Western Reserve University
2005-02
NCT00649220 TERMINATED
Alzheimer's Disease
Merz Pharmaceuticals GmbH
2008-07 PHASE4
NCT00136786 COMPLETED
Tobacco Use Disorder
New York State Psychiatric Institute
2006-12 PHASE1
NCT00136747 COMPLETED
Tobacco Use Disorder
New York State Psychiatric Institute
2004-01 PHASE1
NCT00829816 COMPLETED
Alzheimer's Disease
Medivation, Inc.
2008-12 PHASE1
NCT00630500 COMPLETED
Dementia Associated With Parkinson's Disease; Dementia With Lewy Bodies
Helse Stavanger HF
2006-02 PHASE2
NCT00862940 COMPLETED
Alzheimer's Disease
H. Lundbeck A/S
2005-09 PHASE4
NCT00646204 COMPLETED
Parkinson's Disease
Baylor College of Medicine
2006-04 PHASE4
NCT00638027 COMPLETED
Multiple Sclerosis
University of Rochester
2006-07 PHASE4
NCT00300716 COMPLETED
Multiple Sclerosis; Cognition Disorders
Oregon Health and Science University
2004-04 PHASE2; PHASE3
NCT00439699 COMPLETED
Essential Tremor
VA Greater Los Angeles Healthcare System
2007-02 PHASE4
NCT00624026 COMPLETED
Alzheimer's Disease
Merz Pharmaceuticals GmbH
2007-11 PHASE3
NCT00855686 COMPLETED
Parkinson's Disease Dementia; Dementia With Lewy Bodies
H. Lundbeck A/S
2007-01 PHASE4
NCT00469456 COMPLETED
Alzheimer's Disease
Forest Laboratories
2007-04 PHASE4
NCT01921972 COMPLETED
Alzheimer's Disease
Charite University, Berlin, Germany
2004-11 PHASE4
NCT00294554 COMPLETED
Parkinson's Disease; Cognitive Impairment; Dementia
Johns Hopkins University
2006-04
NCT00125515 COMPLETED
Opioid Dependence
New York State Psychiatric Institute
2005-06 PHASE2
NCT00505167 COMPLETED
Dementia, Alzheimer Type
Hospital Miguel Servet
2007-07 PHASE4
NCT00264238 COMPLETED
Obsessive-Compulsive Disorder
Stanford University
2006-01 PHASE1; PHASE2
NCT00353665 COMPLETED
Amyotrophic Lateral Sclerosis
University of Lisbon
2005-07 PHASE2; PHASE3
NCT00148590 TERMINATED
Schizophrenia
M. Schaefer, MD
2005-11 PHASE3
NCT00148616 TERMINATED
Chronic Schizophrenia
M. Schaefer, MD
2004-04 PHASE3
NCT00638833 TERMINATED
Multiple Sclerosis
Clinica Universidad de Navarra, Universidad de Navarra
2007-09 PHASE2
NCT00757978 COMPLETED
Schizophrenia
Hospital de Clinicas de Porto Alegre
2006-01 PHASE4
NCT00674219 COMPLETED
Obsessive-Compulsive Disorder; Generalized Anxiety Disorder
University of California, Los Angeles
2005-05 PHASE3
NCT00640198 COMPLETED
Aphasia; Stroke
Gabinete Berthier y Martínez
2005-03 PHASE4
NCT00334906 COMPLETED
Alzheimer's Disease
Forest Laboratories
2005-07 PHASE4
NCT00322153 COMPLETED
Dementia of the Alzheimer's Type
Forest Laboratories
2005-06 PHASE3
NCT00315666 COMPLETED
Tension-Type Headache
Danish Headache Center
2006-05 PHASE3
NCT00134901 COMPLETED
Cocaine-Related Disorders
New York State Psychiatric Institute
2003-03 PHASE2
NCT00181298 COMPLETED
Systemic Lupus Erythematosus
Johns Hopkins University
2006-03
NCT00283309 TERMINATED
Mood; Memory Deficit
University of Texas Southwestern Medical Center
2005-11 PHASE4
NCT02258828 COMPLETED
PTSD
Sriram Ramaswamy
2005-07 PHASE4
NCT00168350 COMPLETED
Open-Angle Glaucoma
Allergan
2000-03 PHASE3
NCT00097916 COMPLETED
Alzheimer's Disease
Forest Laboratories
2004-09 PHASE3
NCT00186498 COMPLETED
Depressive Disorder, Major
Stanford University
2004-02
NCT00141882 COMPLETED
Open-Angle Glaucoma
Allergan
1999-03 PHASE3
NCT00246415 COMPLETED
Alcohol Dependence (Primary Condition); Alcohol Abuse
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
2002-11 PHASE2
NCT00106405 COMPLETED
Bipolar Disorder
Forest Laboratories
2005-02 PHASE2
NCT00187525 COMPLETED
Frontotemporal Lobar Degeneration
University of California, San Francisco
2004-05 PHASE4
NCT00097942 COMPLETED
Schizophrenia
Forest Laboratories
2004-08 PHASE2
NCT00234637 COMPLETED
Alzheimer's Disease
Novartis
2003-11 PHASE4
NCT00280774 COMPLETED
Physiological Effects of Drugs
University of Texas Southwestern Medical Center
2006-03 PHASE4
NCT00000867 COMPLETED
AIDS Dementia Complex; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
1996-12 PHASE2
NCT01196065 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2010-09 PHASE1
NCT00375778 COMPLETED
Parkinson's Disease
University of Aarhus
2005-04
NCT00330655 COMPLETED
Binge Eating Disorder
Mclean Hospital
2006-05 PHASE4
NCT00305903 COMPLETED
Alzheimer's Disease
Novartis
2006-03 PHASE4
NCT00040261 COMPLETED
Depression
National Institute of Mental Health (NIMH)
2002-06 PHASE3
NCT00368862 COMPLETED
Alcoholism; Depression
Finnish Institute for Health and Welfare
2005-12 PHASE4
NCT00196703 UNKNOWN
Aphasia; Stroke
Gabinete Berthier y Martínez
2005-03 PHASE4
NCT00240760 UNKNOWN
Down's Syndrome; Dementia; Learning Disabilities
King's College London
2005-10
NCT00200538 COMPLETED
Dementia
Nantes University Hospital
2005-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Memantine hydrochloride acts as an N-methyl-D-aspartate (NMDA) receptor antagonist, binding to the receptor channel to block pathological glutamate-mediated calcium influx and attenuate downstream excitotoxic signaling while additionally inhibiting cytochrome P450 enzymes CYP2B6 and CYP2D6. This receptor blockade mitigates glutamate-induced neuronal cell death and neurotoxicity, thereby providing clinical utility in managing neurocognitive dysfunction, Alzheimer disease, and chemotherapy-induced cognitive decline or neuropathic pain.

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.