MeritEsterCudkowiczMDMSc

Neuromuscular Medicine, Neurodegenerative

Chair of Neurology at Massachusetts General Hospital and the Julieanne Dorn Professor of Neurology at Harvard Medical School (HMS).

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Office
Mass General Hospital
15 Parkman Street ACC 7
Boston, MA 02114
Phone+1 617-726-0813

Fax+1 617-726-4803

Summary

Dr. Merit Cudkowicz is a neurologist in Boston, MA and is affiliated with Massachusetts General Hospital. She received her medical degree from Harvard Medical School and has been in practice 35 years. She specializes in the care of people with ALS and neurotherapeutics. She co-founded and co-directed the Northeast ALS Consorrtium, a group now of over 150 centers who work collaboratively to accelerate the development of treatments for people with ALS. She has expertise in clinical trial design and conduct. She designed and leads the first platform trial in ALS, the Healey ALS Platform Trial. She is also the Principal Investigator for the Clinical Coordination Center for the NINDS supported NeuroNEXT phase II clinical trial network.

Education & Training

Brigham and Women's Hospital/Massachusetts General Hospital/Harvard Medical SchoolResidency, Neurology, 1991 - 1994
Beth Israel Deaconess Medical CenterInternship, Internal Medicine, 1990 - 1991
Harvard Medical SchoolClass of 1990

Certifications & Licensure

CT State Medical License Current
FL State Medical License 2022 - 2026
RI State Medical License 2021 - 2026
VT State Medical License 2021 - 2026
MA State Medical License 1994 - 2025
ME State Medical License 2021 - 2025
NH State Medical License 2021 - 2025
American Board of Psychiatry and Neurology Neurology

Awards, Honors, & Recognition

Ray Adams Lectureship American Neurological Association, 2019
America's Top Doctors Castle Connolly, 2012-2019
Boston Magazine Castle Connolly, 2012-2013

Clinical Trials

Determinants of Disease Severity in Amyotrophic Lateral Sclerosis Start of enrollment: 1998 Mar 01
Unknown status
A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS Start of enrollment: 2005 Oct 01
Completed
Phase 2
Pilot Study of Minocycline in Huntington's Disease Start of enrollment: 2006 Apr 01
Completed
Phase 2, Phase 3
Clinical Trial Ceftriaxone in Subjects With ALS Start of enrollment: 2006 Jul 01
Completed
Phase 3
A Multicenter, Double-Blind Study to Investigate the Safety and Efficacy of Arimoclomol in Volunteers With ALS
Withdrawn
Phase 2
Coenzyme Q10 in Huntington's Disease (HD) Start of enrollment: 2008 Mar 01
Terminated
Phase 3
Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS) Start of enrollment: 2008 Apr 01
Completed
Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis Start of enrollment: 2009 Jan 01
Completed
Phase 2, Phase 3
Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS) Start of enrollment: 2009 Jan 01
Terminated
Phase 2, Phase 3
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia Start of enrollment: 2009 May 01
Recruiting
Not Applicable
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211) Start of enrollment: 2009 Jul 01
Completed
Phase 2
Safety, Tolerability, and Activity Study of ISIS SOD1Rx to Treat Familial Amyotrophic Lateral Sclerosis (ALS) Caused by SOD1 Gene Mutations Start of enrollment: 2010 Jan 01
Completed
Phase 1
Clinical Trial Nuedexta in Subjects With ALS Start of enrollment: 2013 Apr 01
Completed
Phase 2
GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS) Start of enrollment: 2013 Aug 01
Completed
Phase 2
Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS Start of enrollment: 2014 May 01
Completed
Phase 2
Safety and Efficacy of Repeated Administrations of NurOwn® in ALS Patients Start of enrollment: 2017 Aug 28
Completed
Phase 3
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS Start of enrollment: 2018 Jun 21
Completed
Phase 3
Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension Start of enrollment: 2019 Jun 26
Terminated
Phase 3
Healey ALS Platform Trial: IC14 Arm
HEALEY ALS Platform Trial - Regimen C CNM-Au8 Start of enrollment: 2020 Jul 30
Completed
Phase 2, Phase 3
HEALEY ALS Platform Trial - Regimen A Zilucoplan Start of enrollment: 2020 Jul 29
Completed
Phase 2, Phase 3
HEALEY ALS Platform Trial - Regimen B Verdiperstat Start of enrollment: 2020 Jul 28
Completed
Phase 2, Phase 3
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Publications & Presentations

PubMed

Priorities and Recommendations to Make ALS a Livable Disease Emanating from the 2024 National Academies of Sciences, Engineering, and Medicine Report Living with ALS.
Ileana M Howard, Suma Babu, Chelsey Carter, Stacey A Sakowski, Jerome E Kurent
Annals of Neurology. 2024-12-01
Lessons from the HEALEY adaptive platform trial in amyotrophic lateral sclerosis.
Sabrina Paganoni, Brittney Harkey, Elisa Giacomelli, Merit Cudkowicz,
Nature Aging. 2024-11-01
Multicenter expanded access program for access to investigational products for amyotrophic lateral sclerosis.
Dylan V Neel, Clara Baselga-Garriga, Molly Benson, Mackenzie Keegan, Marianne Chase
Muscle & Nerve. 2024-08-01

Lectures

65th AAN Annual Meeting
American Academy of Neurology (AAN), San Diego, California - 3/16/2013

Other

Disease modifying treatment of amyotrophic lateral sclerosis
Cudkowicz ME, Galvez-Jimenez N, Choudry RB
http://www.uptodate.com/contents/disease-modifying-treatment-of-amyotrophic-lateral-sclerosis
UpToDate, Wolters Kluwer Health - 2012-12-03

Press Mentions

Calico Life Sciences Announces First Participant Dosed in Phase 1b Clinical Study Evaluating ABBV-CLS-7262 for the Treatment of Vanishing White Matter DiseaseApril 26th, 2023
Prilenia Shares Preliminary Topline Results from Phase 3 PROOF-HD Clinical Trial in Huntington's Disease and Data from Phase 2 HEALEY ALS Platform Trial of Pridopidine at the 75th American Academy of Neurology (AAN) Annual MeetingApril 25th, 2023
Prilenia Announces Topline Results for Pridopidine in Phase 2 ALS StudyFebruary 23rd, 2023
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Grant Support

Clinical Coordinating Center Network Of Excellence In Neuroscience Clinical TrialNational Institute Of Neurological Disorders And Stroke2011
Phase II/III Study Of Arimoclomol In The Treatment Of SOD1 Positive Familial?.Food And Drug Administration2011
Clinical Trial Of Ceftriaxone In Subjects With ALSNational Institute Of Neurological Disorders And Stroke2010–2011
Multi-Center Validation Of Biomarkers For Motor Neuron DiseaseNational Institute Of Neurological Disorders And Stroke2010
Multi-Center Validation Of Biomarkers For Motor Neuron DiseaseNational Institute Of Neurological Disorders And Stroke2009–2010
Generation And Characterization Of Amyotrophic Lateral Sclerosis IPS CellsNational Institute Of Neurological Disorders And Stroke2009–2010
Coenzyme Q10 In Huntington'S DiseaseNational Institute Of Neurological Disorders And Stroke2008–2010
Clinical Trial Of Ceftriaxone In ALSNational Institute Of Neurological Disorders And Stroke2006–2009
Clinical Trial: Open-Label Arimoclomol Extension ProtocolNational Center For Research Resources2008
Phase II/III Study Of Arimoclomol In The Treatment Of SOD1 Positive Familial?.Food And Drug Administration2008
Open-Label Arimoclomol Extension ProtocolNational Center For Research Resources2007
Identification Of Diagnostic Biomarkers And Therapeutic Agents For ALSNational Center For Research Resources2007
Safety And Pharmacokinetics Study Of Arimoclomol In ALSNational Center For Research Resources2006–2007
Multi-Dose Placebo-Controlled Phase I Study Of AEOL 10150 In Patients With ALSNational Center For Research Resources2006–2007
Coenzyme Q10 In Huntington'S DiseaseNational Institute Of Neurological Disorders And Stroke2005–2007
Double Blind Study Of Minocycline In HDFood And Drug Administration2005–2007
Safety Study Of Aeol10150 In Patients With Amyotrophic Lateral SclerosisNational Center For Research Resources2006
Safety And Dose Escalating Study Of Napb In ALSNational Center For Research Resources2006
Determ Of Biological Mrkrs In Cerebrospinal Fld Subj W/Amyotrophic Ltral ScleroNational Center For Research Resources2005
A Clinical Trial Of Coenzyme Q10 In Patients With Amyotrophic Lateral SclerosisNational Center For Research Resources2005
Metabolomic Signatures In ALSNational Institute Of Environmental Health Sciences2004–2005
Pilot Safety And Tolerability Study Of COQ10 In HD And In NormalNational Center For Research Resources2004–2005
Histamine Dihydrochloride In ALSNational Center For Research Resources2004–2005
Clinical Trial Of Celebrex In Subjects With Amyotrophic Lateral Sclerosis (ALS)National Center For Research Resources2004–2005
Clinical Trial Of Ceftriaxone In ALSNational Institute Of Neurological Disorders And Stroke2004
Clinical Trial Of Coenzyme Q10 In Patients With ALSNational Center For Research Resources2004
Clinical Trial Of Topiramate In ALSNational Institute Of Neurological Disorders And Stroke2000–2003
Topiramate Clinical Trial In Amyotrophic Lateral SclerosNational Center For Research Resources2000–2002
Rmethubdnf Intrathecal Infusion In ALSNational Center For Research Resources2000–2002
Coenzyme Q10 And Remacemide--Evaluation In Huntington'S DiseaseNational Center For Research Resources1998–2002
Risk Factors And Therapeutic Strategies In ALSNational Institute Of Neurological Disorders And Stroke1996–2000
Biological Markers In CSF In Subjects With Amyotrophic Lateral SclerosisNational Center For Research Resources1998–1999