Gantenerumab

Generic Name
Gantenerumab
Brand Names
-
Drug Type
Biotech
Chemical Formula
-
CAS Number
1043556-46-2
Unique Ingredient Identifier
4DF060P933
Background

Alzheimer's disease (AD) is the most common cause of dementia in elderly patients, with classical histopathological hallmarks including extracellular amyloid-beta (Aβ) plaques and intraneuronal neurofibrillary tangles (NFTs). As the classical view of AD pathology posits that Aβ accumulation triggers tau hyperphosphorylation and aggregation to form NFTs and c...

Associated Conditions
-
Associated Therapies
-

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia: A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation

First Posted Date
2024-05-22
Last Posted Date
2024-07-03
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
73
Registration Number
NCT06424236
Locations
🇫🇷

Hopital Roger Salengro - CHU Lille, Lille, Nord, France

🇦🇺

Neuroscience Research Australia, Randwick, New South Wales, Australia

🇺🇸

Yale University School of Medicine, New Haven, Connecticut, United States

and more 19 locations

A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer's Disease (AD)

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2022-02-25
Last Posted Date
2024-07-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
25
Registration Number
NCT05256134
Locations
🇺🇸

Visionary Investigators Network - Neurology Aventura, Aventura, Florida, United States

🇺🇸

Neuropsychiatric Research; Center of Southwest Florida, Fort Myers, Florida, United States

🇺🇸

Premiere Research Institute, West Palm Beach, Florida, United States

and more 60 locations

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation.

First Posted Date
2020-11-10
Last Posted Date
2022-09-22
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
194
Registration Number
NCT04623242
Locations
🇺🇸

University of California San Diego Medical Center, La Jolla, California, United States

🇺🇸

Washington University in St. Louis, Saint Louis, Missouri, United States

🇺🇸

Columbia University, New York, New York, United States

and more 22 locations

A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2020-10-19
Last Posted Date
2024-03-27
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
192
Registration Number
NCT04592341
Locations
🇧🇪

UZ Leuven Gasthuisberg, Leuven, Belgium

🇵🇱

Senior Sp. Z O.O. Poradnia Psychogeriatryczna, Sopot, Poland

🇫🇷

Gerontopole; Centre de Recherche clinique, Toulouse, France

and more 31 locations

A Study to Evaluate the Safety, Tolerability, and Efficacy of Long-Term Gantenerumab Administration in Participants With Alzheimer's Disease (AD)

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2020-05-05
Last Posted Date
2024-05-08
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1382
Registration Number
NCT04374253
Locations
🇺🇸

Research Center for Clinical Studies, Inc., Norwalk, Connecticut, United States

🇺🇸

Brain Matters Research, Inc., Delray Beach, Florida, United States

🇺🇸

Infinity Clinical Research, LLC, Sunrise, Florida, United States

and more 265 locations

A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2020-04-09
Last Posted Date
2024-01-18
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
116
Registration Number
NCT04339413
Locations
🇦🇷

Instituto Neurologia Bs As, Ciudad Autonoma Buenos Aires, Argentina

🇯🇵

Juntendo University Urayasu Hospital; Neurology, Chiba, Japan

🇵🇱

NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek, Pozna?, Poland

and more 53 locations

Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2018-02-23
Last Posted Date
2024-01-17
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
975
Registration Number
NCT03443973
Locations
🇺🇸

Irvine Center for Clinical Research, Irvine, California, United States

🇺🇸

SUNY Upstate Medical University, Syracuse, New York, United States

🇺🇸

Texas Neurology PA, Dallas, Texas, United States

and more 152 locations

Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2018-02-23
Last Posted Date
2024-01-30
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1053
Registration Number
NCT03444870
Locations
🇺🇸

Bradenton Research Center, Bradenton, Florida, United States

🇺🇸

Neurology Consultants of Dallas; Research Department, Dallas, Texas, United States

🇨🇦

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

and more 169 locations

Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2017-08-02
Last Posted Date
2018-12-12
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
114
Registration Number
NCT03236844
Locations
🇺🇸

PRA International Clinical Pharmacology Center (EDS US Clinic), Lenexa, Kansas, United States

🇺🇸

PRA, Marlton, New Jersey, United States

🇺🇸

PRA Health Sciences, Salt Lake City, Utah, United States

A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-08-29
Last Posted Date
2019-06-11
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
48
Registration Number
NCT02882009
Locations
🇺🇸

PRA International Clinical Pharmacology Center (EDS US Clinic), Lenexa, Kansas, United States

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