Gantenerumab

Generic Name: Gantenerumab

Drug Type: Biotech

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 cause neurodegeneration, large efforts have gone into developing treatments to reduce Aβ aggregation and remove Aβ plaques. These treatments include the related antibodies aducanumab, which has been granted accelerated FDA approval, along with bapineuzumab, crenezumab, donanemab, lecanemab, and solanezumab, which are at varying stages of clinical development. Despite the clear association of Aβ aggregation with AD, treatments aimed at preventing Aβ aggregation or removing pre-existing Aβ plaques have shown little to no clinical benefit thus far and remain controversial.

Gantenerumab is a fully human IgG1κ monoclonal antibody derived from the MorphoSys HuCAL®-Fab1 phage display library and subsequently optimized by in vitro CDR cassette exchange. Gantenerumab binds to a unique Aβ epitope compared to other anti-Aβ antibodies and preferentially recognizes Aβ oligomers and fibrils over monomers.

Clinical Trials

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

Phase 2

Terminated

Conditions: Alzheimers Disease, Familial
Dementia
Alzheimers Disease

Interventions: Drug: Gantenerumab

First Posted Date: 2024-05-22

Last Posted Date: 2025-02-04

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 73

Registration Number: NCT06424236

Locations: 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
University of Alabama in Birmingham, Birmingham, Alabama, United States
🇺🇸
University of California San Diego Medical Center, La Jolla, California, United States

and more 14 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: Alzheimers Disease

Interventions: Drug: Placebo
Drug: Gantenerumab

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.

Phase 2

Completed

Conditions: Alzheimers Disease, Familial
Dementia
Alzheimers Disease

Interventions: Drug: Matching Placebo (Gantenerumab)
Drug: Matching Placebo (Solanezumab)
Drug: Gantenerumab
Drug: Solanezumab

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: Alzheimer Disease

Interventions: Drug: Gantenerumab

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: Alzheimer Disease

Interventions: Drug: Gantenerumab

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: Alzheimer Disease

Interventions: Drug: Gantenerumab

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: Alzheimer Disease

Interventions: Drug: Placebo
Drug: Gantenerumab

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: Alzheimer Disease

Interventions: Drug: Gantenerumab
Drug: Placebo

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: Healthy Participants

Interventions: Drug: Gantenerumab

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: Healthy Volunteer

Interventions: Drug: Gantenerumab
Drug: Placebo

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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