Back to resultsA Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
Primary Purpose
Alzheimer Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Gantenerumab
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study
- Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study
- For Part 1 and Part 2:
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
- Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
- Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant
Exclusion Criteria:
- Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
- Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
- If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
- Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
- Pregnancy
- Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
- Evidence of intracerebral macrohemorrhage
- Part 2: Participants who have been discontinued from Part 1 of the study
Sites / Locations
- Banner Sun Health Research Insitute
- California Neuroscience Research Medical Group, Inc
- Accelerated Enrollment Solutions
- University of South Florida
- Bioclinica The Villages
- Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
- Richmond Behavioral Associates
- Alzheimer's Memory Center
- Central States Research
- Neurology Clinic PC
- Senior Adults Specialty Research
- Instituto Neurologia Bs As
- The Queen Elizabeth Hospital; Neurology
- Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
- Centricity Research
- True North Clinical Research-Halifax
- Kawartha Centre - Redefining Healthy Aging
- Toronto Memory Program
- Alpha Recherche Clinique
- Especialidades Medicas LYS
- Rigshospitalet, Hukommelsesklinikken
- Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze
- Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
- IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
- Irccs Multimedica Santa Maria; Unita' Di Neurologia
- Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
- Medical Corporation Hakuyokai Kashiwado Hospital
- Juntendo University Urayasu Hospital; Neurology
- National Hospital Organization Hiroshima-Nishi Medical Center
- Inha University Hospital
- Seoul St Mary's Hospital
- Ewha Womans University Hospital (Seoul)
- Hospital Mexico Americano
- Hospital Universitario; Dr. Jose E. Gonzalez
- AVIX Investigación Clínica S.C
- Brain Research Center B.V
- NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
- Przychodnia Specjalistyczna PROSEN
- Centrum Medyczne NeuroProtect
- Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
- FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Minist
- Hospital General Universitario de Elche; Servicio de Neurología
- Hospital Mutua De Terrasa; Servicio de Neurologia
- Hospital del Mar; Servicio de Neurologia
- Fundación ACE; Servicio de Neurología
- Hospital Universitario 12 de Octubre; Servicio de Neurologia
- Hospital Universitario Dr. Peset; Servicio de Neurologia
- Hospital Universitario la Fe; Servicio de Neurologia
- Felix Platter-Spital Medizin Geriatrie
- Istanbul University Istanbul School of Medicine; Neurology
- Dokuz Eylul University Medicine Faculty; Noroloji Departmani
- Ondokuz Mayis University School of Medicine; Neurology
- Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
- Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences
- Campus for Ageing & Vitality; Clincal Ageing Research Unit
- Hollins Park Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gantenerumab
Arm Description
Participants will continue receiving open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) up to Week 208.
Outcomes
Primary Outcome Measures
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI
Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Percentage of Participants with Injection-Site Reactions
Percentage of Participants Who Discontinued Treatment due to AEs
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04339413
Brief Title
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
Official Title
An Open-Label, Multicenter, Rollover Study to Evaluate the Safety and Tolerability of Long-Term Administration of Gantenerumab in Participants With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Decision to terminate development of Gantenerumab for treatment of prodromal/mild/early stage Alzheimer's disease following results of a pre-planned analysis of the safety and efficacy of Gant in Graduate I&II (WN29922/WN39658).
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
January 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is an open-label, multicenter, rollover study to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with AD. All participants who have completed the open-label extensions (OLEs) of Studies WN25203 or WN28745 will be eligible to participate in Part 1 of this study. Of these, participants who complete Week 104 visit in Part 1 will be eligible for Part 2 of this study. Participants will continue receiving open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) at the same dose as administered in the parent studies (part 1)/ Week 104 visit (part 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gantenerumab
Arm Type
Experimental
Arm Description
Participants will continue receiving open-label gantenerumab by subcutaneous (SC) injection every four weeks (Q4W) up to Week 208.
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Intervention Description
Gantenerumab will be administered as SC injection Q4W
Primary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212)
Title
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score
Time Frame
Baseline (Day 1) up to Week 208
Title
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)
Time Frame
Baseline (Day 1) up to Week 208
Title
Percentage of Participants with Amyloid-Related Imaging Abnormalities-Haemosiderin deposition (ARIA-H) Confirmed by MRI
Time Frame
Baseline (Day 1) up to Week 208
Title
Percentage of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Time Frame
Baseline (Day 1) up to Week 208
Title
Percentage of Participants with Injection-Site Reactions
Time Frame
Up to 4 weeks after the last dose of study drug (Baseline [Day 1] up to Week 212)
Title
Percentage of Participants Who Discontinued Treatment due to AEs
Time Frame
Baseline (Day 1) up to Week 208
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Part 1: Participants who completed the open-label extensions (OLEs) of studies WN25203 or WN28745 will be eligible to participate in Part 1 of the study
Part 2: All participants who have completed Week 104 visit in Part 1 will be eligible for Part 2 of the study
For Part 1 and Part 2:
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 16 weeks after the last dose of study drug
Agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
Availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant
Exclusion Criteria:
Prematurely discontinued from the OLEs of studies WN25203 or WN28745 or from study drug for any reason
Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
If the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest
Any investigational treatment other than gantenerumab during or since completion of the OLEs of studies WN25203 or WN28745
Pregnancy
Evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis)
Evidence of intracerebral macrohemorrhage
Part 2: Participants who have been discontinued from Part 1 of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Banner Sun Health Research Insitute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Accelerated Enrollment Solutions
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Bioclinica The Villages
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49008
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
Country
United States
Facility Name
Alzheimer's Memory Center
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Central States Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Senior Adults Specialty Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Instituto Neurologia Bs As
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Facility Name
The Queen Elizabeth Hospital; Neurology
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Centricity Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Facility Name
True North Clinical Research-Halifax
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Facility Name
Kawartha Centre - Redefining Healthy Aging
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9H 2P4
Country
Canada
Facility Name
Toronto Memory Program
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 2S7
Country
Canada
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Especialidades Medicas LYS
City
Santiago
ZIP/Postal Code
7560356
Country
Chile
Facility Name
Rigshospitalet, Hukommelsesklinikken
City
Koebenhavn Oe
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41126
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25100
Country
Italy
Facility Name
IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer
City
Brescia
State/Province
Lombardia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Irccs Multimedica Santa Maria; Unita' Di Neurologia
City
Castellanza
State/Province
Lombardia
ZIP/Postal Code
21053
Country
Italy
Facility Name
Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Medical Corporation Hakuyokai Kashiwado Hospital
City
Chiba
ZIP/Postal Code
260-8656
Country
Japan
Facility Name
Juntendo University Urayasu Hospital; Neurology
City
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
National Hospital Organization Hiroshima-Nishi Medical Center
City
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Ewha Womans University Hospital (Seoul)
City
Seoul
ZIP/Postal Code
07804
Country
Korea, Republic of
Facility Name
Hospital Mexico Americano
City
Guadalajara
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
44610
Country
Mexico
Facility Name
Hospital Universitario; Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
AVIX Investigación Clínica S.C
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Brain Research Center B.V
City
Amsterdam
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
City
Poznań
ZIP/Postal Code
61-853
Country
Poland
Facility Name
Przychodnia Specjalistyczna PROSEN
City
Warszawa
ZIP/Postal Code
01-231
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
City
Saint Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
FSMEI HPE "Military Medical Academy n.a. S.M.Kirov"of Minist
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche; Servicio de Neurología
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Mutua De Terrasa; Servicio de Neurologia
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08222
Country
Spain
Facility Name
Hospital del Mar; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Fundación ACE; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Dr. Peset; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Felix Platter-Spital Medizin Geriatrie
City
Basel
ZIP/Postal Code
4002
Country
Switzerland
Facility Name
Istanbul University Istanbul School of Medicine; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Dokuz Eylul University Medicine Faculty; Noroloji Departmani
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Ondokuz Mayis University School of Medicine; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
City
Cardiff
ZIP/Postal Code
CF64 2XX
Country
United Kingdom
Facility Name
Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Campus for Ageing & Vitality; Clincal Ageing Research Unit
City
Newcastle
ZIP/Postal Code
NE4 5PL
Country
United Kingdom
Facility Name
Hollins Park Hospital
City
Warrington
ZIP/Postal Code
WA2 8WA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
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