Alzheimer DiseasePhase 3NCT04339413
A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)
A Phase 3 study testing Gantenerumab in people with Alzheimer Disease, run by Hoffmann-La Roche at 56 sites in 17 countries.
Trial summary
The main purpose of the study was 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 were enrolled in Part 1 of this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Gantenerumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 56 sitesin 17 countries
- Study dates
- 22 May 2020to 4 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
56 sites in 17 countries.
56 sites in 17 countries
United States11 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Neurology Clinic PC
Cordova, Tennessee, 38018
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
Kalamazoo, Michigan, 49008
Alzheimer's Memory Center
Matthews, North Carolina, 28105
Accelerated Enrollment Solutions
Orlando, Florida, 32806
California Neuroscience Research Medical Group, Inc
Sherman Oaks, California, 91403
Richmond Behavioral Associates
Staten Island, New York, 10314
Banner Sun Health Research Insitute
Sun City, Arizona, 85351
University of South Florida
Tampa, Florida, 33612
Bioclinica The Villages
The Villages, Florida, 32162
Central States Research
Tulsa, Oklahoma, 74136
Spain7 sites
Hospital del Mar; Servicio de Neurologia
Barcelona, 08003
Fundación ACE; Servicio de Neurología
Barcelona, 08028
Hospital General Universitario de Elche; Servicio de Neurología
Elche, Alicante, 03203
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, 28041
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrassa, Barcelona, 08222
Hospital Universitario Dr. Peset; Servicio de Neurologia
Valencia, 46017
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, 46026
Canada5 sites
Centricity Research
Halifax, Nova Scotia, B3S 1N2
True North Clinical Research-Halifax
Halifax, Nova Scotia, B3S 1N2
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4
Alpha Recherche Clinique
Québec, G3K 2P8
Toronto Memory Program
Toronto, Ontario, M3B 2S7
Italy5 sites
Azienda Ospedaliera Spedali Civili; Scienze Neurologiche
Brescia, Lombardy, 25100
IRCCS ?Centro S. Giovanni di Dio? Fatebenefratelli -UO Alzheimer
Brescia, Lombardy, 25125
Irccs Multimedica Santa Maria; Unita' Di Neurologia
Castellanza, Lombardy, 21053
Fondazione San Raffaele Del Monte Tabor; Dipartimento Di Neurologia
Milan, Lombardy, 20132
Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica ? Dipartimento di Neuroscienze
Modena, Emilia-Romagna, 41126
United Kingdom4 sites
Llandough Hospital; Llandough Hospital Memory Team 3rd Floor Academic Building
Cardiff, CF64 2XX
Imperial Memory Unit, Charing Cross Hospital; Level 10 West, Department of Neurosciences
London, W6 8RF
Campus for Ageing & Vitality; Clincal Ageing Research Unit
Newcastle, NE4 5PL
Hollins Park Hospital
Warrington, WA2 8WA
Japan3 sites
Medical Corporation Hakuyokai Kashiwado Hospital
Chiba, 260-8656
Juntendo University Urayasu Hospital; Neurology
Chiba, 279-0021
National Hospital Organization Hiroshima-Nishi Medical Center
Hiroshima, 739-0696
Mexico3 sites
Hospital Mexico Americano
Guadalajara, Mexico CITY (federal District), 44610
Hospital Universitario; Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460
AVIX Investigación Clínica S.C
Monterrey, Nuevo León, 64710
Poland3 sites
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
Późna, 61-853
Przychodnia Specjalistyczna PROSEN
Warsaw, 01-231
Centrum Medyczne NeuroProtect
Warsaw, 01-684
South Korea3 sites
Inha University Hospital
Incheon, 22332
Seoul St Mary's Hospital
Seoul, 06591
Ewha Womans University Hospital (Seoul)
Seoul, 07804
Turkey (Türkiye)3 sites
Istanbul University Istanbul School of Medicine; Neurology
Istanbul, 34093
Dokuz Eylul University Medicine Faculty; Noroloji Departmani
Izmir, 35340
Ondokuz Mayis University School of Medicine; Neurology
Samsun, 55139
Australia2 sites
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, 3081
The Queen Elizabeth Hospital; Neurology
Woodville, South Australia, 5011
Russia2 sites
Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center
Saint Petersburg, Sankt-Peterburg, 190103
FSMEI HPE ?Military Medical Academy n.a. S.M.Kirov"of Minist
Saint Petersburg, Sankt-Peterburg, 194044
Argentina1 site
Instituto Neurologia Bs As
Ciudad Autonoma Buenos Aires, C1426ANZ
About this study
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
The main purpose of the study was 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 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received 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.
- Conditions
- Alzheimer Disease
- Being tested
- Gantenerumab
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GantenerumabDrug
Gantenerumab was administered as SC injection Q4W.
| Study group | Role | What they receive |
|---|---|---|
| SCarlet RoAD | Experimental | Participants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks. Receives: Drug: Gantenerumab |
| Marguerite RoAD | Experimental | Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. Receives: Drug: Gantenerumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab.
Measured: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0= no suicide risk present. Score of 1 or higher= suicidal ideation/behavior. Number of participants with any suicidal ideation/behavior were reported.
Measured: Baseline (Day 1), up to Week 104
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs
Measured: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs
Measured: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Measured: Up to Week 133
Number of Participants With Injection-Site Reactions
Measured: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants Who Discontinued Treatment Due to AEs
An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab.
Measured: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start22 May 2020
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
Why it 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339413
- Sponsor's protocol ID
- WN41874
- Status last verified
- Dec 2023
- First submitted
- 7 Apr 2020
- Last updated
- 18 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04339413
- Acronym / sponsor ID
- WN41874
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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).
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Posted 18 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study was 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 were enrolled in Part 1 of this study. Of these, participants who completed Week 104 visit in Part 1. Participants received 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCarlet RoAD | Experimental | Drug: GantenerumabParticipants enrolled from the open label extension (OLE) part of parent study WN25203, received gantenerumab, up to 1200 milligram (mg), subcutaneous (SC) injection, every 4 weeks (Q4W) for up to 129 weeks. |
| Marguerite RoAD | Experimental | Drug: GantenerumabParticipants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GantenerumabGantenerumab was administered as SC injection Q4W. | Drug | Marguerite RoAD, SCarlet RoAD |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab.
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline (Day 1), up to Week 104
C-SSRS=assessment tool used to assess lifetime suicidality of a participant (at baseline) as well as any new instances of suicidality (C-SSRS since last visit). Structured interview prompts recollection of suicidal ideation, including intensity of ideation, behavior, \& attempts with actual/potential lethality. Categories have binary responses (yes/no) \& include Wish to be Dead; Non-specific Active Suicidal Thoughts; Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent, Preparatory Acts and Behavior; Aborted Attempt; Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior is indicated by a "yes" answer to any of the listed categories. Score of 0= no suicide risk present. Score of 1 or higher= suicidal ideation/behavior. Number of participants with any suicidal ideation/behavior were reported.
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs
Time frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs
Time frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab
Time frame: Up to Week 133
Number of Participants With Injection-Site Reactions
Time frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
Number of Participants Who Discontinued Treatment Due to AEs
Time frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)
An AE was defined as any untoward medical occurrence in a participant administered with gantenerumab and which does not necessarily have a causal relationship with gantenerumab. SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above, and which does not necessarily have a causal relationship with gantenerumab.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
56 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gantenerumab in people with Alzheimer Disease, run by Hoffmann-La Roche at 56 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Spain, Canada, Italy, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.