Clinical Trials List
Protocol NumberWN29922
NCT Number(ClinicalTrials.gov Identfier)NCT04374253
Completed
2018-06-01 - 2023-03-21
Phase III
Terminated6
ICD-10F03.90
Unspecified dementia without behavioral disturbance
ICD-10G30
Alzheimer's disease
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH PRODROMAL TO MILD ALZHEIMER’S DISEASE
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Trial Applicant
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Sponsor
ROCHE PRODUCTS LTD.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/15
Investigators and Locations
Co-Principal Investigator
- TA-FU CHEN Division of Neurology
- YA-FANG CHEN Division of Radiology
- RUOH-FANG YEN Division of Nuclear Medicine
- 高伊慧 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
Co-Principal Investigator
- Ching-Kuan Liu Division of Neurology
- Chiou-Lian Lai Division of Neurology
- MEI-CHUAN CHOU Division of Neurology
- Chien-Hsun Li Division of Neurology
- Cheng-Fang Hsieh Division of Neurology
- 吳孟霓 Division of Neurology
- PING SONG CHOU Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chon-Haw Tsai Division of Neurology
- Ming-Kuei Lu Division of Neurology
- Kang-Hsu Lin Division of Neurology
- Wei-Shih Huang Division of Neurology
- Yi-Ting Hsu Division of Neurology
- Ching-Hua Lu Lu Division of Neurology
- Hui-Chun Huang Division of Neurology
- Kuan-Fei Chen Division of Neurology
- Fu-Yu Lin Division of Neurology
- Jui-Cheng Chen Division of Neurology
- Yuh-Cherng Guo Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
Audit
CRO
Principal Investigator
Chin-Chang Huang
Linkou Chang Gung Medical Foundation
Taiwan National PI
黃錦章
Co-Principal Investigator
- KuoLun Huang Division of Neurology
- Tzu-Chen Yen Division of Nuclear Medicine
- Kun-Ju Lin Division of Nuclear Medicine
The Actual Total Number of Participants Enrolled
2 Terminated
Audit
None
Condition/Disease
Alzheimer Disease
Objectives
This is an open-label, multicenter, rollover study to evaluate the safety, tolerability, and efficacy of long-term administration of open-label gantenerumab in participants with AD who completed Study WN29922 or WN39658, either the double-blind or open-label extension (OLE) part.
Test Drug
GANTENERUMAB
Active Ingredient
GANTENERUMAB
Dosage Form
Solution for subcutaneous injection
Dosage
Vial
Endpoints
Number of Participants With at Least One Adverse Event (AE) and Serious Adverse Event (SAE) An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. A SAE is any AE that is fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug or a significant medical event in the investigator's judgment. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score C-SSRS= assesses lifetime suicidality of participant (at baseline) & any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation (intensity of ideation, behavior, & attempts with actual/potential lethality). Categories have yes/no responses, 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/Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior= "yes" to any of listed categories. Score of 0= no suicide risk. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. First dosing visit in OLE (first dosing in current study or OLE period of parent GRADUATE studies)=baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With Injection-Site Reactions (ISRs) An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, regardless of casual attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants Who Discontinued the Study Due an AE An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Adverse Event of Special Interest (AESI) An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. AEs that were considered to be of special interest for this study included cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law and suspected transmission of an infectious agent by the study drug. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With Post-baseline Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) Score C-SSRS= assesses lifetime suicidality of participant (at baseline) & any new instances of suicidality (since last visit). Structured interview prompts recollection of suicidal ideation (intensity of ideation, behavior, & attempts with actual/potential lethality). Categories have yes/no responses, 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/Interrupted Attempt; Actual Attempt (non-fatal); Completed Suicide. Suicidal ideation/behavior= "yes" to any of listed categories. Score of 0= no suicide risk. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here. First dosing visit in OLE (first dosing in current study or OLE period of parent GRADUATE studies)=baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by MRI ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. In ARIA-E, (E for oedema or effusion), oedema can be seen in different areas of the brain on MRI, representing fluid leakage into the brain parenchyma or sulcal spaces. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by MRI ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. ARIA-H (H for hemosiderosis) are small foci of signal loss observed on MRI sequences sensitive for paramagnetic tissue properties and comprise cerebral microbleeds (small foci of bleeding in the brain parenchyma) and leptomeningeal hemosiderosis (small foci of bleeding on the surface of the brain). These changes also occur sporadically in AD. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With Injection-Site Reactions (ISRs) An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product, regardless of casual attribution. Local injection reactions (or injection site reactions) are defined as AEs related to the injection site that occur during or within 24 hours after study drug administration that are judged to be related to the study drug injection. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants Who Discontinued the Study Due an AE An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Number of Participants With at Least One Adverse Event of Special Interest (AESI) An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of casual attribution. AEs that were considered to be of special interest for this study included cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law and suspected transmission of an infectious agent by the study drug. The first dosing visit in the OLE (first dosing in current study or first dosing in the OLE period of the parent GRADUATE studies) was considered as baseline (OLE Day 1). From Baseline (OLE Day 1) up to 14 weeks after the last dose (up to 134 weeks)
Inclution Criteria
Completed Study WN29922 or WN39658, either its double-blind part or OLE part, and did not discontinue study drug early
The participant should be capable of completing assessments either alone or with the help of the caregiver
Availability of a person (referred to as the "caregiver")
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of <1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
The participant should be capable of completing assessments either alone or with the help of the caregiver
Availability of a person (referred to as the "caregiver")
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception methods with a failure rate of <1% per year (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) during the treatment period and for at least 16 weeks after the final dose of gantenerumab
Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
Exclusion Criteria
Pregnant or breastfeeding, or intending to become pregnant during the study or within at least 16 weeks after the final dose of study drug
Prematurely discontinued from Study WN29922 or WN39658
Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
Evidence of disseminated leptomeningeal hemosiderosis
Evidence of intracerebral macrohemorrhage
Use of prohibited medication
Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
Prematurely discontinued from Study WN29922 or WN39658
Any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment
Received any investigational treatment other than gantenerumab during or since completion of Study WN29922 or WN39658, either its double-blind or OLE part
Evidence of disseminated leptomeningeal hemosiderosis
Evidence of intracerebral macrohemorrhage
Use of prohibited medication
Evidence of ARIA-E on the last MRI scan report in Study WN29922 or WN39658, either its double-blind or OLE part
The Estimated Number of Participants
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Taiwan
30 participants
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Global
1016 participants
