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

Registration Number: NCT04339413

Lead Sponsor: Hoffmann-La Roche

Brief 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. 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 116

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Marguerite RoAD	Gantenerumab	Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
SCarlet RoAD	Gantenerumab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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 Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs	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	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	Up to Week 133
Number of Participants With Injection-Site Reactions	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	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.
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (56): Banner Sun Health Research Insitute
🇺🇸
Sun City, Arizona, United States
California Neuroscience Research Medical Group, Inc
🇺🇸
Sherman Oaks, California, United States
Accelerated Enrollment Solutions
🇺🇸
Orlando, Florida, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Bioclinica The Villages
🇺🇸
The Villages, Florida, United States
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
🇺🇸
Kalamazoo, Michigan, United States
Richmond Behavioral Associates
🇺🇸
Staten Island, New York, United States
Alzheimer's Memory Center
🇺🇸
Matthews, North Carolina, United States
Central States Research
🇺🇸
Tulsa, Oklahoma, United States
Neurology Clinic PC
🇺🇸
Cordova, Tennessee, United States
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Banner Sun Health Research Insitute
🇺🇸Sun City, Arizona, United States