Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD) (NCT NCT04339413)

Last Updated: 2024-01-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

116 participants

Primary outcome timeframe

Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Results posted on

2024-01-18

Participant Flow

Participants took part in Part 1 of the study at 56 centers in the United States, Spain, Canada, Italy, Germany, Japan, Korea, Mexico, Poland, Turkey, Australia, Russia, Argentina, Switzerland, Chile, Denmark, and Netherlands from 22 May 2020 to 04 Jan 2023. The study was terminated before Part 2 was initiated.

A total of 116 participants rolled over in this study of which 115 participants received gantenerumab in part 1. 59 participants rolled over from OLE WN25203 \& 56 participants rolled over from WN28745. Due to negative pre-planned analysis of studies WN39658 \& WN29922, this study was terminated by sponsor, \& no participant was rolled over to Part 2.

Participant milestones

Participant milestones
Measure	SCarlet RoAD 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.	Marguerite RoAD Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Overall Study STARTED	59	57
Overall Study Safety Evaluable Population	59	56
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	58	57

Reasons for withdrawal

Reasons for withdrawal
Measure	SCarlet RoAD 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.	Marguerite RoAD Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Overall Study Reason Not Specified	2	7
Overall Study Study Terminated by Sponsor	30	33
Overall Study Progressive Disease	9	6
Overall Study Withdrawal by Subject	9	10
Overall Study Physician Decision	3	1
Overall Study Death	2	0
Overall Study Adverse Event	3	0

Baseline Characteristics

A Study to Evaluate the Safety and Tolerability of Long-term Administration of Gantenerumab in Participants With Alzheimer's Disease (AD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCarlet RoAD n=59 Participants 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.	Marguerite RoAD n=57 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.	Total n=116 Participants Total of all reporting groups
Age, Continuous	78.0 years STANDARD_DEVIATION 6.7 • n=99 Participants	75.2 years STANDARD_DEVIATION 8.3 • n=107 Participants	76.6 years STANDARD_DEVIATION 7.7 • n=206 Participants
Sex: Female, Male Female	36 Participants n=99 Participants	35 Participants n=107 Participants	71 Participants n=206 Participants
Sex: Female, Male Male	23 Participants n=99 Participants	22 Participants n=107 Participants	45 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=99 Participants	4 Participants n=107 Participants	13 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=99 Participants	53 Participants n=107 Participants	103 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	13 Participants n=107 Participants	13 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	56 Participants n=99 Participants	42 Participants n=107 Participants	98 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Population: Safety evaluable population included all the participants who received at least one dose of gantenerumab.

Outcome measures

Outcome measures
Measure	SCarlet RoAD n=59 Participants 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.	Marguerite RoAD n=56 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AE	54 Participants	49 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	11 Participants	10 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1), up to Week 104

Population: Safety evaluable population included all the participants who received at least one dose of gantenerumab. Overall number analyzed is the number of participants with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	SCarlet RoAD n=56 Participants 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.	Marguerite RoAD n=54 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline	3 Participants	0 Participants
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Week 24	2 Participants	0 Participants
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Week 52	1 Participants	0 Participants
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Week 76	0 Participants	1 Participants
Number of Participants With Change in Any Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Week 104	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Population: Safety evaluable population included all the participants who received at least one dose of gantenerumab.

Outcome measures

Outcome measures
Measure	SCarlet RoAD n=59 Participants 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.	Marguerite RoAD n=56 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) AEs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Population: Safety evaluable population included all the participants who received at least one dose of gantenerumab.

Outcome measures

Outcome measures
Measure	SCarlet RoAD n=59 Participants 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.	Marguerite RoAD n=56 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) AEs	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Week 133

Population: Safety evaluable population included all the participants who received at least one dose of gantenerumab.

Outcome measures

Outcome measures
Measure	SCarlet RoAD n=59 Participants 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.	Marguerite RoAD n=56 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Number of Participants With Anti-drug Antibody (ADA) to Gantenerumab	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Population: Safety evaluable population included all the participants who received at least one dose of gantenerumab.

Outcome measures

Outcome measures
Measure	SCarlet RoAD n=59 Participants 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.	Marguerite RoAD n=56 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Number of Participants With Injection-Site Reactions	14 Participants	7 Participants

PRIMARY outcome

Timeframe: Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133)

Population: Safety evaluable population included all the participants who received at least one dose of gantenerumab.

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.

Outcome measures

Outcome measures
Measure	SCarlet RoAD n=59 Participants 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.	Marguerite RoAD n=56 Participants Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Number of Participants Who Discontinued Treatment Due to AEs	3 Participants	0 Participants

Adverse Events

SCarlet RoAD

Serious events: 11 serious events

Other events: 43 other events

Deaths: 2 deaths

Marguerite RoAD

Serious events: 10 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."
Publication restrictions are in place

Restriction type: OTHER

Measure	SCarlet RoAD n=59 participants at risk Participants enrolled from the OLE part of parent study WN25203, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.	Marguerite RoAD n=56 participants at risk Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Cardiac disorders Bradycardia	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Cardiac disorders Ventricular tachycardia	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Gastrointestinal disorders Abdominal pain	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Gastrointestinal disorders Acute abdomen	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 2 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
General disorders Death	3.4% 2/59 • Number of events 2 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Infections and infestations COVID-19	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	3.6% 2/56 • Number of events 2 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Injury, poisoning and procedural complications Fall	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Injury, poisoning and procedural complications Femur fracture	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Injury, poisoning and procedural complications Wrist fracture	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Metabolism and nutrition disorders Dehydration	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Nervous system disorders Epilepsy	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Nervous system disorders Haemorrhagic stroke	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Nervous system disorders Myoclonus	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Nervous system disorders Seizure	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Psychiatric disorders Neuropsychiatric symptoms	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Renal and urinary disorders Acute kidney injury	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.

Measure	SCarlet RoAD n=59 participants at risk Participants enrolled from the OLE part of parent study WN25203, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.	Marguerite RoAD n=56 participants at risk Participants enrolled from the OLE part of parent study WN28745, received gantenerumab, up to 1200 mg, SC injection, Q4W for up to 129 weeks.
Gastrointestinal disorders Constipation	5.1% 3/59 • Number of events 3 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	8.9% 5/56 • Number of events 5 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Gastrointestinal disorders Diarrhoea	3.4% 2/59 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	5.4% 3/56 • Number of events 5 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
General disorders Injection site reaction	23.7% 14/59 • Number of events 183 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	12.5% 7/56 • Number of events 34 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
General disorders Pyrexia	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	5.4% 3/56 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Infections and infestations COVID-19	22.0% 13/59 • Number of events 14 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	17.9% 10/56 • Number of events 10 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Infections and infestations Nasopharyngitis	6.8% 4/59 • Number of events 5 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Infections and infestations Upper respiratory tract infection	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	5.4% 3/56 • Number of events 3 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Infections and infestations Urinary tract infection	13.6% 8/59 • Number of events 12 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	12.5% 7/56 • Number of events 10 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Injury, poisoning and procedural complications Fall	22.0% 13/59 • Number of events 20 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	14.3% 8/56 • Number of events 15 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	5.4% 3/56 • Number of events 3 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/59 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	7.1% 4/56 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Metabolism and nutrition disorders Decreased appetite	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	7.1% 4/56 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	5.4% 3/56 • Number of events 5 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Musculoskeletal and connective tissue disorders Back pain	3.4% 2/59 • Number of events 2 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	8.9% 5/56 • Number of events 5 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Nervous system disorders Dizziness	6.8% 4/59 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	1.8% 1/56 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Psychiatric disorders Agitation	8.5% 5/59 • Number of events 6 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	5.4% 3/56 • Number of events 3 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Psychiatric disorders Anxiety	6.8% 4/59 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	7.1% 4/56 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Psychiatric disorders Insomnia	1.7% 1/59 • Number of events 1 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	7.1% 4/56 • Number of events 5 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.
Skin and subcutaneous tissue disorders Dermatitis	5.1% 3/59 • Number of events 4 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.	0.00% 0/56 • Baseline [Day 1] up to 4 weeks after the last dose of study drug (Up to Week 133) Safety evaluable population included all the participants who received at least one dose of gantenerumab.