A Study to Evaluate the Pharmacodynamic (PD) Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer's Disease (AD)

A Phase II, Multicenter, Open-Label, Single Arm Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early (Prodromal to Mild) Alzheimer's Disease

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04592341

Enrollment

192

Registered

2020-10-19

Start date

2020-11-18

Completion date

2023-03-15

Last updated

2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

This is a Phase II, multicenter, open-label, single arm, PD study in participants with early (prodromal to mild) AD to evaluate the effect of a once weekly (Q1W) dosing regimen of gantenerumab on deposited amyloid as measured by change from baseline to Week 104 (primary) and Week 208 in brain amyloid positron emission tomography (PET). The administration of gantenerumab as a single injection of Q1W will be investigated in this study, to simplify the dosing regimen for participants.

Interventions

DRUGGantenerumab

Gantenerumab will be administered by SC injection at a dose of 120 mg Q4W for 12 weeks, followed by 255 mg Q4W for 12 weeks, and 255 mg Q2W for another 12 weeks, followed by the target dose 255 mg Q1W for up to Week 103 and an optional dose of 255 mg Q1W for up to Week 207.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Probable Alzheimer's Disease (AD) dementia or prodromal AD. * Availability of a reliable study partner (non-professional caregiver) who accepts to participate in study procedure throughout the study duration * The participant should be capable of completing all aspects of study assessments including MRI, clinical genotyping, and PET imaging, either alone or with the help of the study partner (non-professional caregiver). * Adequate visual and auditory acuitysufficient to perform the neuropsychological testing (eye glasses and hearing aids are permitted). * Evidence of AD pathological process, as confirmed by amyloid PET scan by qualitative read by the core/central PET laboratory. * Prodromal or mild symptomatology, as defined by a screening Mini-Mental State Examination (MMSE) score \>/=22 and Clinical Dementia Rating global score (CDR-GS) of 0.5 or 1.0, as well as a clinical dementia rating (CDR) memory domain score \>/=0.5. * If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 3 months prior to screening and until start of study treatment. * 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. * Agreement not to participate in other research studies for the duration of this trial, unless these are related Roche-sponsored non-interventional studies. * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods hat result in a failure rate of \< 1% per year during the treatment period and for at least 16 weeks after the final dose of study drug.

Exclusion criteria

* Any evidence of a condition other than AD that may affect cognition. * History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function. * History or presence of clinically evident cerebrovascular disease. * History or presence of posterior reversible encephalopathy syndrome. * History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent with a transient ischemic attack. * History of severe, clinically significant CNS trauma. * History or presence of intracranial mass that could potentially impair cognition. * Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae. * History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits. * History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder. * At risk for suicide in the opinion of the investigator. * Alcohol and/or substance abuse or dependants in past 2 years.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan	Baseline, Week 104	Screening amyloid PET scan was considered baseline evaluation.Brain amyloid load was quantified in terms of Standardized Uptake Value Ratio (SUVR),defined as ratio of tracer uptake in cortical composite target region of interest(ROI)to tracer uptake in reference ROI.Composite region: frontal,parietal,temporal,posterior cingulate cortex,anterior cingulate cortex. Reference ROI (whole cerebellum) was represented by weighted average of Cerebellum Ventral,Cerebellum Dorsal (left/right), Cerebellar White Matter.SUVR linearly transformed to standardized Centiloid Scale (CL) using formula CL=175.6xSUVR-174.2.CL ranges from \<0 to \>100, anchor points are 0=high-certainty amyloid negative scan and 100=amount of global amyloid deposition found in typical AD scan.

Secondary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From day of first dose up to 16 weeks after the last dose (up to 120 weeks)	AE: any untoward medical occurrence in participant administered pharmaceutical product, which does not necessarily have a causal relationship with treatment. Also, any unfavorable, unintended sign, symptom, or disease temporally associated with use of medicinal product, whether or not considered related to it. SAE: any AE that was fatal, life threatening, required prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to mother exposed to study treatment. This was a single-arm study and all participants received gantenerumab according to predefined universal up-titration scheme as follows: 120 mg Q4W (Day 1, Week (W) 4, and W8), then 255 mg Q4W (W 12, 16, and 20), then 255 mg Q2W for 12 weeks (W 24, 26, 28, 30, 32, and 34), followed by target dose of 255 mg Q1W (W 36 to 104). Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study.
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)	From day of first dose up to 16 weeks after the last dose (up to 120 weeks)	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 is assigned if no suicide risk is present. Score of 1 or higher= suicidal ideation or behavior. Categories with non-zero values are only reported here.
Number of Participants With Amyloid-Related Imaging Abnormalities-Edema (ARIA-E) Confirmed by Magnetic Resonance Imaging (MRI)	From day of first dose up to 16 weeks after the last dose (up to 120 weeks)	ARIA are an identified risk with anti-amyloid antibodies, including gantenerumab. These changes can be identified on brain MRI. The occurrences of imaging abnormalities in vasogenic edema and sulcal effusions (ARIA-E) were evaluated.
Number of Participants With Amyloid-Related Imaging Abnormalities-Haemosiderin Deposition (ARIA-H) Confirmed by Magnetic Resonance Imaging (MRI)	From day of first dose up to 16 weeks after the last dose (up to 120 weeks)	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.
Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	Weeks 36, 52, 76, 104	HAQ comprised 4 items completed by study partner capturing confidence (Q1), convenience (Q2), ease of use (Q3), and overall satisfaction (Q4) with administering medication. Response options Q1: Not at all confident, somewhat confident, confident, very confident; Q2: Not at all convenient, somewhat convenient, convenient, very convenient; Q3: Not at all easy, somewhat easy, easy, very easy; Q4:Not at all satisfied, somewhat satisfied, satisfied, very satisfied.
Number of Participants With Treatment-emergent Anti-Drug Antibodies to Gantenerumab	From day of first dose up to 16 weeks after the last dose (up to 120 weeks)	A participant with an ADA assay result from at least one post-baseline sample was defined as a post-baseline evaluable participant. Treatment Emergent ADA was defined as a participant with a negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result, or a participant with a positive ADA result at baseline who has at least one post-baseline titer results with at least a \>2.5-fold increase in titer compared to baseline greater than the baseline titer result.
Plasma Concentration of Subcutaneous (SC) Gantenerumab at Specified Timepoints	Day 4 of Week 1, Week 24, 36, 52, and 76	—
Change in Brain Amyloid Based on Different Dosing Frequency	Baseline up to Week 52	The change from baseline at Week 52 using the once-weekly dosing frequency was analysed using the centiloid scale. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. The range of centiloid values can be below 0 (negative) and greater than 100.
Number of Participants With Injection-Site Reactions (ISR)	From day of first dose up to 16 weeks after the last dose (up to 120 weeks)	An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product or other protocol-imposed intervention, regardless of attribution. Injection reactions (local and systemic) were defined as AEs that occured during or within 24 hours after study drug administration that were judged to be related to the study drug injection.

Countries

Belgium, France, Germany, Italy, Poland, Spain, United Kingdom, United States

Participant flow

Recruitment details

Participants took part in this study at 33 investigative centers in the United States, Poland, Spain, Belgium, France, Germany, Italy, and the United Kingdom from 18 November 2020 up to 15 March 2023.

Pre-assignment details

This was a single-arm study and all participants received gantenerumab according to predefined universal up-titration scheme as follows: 120 mg every 4 weeks (Q4W) (Day 1, Week (W) 4, and W8), then 255 mg Q4W (W 12, 16, and 20), then 255 mg Q2W for 12 weeks (W 24, 26, 28, 30, 32, and 34), followed by target dose of 255 mg Q1W (W 36 to 104). Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study.

Participants by arm

Arm	Count
Gantenerumab Participants received gantenerumab, SC injections with gradual up-titration starting at a dose of 120 mg, Q4W on Day 1, Week 4, and Week 8, then 255 mg, Q4W on Weeks 12, 16, and 20, and then 255 mg Q2W for 12 weeks (Weeks 24, 26, 28, 30, 32, and 34), followed by 255 mg Q1W up to Week 104 (Weeks 36 to 104).	192
Total	192

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	5
Overall Study	Death	1
Overall Study	Lost to Follow-up	3
Overall Study	other	4
Overall Study	Physician Decision	5
Overall Study	Study Terminated by Sponsor	5
Overall Study	Withdrawal by Subject	53

Baseline characteristics

Characteristic	Gantenerumab
Age, Continuous	70.5 years STANDARD_DEVIATION 8.1
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants
Race (NIH/OMB) White	176 Participants
Sex: Female, Male Female	97 Participants
Sex: Female, Male Male	95 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 192
other Total, other adverse events	144 / 192
serious Total, serious adverse events	26 / 192

Outcome results

Primary

Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan

Screening amyloid PET scan was considered baseline evaluation.Brain amyloid load was quantified in terms of Standardized Uptake Value Ratio (SUVR),defined as ratio of tracer uptake in cortical composite target region of interest(ROI)to tracer uptake in reference ROI.Composite region: frontal,parietal,temporal,posterior cingulate cortex,anterior cingulate cortex. Reference ROI (whole cerebellum) was represented by weighted average of Cerebellum Ventral,Cerebellum Dorsal (left/right), Cerebellar White Matter.SUVR linearly transformed to standardized Centiloid Scale (CL) using formula CL=175.6xSUVR-174.2.CL ranges from \<0 to \>100, anchor points are 0=high-certainty amyloid negative scan and 100=amount of global amyloid deposition found in typical AD scan.

Time frame: Baseline, Week 104

Population: ITT population set, included all enrolled participants (i.e., who gave informed consent, did not fail screening, and had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol), whether or not the participant received the assigned treatment. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Arm	Measure	Group	Value (MEAN)	Dispersion
Gantenerumab	Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan	Baseline	101.80 centiloid	Standard Deviation 29.8
Gantenerumab	Change From Baseline in Brain Amyloid Load at Week 104 as Measured by [18F] Florbetaben Positron Emission Tomography (PET) Scan	Change from Baseline at Week 104	-35.48 centiloid	Standard Deviation 16.39

Secondary

Change in Brain Amyloid Based on Different Dosing Frequency

The change from baseline at Week 52 using the once-weekly dosing frequency was analysed using the centiloid scale. The centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scan. The range of centiloid values can be below 0 (negative) and greater than 100.

Time frame: Baseline up to Week 52

Population: ITT population set, included all enrolled participants (i.e., who gave informed consent, did not fail screening, and had at least one Amyloid PET scan with a valid quantitative measurement performed with either florbetaben or flutemetamol), whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with data available for analysis.

Arm	Measure	Value (MEAN)	Dispersion
Gantenerumab	Change in Brain Amyloid Based on Different Dosing Frequency	-26.19 centiloid	Standard Deviation 17.6

Secondary

Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)

HAQ comprised 4 items completed by study partner capturing confidence (Q1), convenience (Q2), ease of use (Q3), and overall satisfaction (Q4) with administering medication. Response options Q1: Not at all confident, somewhat confident, confident, very confident; Q2: Not at all convenient, somewhat convenient, convenient, very convenient; Q3: Not at all easy, somewhat easy, easy, very easy; Q4:Not at all satisfied, somewhat satisfied, satisfied, very satisfied.

Time frame: Weeks 36, 52, 76, 104

Population: Opportunity for Home Dosing Safety-Evaluable Analysis Set (OH-SE) included all participants of the SE analysis set who did not discontinue the study drug before week 26. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q2:Convenient	38 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q1:Not at all confident	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q1:Somewhat confident	10 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q1:Confident	33 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q1:Very confident	29 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q1:Not at all confident	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q1:Somewhat confident	10 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q1:Confident	46 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q1:Very confident	92 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q1:Not at all confident	1 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q1:Somewhat confident	5 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q1:Confident	34 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q1:Very Confident	86 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q1:Not at all confident	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q1:Somewhat confident	2 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q1:Confident	6 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q1:Very Confident	21 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q2:Not at all convenient	1 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q2:Somewhat convenient	2 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q2:Convenient	13 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q2:Very convenient	56 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q2:Not at all convenient	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q2:Somewhat convenient	5 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q2:Very convenient	105 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q2:Not at all convenient	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q2:Somewhat convenient	3 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q2:Convenient	23 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q2:Very convenient	100 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q2:Not at all convenient	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q2:Somewhat convenient	1 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q2:Convenient	5 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q2:Very convenient	23 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q3:Not at all easy	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q3:Somewhat easy	10 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q3: Easy	31 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q3:Very easy	31 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q3:Not at all easy	1 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q3:Somewhat easy	17 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q3: Easy	45 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q3:Very easy	85 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q3:Not at all easy	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q3:Somewhat easy	7 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q3: Easy	37 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q3:Very easy	82 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q3:Not at all easy	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q3:Somewhat easy	3 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q3: Easy	5 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q3:Very easy	21 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q4:Not at all satisfied	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q4:Somewhat satisfied	3 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q4:Satisfied	26 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W36:Q4:Very satisfied	43 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q4:Not at all satisfied	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q4:Somewhat satisfied	8 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q4: Satisfied	44 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W52:Q4:Very satisfied	96 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q4:Not at all satisfied	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q4:Somewhat satisfied	3 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q4:Satisfied	38 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W76:Q4:Very satisfied	85 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q4:Not at all satisfied	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q4:Somewhat satisfied	0 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q4:Satisfied	8 Participants
Gantenerumab	Number of Caregiver or Study Partner With Responses to Home Administration Questionnaire (HAQ)	W104:Q4:Very satisfied	21 Participants

Secondary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in participant administered pharmaceutical product, which does not necessarily have a causal relationship with treatment. Also, any unfavorable, unintended sign, symptom, or disease temporally associated with use of medicinal product, whether or not considered related to it. SAE: any AE that was fatal, life threatening, required prolonged inpatient hospitalization, resulted in significant disability or resulted in a congenital anomaly to mother exposed to study treatment. This was a single-arm study and all participants received gantenerumab according to predefined universal up-titration scheme as follows: 120 mg Q4W (Day 1, Week (W) 4, and W8), then 255 mg Q4W (W 12, 16, and 20), then 255 mg Q2W for 12 weeks (W 24, 26, 28, 30, 32, and 34), followed by target dose of 255 mg Q1W (W 36 to 104). Data was collected and reported in single arm for each participant who started treatment as specified and either completed or discontinued study.