Dominantly Inherited Alzheimer Network Trial: An Opportun... | NCT06424236

NCT06424236

Secondary IDs

ID	Type	Description	Link
The Alzheimer's Association	Other Grant/Funding Number	DIAN TTU-12-243040
U01AG042791	U.S. NIH Grant/Contract		View source
2013-000307-17	EudraCT Number
R01AG046179	U.S. NIH Grant/Contract		View source
REec-2014-0817	Registry Identifier	Spanish Clinical Studies Registry
The Alzheimer's Association	Other Grant/Funding Number	DIAN-TU Tau-15-347219
GHR Foundation	Other Grant/Funding Number	File 4401
Alzheimer's Association	Other Identifier	HDE 18S84914
The Alzheimer's Association	Other Grant/Funding Number	DIAN-TU NG-16-434362
R56AG053267	U.S. NIH Grant/Contract		View source
U01AG059798	U.S. NIH Grant/Contract		View source
R01AG053267	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
Hoffmann-La Roche	INDUSTRY
Alzheimer's Association	OTHER
National Institute on Aging (NIA)	NIH

Oversight Module

Description Module

Detailed Description

Alzheimer's disease (AD) is defined by the presence of abnormal accumulations of amyloid protein (plaques) and tau protein (tangles) in the brain. The double-blind arm of DIAN-TU-001 Master protocol (NCT01760005) tested whether gantenerumab provided a clinical benefit by slowing the onset or the worsening of the disease. A clinical benefit was not observed in the double-blind part of the DIAN-TU-001 study. However, gantenerumab was associated with improvements in measures of amyloid and tau and an improvement in an overall measure of neurodegeneration (when nerve cells in the brain lose function over time). It is not known whether these changes may provide future clinical benefits. Based on this information, an exploratory Open Label Extension (OLE) will further study the effect of gantenerumab on these Alzheimer-related proteins and their relationship to disease progression.

After this final evaluation of study treatment with gantenerumab used in the gantenerumab / solanezumab double-blind arm of the Master protocol (NCT01760005), eligible participants from the placebo, solanezumab, and gantenerumab treatment groups in double-blind period were invited to participate in an OLE period to receive active gantenerumab study treatment as part of the DIAN-TU-001 Master protocol. The OLE period of the study planned to provide study treatment with gantenerumab for up to 3 years (36 months).

This study collected brain scans, blood, and spinal fluid tests (also called biomarkers), as well as safety, clinical and cognitive testing. The goal is to determine if gantenerumab has favorable effects on these tests to determine if and how much treatment may prevent or delay the symptoms of AD.

Update:

Based on the results of the completed studies of gantenerumab in sporadic AD in late 2022, it was decided to determine if dominantly inherited Alzheimer's disease (DIAD) participants in the DIAN-TU-001 OLE study were substantially clinically benefiting from gantenerumab high-dose treatment before the trial reached completion as the Gant program was being stopped.

An interim efficacy analysis of the DIAN-TU-001 OLE was performed to:

determine if gantenerumab OLE treatment and/or long-term treatment results in clinical benefit and determine the extent of amyloid removal compared to the double-blind period.
determine the potential effects of gantenerumab on clinical and cognitive measures to support decision-making regarding next steps for the DIAN-TU-001 OLE.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gantenerumab Open Label Extension	Experimental	Gantenerumab: Subcutaneously every 4 weeks, at escalating doses; at target, dosing was every 2 weeks	Drug: Gantenerumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gantenerumab	Drug	Open-label administered Subcutaneously every 4 weeks, at escalating doses; at target, dosing was every 2 weeks	Gantenerumab Open Label Extension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Composite [11C] Pittsburgh Compound B (PiB)-Positron Emission Tomography (PET) Composite Standardized Uptake Value Ratio (C-SUVR) at Weeks 52, 104 and 156	The composite PiB partial volume corrected C-SUVR was used as the biomarker endpoint for amyloid deposition using PET. The C-SUVR of precuneus, caudate, gyrus rectus, occipital cortex, parietal cortex, prefrontal cortex, and temporal cortex of brain regions was analyzed. Higher ratio indicate worse disease stage. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.	Baseline (Day 1) and Weeks 52, 104 and 156

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Clinical Dementia Rating (CDR) - Sum of Boxes Score at Weeks 52, 104 and 156	The efficacy of gantenerumab in reducing disease progression was assessed by CDR - sum of boxes. The CDR-SB score is considered a more detailed quantitative general index of cognition and function than the global CDR score. The CDR - sum of boxes is the sum score of 6 domains of cognitive function (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care), with the score of each domain ranging from 0 (no impairment) to 3 (severe impairment). The total score ranges from 0 (no impairment) to 18 (severe impairment). Higher score indicates worse performance. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 18-80 years of age
Individuals who know they have an Alzheimer's disease-causing mutation
Individuals who have participated in the double-blind period
In the opinion of the investigator and sponsor, treatment is not contraindicated for safety
Capable of receiving drug and appropriate clinical safety assessment
Able to undergo Magnetic Resonance Imaging (MRI), Lumbar Puncture (LP), Positron Emission Tomography (PET), and complete all study related testing and evaluations.
For women of childbearing potential, if partner is not sterilized, subject must agree to use effective contraceptive measures (hormonal contraception, intra-uterine device, sexual abstinence, barrier method with spermicide).
Adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
Has a Study Partner who in the investigator's judgment is able to provide accurate information as to the subject's cognitive and functional abilities, who agrees to provide information at the study visits which require informant input for scale completion.

Exclusion Criteria:

History or presence of brain MRI scans indicative of any other significant abnormality
Alcohol or drug dependence currently or within the past 1 year
Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would preclude MRI scan.
History or presence of clinically significant cardiovascular disease, hepatic/renal disorders, infectious disease or immune disorder, or metabolic/endocrine disorders
Anticoagulants except low dose (≤ 325 mg) aspirin.
Have been exposed to a monoclonal antibody targeting beta amyloid peptide within the past six months.
History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years.
Positive urine or serum pregnancy test or plans or desires to become pregnant during the course of the trial.
Subjects unable to complete all study related testing, including implanted metal that cannot be removed for MRI scanning, required anticoagulation and pregnancy.

Contacts/Locations Module

Name	Affiliation	Role
Randall J Bateman, MD	Washington University School of Medicine	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama in Birmingham		Birmingham	Alabama	35294	United States
University of California San Diego Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22784036	Background	Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11.
22672770

Label	URL
Expanded registry	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 milligram (mg) subcutaneous (SC) infusion every 2 weeks (Q2W) for 3 years.
FG001	Double-blind Solanezumab - OLE Gantenerumab

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 5, 2023	Oct 4, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

The safety analysis population included all participants who received at least 1 dose of study drug in the gantenerumab OLE period.

Arm/Group Information

ID	Title	Description
BG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
BG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
BG002	Double-blind Gantenerumab - OLE Gantenerumab	Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00049.7± 9.62 BG00147.0± 8.60 BG00250.3± 7.97 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00011 BG00114 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0011 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG00014 BG00126 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Composite [11C] Pittsburgh Compound B (PiB)-Positron Emission Tomography (PET) Composite Standardized Uptake Value Ratio (C-SUVR) at Weeks 52, 104 and 156

The composite PiB partial volume corrected C-SUVR was used as the biomarker endpoint for amyloid deposition using PET. The C-SUVR of precuneus, caudate, gyrus rectus, occipital cortex, parietal cortex, prefrontal cortex, and temporal cortex of brain regions was analyzed. Higher ratio indicate worse disease stage. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

The OLE gantenerumab modified intent-to-treat (mITT) analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point. Only participants analyzed at baseline and specific timepoints are reported.

Posted

Mean

Standard Deviation

ratio

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG002	Double-blind Gantenerumab - OLE Gantenerumab	Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

Units	Counts
Participants	OG00012 OG00120 OG00220

Title

Denominators

Categories

Week 52

- ParticipantsOG00012
- ParticipantsOG00118
- ParticipantsOG00214

Title	Measurements

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002	Week 52: Treatment group and visit were treated as categorical fixed effects factors and OLE baseline Composite [11C] PiB-PET SUVR score as continuous. An unstructured correlation pattern was used to estimate the variance-covariance of the within participant repeated measures. The Kenward-Roger method was used to estimate the denominator degrees of freedom.	Mixed Model for Repeated Measures (MMRM)		0.0117		Least square (LS) mean	-0.1166	Standard Deviation	0.29505	2-Sided	95	-0.2060	-0.0272					Superiority

Secondary

Change From Baseline in Clinical Dementia Rating (CDR) - Sum of Boxes Score at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by CDR - sum of boxes. The CDR-SB score is considered a more detailed quantitative general index of cognition and function than the global CDR score. The CDR - sum of boxes is the sum score of 6 domains of cognitive function (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care), with the score of each domain ranging from 0 (no impairment) to 3 (severe impairment). The total score ranges from 0 (no impairment) to 18 (severe impairment). Higher score indicates worse performance. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

The OLE gantenerumab mITT analysis set included all participants in the OLE who met mITT criteria using OLE baseline as the baseline reference point. Only participants analyzed at baseline and specific timepoints are reported.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

Secondary

Change From Baseline in Clinical Dementia Rating - Global Score at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by CDR - global score. The score ranges from 0 (minimum) to 3 (maximum). Higher score indicates worse performance. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG002	Double-blind Gantenerumab - OLE Gantenerumab

Secondary

Change From Baseline in Functional Assessment Scale (FAS) at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by FAS. This scale measured instrumental activities of daily living such as preparing balanced meals and managing personal finances. The intent of the FAS was to assess change in an individual's functional activities, relative to previously attained abilities, that were caused by cognitive dysfunction. The score ranges from 0 (minimum) to 30 (maximum). Higher score indicates worse performance. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

Secondary

Change From Baseline in Mini-Mental State Examination (MMSE) at Weeks 24, 52, 76, 104, 128 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by MMSE. The MMSE is a brief, quantitative measure of cognitive status in adults used to screen for cognitive impairment. The score ranges from 0 (minimum) to 30 (maximum). Lower score indicates worse performance. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and Weeks 24, 52, 76, 104, 128 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG002	Double-blind Gantenerumab - OLE Gantenerumab

Secondary

Change From Baseline in Tau Positron Emission Tomography Binding Partial Volume Corrected Standardized Uptake Value Ratio (Tau PET SUVR) at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by Tau PET SUVR. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

ratio

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG002	Double-blind Gantenerumab - OLE Gantenerumab	Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

Secondary

Change From Baseline in Phosphorylated Tau (pTau)-181 in Cerebrospinal Fluid (CSF) at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by CSF pTau-181. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

picogram per milliliter (pg/mL)

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG002	Double-blind Gantenerumab - OLE Gantenerumab	Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

Secondary

Change From Baseline in Neurofilament Light Chain (NfL) in Cerebrospinal Fluid at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by CSF NfL. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

pg/mL

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG002	Double-blind Gantenerumab - OLE Gantenerumab	Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

Secondary

Change From Baseline in Amyloid Beta1-42/40 Ratio in Cerebrospinal Fluid at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by CSF Amyloid Beta1-42/40. Baseline was defined as the last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

ratio

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG002	Double-blind Gantenerumab - OLE Gantenerumab	Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

Secondary

Change From Baseline in DIAN-TU Open Label Extension Cognitive Composite Score at Weeks 52, 104 and 156

The efficacy of gantenerumab in reducing disease progression was assessed by DIAN-TU OLE Cognitive Composite. The cognitive composite was calculated based on the below 4 components,

The wechsler adult intelligence scale-revised digit span (backward recall). Score ranges from 0 (minimum) to 7 (maximum).
The category fluency (animals) value. Score ranges from 0 to unlimited.
The wechsler adult intelligence scale digit symbol substitution test. Score ranges from 0 (minimum) to 93 (maximum).
The MMSE. Score ranges from 0 (minimum) to 30 (maximum).

Lower scores of each component indicate worse performance. The cognitive composite is a normalized z score and has score range - 4.11 to unlimited as one of the components has score range 0 to unlimited. Lower score indicates worse performance. Baseline was defined as last non-missing measurement prior to OLE study drug administration.

Posted

Mean

Standard Deviation

score on a scale

Baseline (Day 1) and Weeks 52, 104 and 156

ID	Title	Description
OG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.
OG001	Double-blind Solanezumab - OLE Gantenerumab

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-blind Placebo - OLE Gantenerumab	Eligible participants from placebo treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.	18	2	18	17	18
EG001	Double-blind Solanezumab - OLE Gantenerumab	Eligible participants from solanezumab treatment group in double-blind period entered OLE period to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.	27	4	27	27	27
EG002	Double-blind Gantenerumab - OLE Gantenerumab	Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.	28	3	28	27	28

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Non-cardiac chest pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Diverticulitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Metapneumovirus bronchiolitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Amyloid related imaging abnormality-oedema/effusion	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Epilepsy	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Vertebral artery occlusion	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Psychotic behaviour	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Deafness	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Eye discharge	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Vision blurred	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Visual impairment	Eye disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0022 events1 affected28 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected18 at risk EG0015 events5 affected27 at risk EG0026 events4 affected28 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected27 at risk EG0020 events0 affected28 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected18 at risk EG0016 events4 affected27 at risk EG00211 events4 affected28 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Toothache	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG0012 events2 affected27 at risk EG0022 events1 affected28 at risk
Asthenia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0014 events2 affected27 at risk EG0021 events1 affected28 at risk
Catheter site extravasation	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Chills	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Fatigue	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0014 events4 affected27 at risk EG0026 events5 affected28 at risk
Infusion site bruising	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Infusion site erythema	General disorders	MedDRA 26.1	Systematic Assessment	EG0006 events2 affected18 at risk EG0018 events2 affected27 at risk EG0026 events5 affected28 at risk
Infusion site nodule	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Infusion site oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Infusion site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Infusion site pruritus	General disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Injection site bruising	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0023 events2 affected28 at risk
Injection site discolouration	General disorders	MedDRA 26.1	Systematic Assessment	EG0005 events2 affected18 at risk EG0011 events1 affected27 at risk EG0023 events3 affected28 at risk
Injection site erythema	General disorders	MedDRA 26.1	Systematic Assessment	EG00097 events8 affected18 at risk EG001247 events17 affected27 at risk EG002367 events17 affected28 at risk
Injection site haemorrhage	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Injection site induration	General disorders	MedDRA 26.1	Systematic Assessment	EG0005 events2 affected18 at risk EG0014 events4 affected27 at risk EG00243 events4 affected28 at risk
Injection site mass	General disorders	MedDRA 26.1	Systematic Assessment	EG00014 events2 affected18 at risk EG0011 events1 affected27 at risk EG00221 events1 affected28 at risk
Injection site oedema	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG00128 events1 affected27 at risk EG00280 events3 affected28 at risk
Injection site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG00118 events5 affected27 at risk EG00228 events9 affected28 at risk
Injection site pruritus	General disorders	MedDRA 26.1	Systematic Assessment	EG00016 events5 affected18 at risk EG00135 events5 affected27 at risk EG00288 events8 affected28 at risk
Injection site reaction	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0017 events2 affected27 at risk EG00212 events5 affected28 at risk
Injection site swelling	General disorders	MedDRA 26.1	Systematic Assessment	EG00024 events5 affected18 at risk EG001100 events7 affected27 at risk EG00247 events11 affected28 at risk
Injection site urticaria	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected27 at risk EG0022 events2 affected28 at risk
Injection site warmth	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events1 affected27 at risk EG0025 events2 affected28 at risk
Malaise	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events3 affected27 at risk EG0020 events0 affected28 at risk
Oedema peripheral	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0023 events3 affected28 at risk
Puncture site erythema	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0024 events2 affected28 at risk
Puncture site pain	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0014 events3 affected27 at risk EG0024 events4 affected28 at risk
Puncture site pruritus	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0023 events1 affected28 at risk
Pyrexia	General disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0025 events4 affected28 at risk
Surgical failure	General disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Hypersensitivity	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0020 events0 affected28 at risk
Seasonal allergy	Immune system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events1 affected27 at risk EG0023 events3 affected28 at risk
Chronic sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0004 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
COVID-19	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG00010 events8 affected18 at risk EG00116 events14 affected27 at risk EG00217 events15 affected28 at risk
Ear infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0022 events2 affected28 at risk
Herpes zoster	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Influenza	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected27 at risk EG0022 events2 affected28 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected18 at risk EG0012 events2 affected27 at risk EG0025 events5 affected28 at risk
Oral herpes	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0024 events2 affected28 at risk
Pneumonia	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0020 events0 affected28 at risk
Pulpitis dental	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Sinusitis	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0009 events5 affected18 at risk EG0019 events6 affected27 at risk EG0027 events7 affected28 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0007 events4 affected18 at risk EG0013 events2 affected27 at risk EG00214 events8 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected27 at risk EG0024 events3 affected28 at risk
Viral diarrhoea	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Viral infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events3 affected27 at risk EG0020 events0 affected28 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events1 affected27 at risk EG0021 events1 affected28 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0015 events4 affected27 at risk EG0020 events0 affected28 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0013 events2 affected27 at risk EG0021 events1 affected28 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0021 events1 affected28 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected18 at risk EG0017 events2 affected27 at risk EG0028 events3 affected28 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0020 events0 affected28 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected18 at risk EG0013 events2 affected27 at risk EG0023 events3 affected28 at risk
Procedural headache	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0024 events3 affected28 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected27 at risk EG0024 events2 affected28 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0022 events2 affected28 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Blood cholesterol increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Blood pressure increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0023 events3 affected28 at risk
Hepatic enzyme increased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Red blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Urine analysis abnormal	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Weight decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0021 events1 affected28 at risk
White blood cell count decreased	Investigations	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Ankle deformity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG0013 events3 affected27 at risk EG0024 events4 affected28 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected18 at risk EG0015 events5 affected27 at risk EG0027 events6 affected28 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Ligament pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0025 events3 affected28 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected27 at risk EG0022 events2 affected28 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected27 at risk EG0025 events4 affected28 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG0017 events5 affected27 at risk EG0020 events0 affected28 at risk
Amyloid related imaging abnormality-oedema/effusion	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00012 events7 affected18 at risk EG0018 events6 affected27 at risk EG0029 events5 affected28 at risk
Balance disorder	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Brain fog	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Brain stem microhaemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Cerebellar microhaemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Cerebral microhaemorrhage	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0004 events3 affected18 at risk EG0014 events2 affected27 at risk EG0020 events0 affected28 at risk
Dizziness	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0005 events3 affected18 at risk EG0013 events3 affected27 at risk EG0022 events1 affected28 at risk
Dysgeusia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Dyskinesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0003 events2 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Electric shock sensation	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG00015 events5 affected18 at risk EG00120 events8 affected27 at risk EG00232 events11 affected28 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0021 events1 affected28 at risk
Migraine	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0004 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Myoclonus	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Parosmia	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Presyncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Sinus headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0024 events2 affected28 at risk
Status migrainosus	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Syncope	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0020 events0 affected28 at risk
Tension headache	Nervous system disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Aggression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected27 at risk EG0021 events1 affected28 at risk
Anxiety	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0003 events3 affected18 at risk EG0013 events3 affected27 at risk EG0021 events1 affected28 at risk
Attention deficit hyperactivity disorder	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Confusional state	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Delirium	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Depressed mood	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events2 affected27 at risk EG0020 events0 affected28 at risk
Depression	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0002 events2 affected18 at risk EG0012 events2 affected27 at risk EG0024 events3 affected28 at risk
Insomnia	Psychiatric disorders	MedDRA 26.1	Systematic Assessment	EG0004 events4 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0020 events0 affected28 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0021 events1 affected28 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0017 events7 affected27 at risk EG0024 events4 affected28 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events3 affected27 at risk EG0026 events6 affected28 at risk
Obstructive sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0022 events2 affected28 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected27 at risk EG0022 events2 affected28 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0002 events1 affected18 at risk EG0013 events2 affected27 at risk EG0021 events1 affected28 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0004 events2 affected18 at risk EG0018 events3 affected27 at risk EG0021 events1 affected28 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0013 events2 affected27 at risk EG0022 events2 affected28 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected27 at risk EG0020 events0 affected28 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0020 events0 affected28 at risk
Menopause	Social circumstances	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0020 events0 affected28 at risk
Haemorrhage	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected27 at risk EG0022 events2 affected28 at risk
Hot flush	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected27 at risk EG0021 events1 affected28 at risk
Hypertension	Vascular disorders	MedDRA 26.1	Systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected27 at risk EG0023 events3 affected28 at risk

Pharma Partner and Sponsor decided to terminate the study early based on the status of the drug program and findings from the interim efficacy analysis. The Interim Analysis will be updated here at a later date.

Certain Agreements

First MCP Posted Date

ID	Term
D000544	Alzheimer Disease
D003704	Dementia

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
C571128	gantenerumab

OG000-0.1382± 0.22606

OG001-0.3318± 0.40538

OG0020.1201± 0.15142

Eligible participants from gantenerumab treatment group in double-blind period entered OLE period to continue to receive gantenerumab up to 1500 mg SC infusion Q2W for 3 years.

OG0011.9524± 3.85326

OG0020.8889± 2.71006

OG0011.0000± 2.39046

OG0021.6154± 3.37980

OG0010.19329± 0.811715

OG0020.26572± 0.314147

OG001-0.02390± 0.860703

OG0020.21449± 0.281091

OG001-6.03388± 4.745042

OG002-1.19673± 2.262092

OG001-6.83542± 3.548298

OG002-1.48436± 2.746503

OG001351.02± 312.203

OG002257.12± 255.528

OG001609.45± 549.253

OG002402.20± 536.504

OG0010.03588± 0.025329

OG0020.00571± 0.010013

OG0010.05304± 0.037927

OG0020.01182± 0.022581

OG001-0.2373± 0.49333

OG002-0.2493± 0.48045

OG001-0.2738± 0.49439

OG002-0.1327± 0.31666