Average maximal increment (MΔ) of plasma anti-Aβ40 antibody signal (optical density [OD] in ELISA) in each subject with regard to Baseline visit.

The Modified Intent-to-treat (mITT) analysis set comprised all subjects in the ITT analysis set who had a Baseline- and at least 1 post-Baseline anti-Aβ40 antibody assessment (optical density [OD] in ELISA without pre-adsorption).

Analysis of the primary efficacy endpoint was carried out using the mITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

Number of withdrawn subjects due to treatment-emergent adverse events (TEAEs) during the whole study.

The safety analysis set consisted of all randomized subjects who received any amount of IMP. All safety analyses used the SAF analysis set. Subjects were analyzed according to the treatment received, regardless of the treatment assigned.

Clinically significant (CS) abnormalities in physical examination reported during the study.

The safety analysis set consisted of all randomized subjects who received any amount of IMP. All safety analyses used the SAF analysis set. Subjects were analyzed according to the treatment received, regardless of the treatment assigned.

Clinically significant (CS) abnormalities in neurological examination reported during the study.

The safety analysis set consisted of all randomized subjects who received any amount of IMP. All safety analyses used the SAF analysis set. Subjects were analyzed according to the treatment received, regardless of the treatment assigned.

Clinically significant (CS) abnormalities in hematology parameters reported during the study.

The safety analysis set consisted of all randomized subjects who received any amount of IMP. All safety analyses used the SAF analysis set. Subjects were analyzed according to the treatment received, regardless of the treatment assigned.

Clinically significant (CS) abnormalities in biochemistry parameters reported during the study.

The safety analysis set consisted of all randomized subjects who received any amount of IMP. All safety analyses used the SAF analysis set. Subjects were analyzed according to the treatment received, regardless of the treatment assigned.

Clinically significant (CS) abnormalities in coagulation parameters reported during the study.

The safety analysis set consisted of all randomized subjects who received any amount of IMP. All safety analyses used the SAF analysis set. Subjects were analyzed according to the treatment received, regardless of the treatment assigned.

The change in levels of anti-Aβ40 antibodies in cerebrospinal fluid (CSF) from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included the recorded outcome value as the dependent variable; treatment, protocol specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment.

assignment, regardless of the treatment received

The change in levels of anti-Aβ40 antibodies in plasma from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included the recorded outcome value as the dependent variable; treatment, protocol specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline age as covariates; and measures within-patient at each visit as a repeated measure. A compound symmetric variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of antibody-secreting cells from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included the recorded outcome value as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of anti-Aβ40 peptides in plasma (ABtest-IA) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of anti-Aβ42 peptides in plasma (ABtest-IA) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of anti-Aβ40 peptides in plasma (ABtest-MS) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. A compound symmetric variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of anti-Aβ42 peptides in plasma (ABtest-MS) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in amyloid-PET (a-PET) standard centiloid global cortical area (reference Pons) from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The percent change in brain volume from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The percent change in right and left hippocampal volume from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The percent change in ventricular volume from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of Aβ42 peptides in cerebrospinal fluid (CSF) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of Aβ40 peptides in cerebrospinal fluid (CSF) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in Aβ42/Aβ40 ratio in cerebrospinal fluid (CSF) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of total Tau in cerebrospinal fluid (CSF) from baseline to each applicable postbaseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of p-Tau 181 in cerebrospinal fluid (CSF) from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of neurofilament light in cerebrospinal fluid (CSF) from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in levels of neurogranin in cerebrospinal fluid (CSF) from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in MMSE score from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a MMRM and the ITT analysis set.

MMSE is an 11-question measure that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall, and language. MMSE score ranges: 0-30, with lower scores indicating worst cognition.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in CDR-SB score from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a MMRM and the ITT analysis set.

CDR-SB assesses 6 cognitive and functional domains: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, Personal Care. CDR-SB score ranges: 0-18. The higher scores mean a worst outcome.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in RBANS total score from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a MMRM and the ITT analysis set.

RBANS assesses 5 cognitive domains: Immediate Memory, Visuospatial/constructional, Language, Attention, Delayed Memory. Total score (range 40-160) sums the 5 domain scores. The higher scores mean a better outcome.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in ADCS-ADL MCI total score from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a MMRM and the ITT analysis set.

ADCS-ADL MCI is a 24-item scale that includes 6 basic activities of daily living (ADL) items and 16 instrumental ADL items that provide a total score: 0-78, with a lower score indicating greater severity.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

Change in TMT score from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a MMRM and the ITT analysis set.

TMT has 2 parts in which the patient connects 25 dots in order as quickly as possible. In TMT-A, targets are numbers 1-25; in TMT-B, targets are numbers 1-13 interleaved with letters A-L. Lower timings indicate better outcome.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

Change in IGE from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using MMRM and ITT analysis set.

IGE at baseline:1-Good general status;2-Slight deterioration;3-Moderate deterioration;4-Bad general status.

IGE after baseline:1-Marked improvement;2-Moderate improvement;3-Slight improvement;4-No change;5-Slight worsening;6-Moderate worsening;7-Marked worsening.

MMRM included IGE after baseline as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix is used. Following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly significantly associated with response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

Subjects with suicidal ideation or suicidal behavior since last visit.

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

Number of participants entered in each row differs from the overall number of participants because data from all participants were not available at each visit.

Change in EQ-5D-5L overall severity index from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using MMRM and ITT analysis set.

EQ-5D-5L has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression; rated: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

The change in EQ-5D-5L - VAS score from baseline to each applicable post-baseline efficacy visit (Part A) was analyzed using a Mixed-Model Repeated Measures (MMRM), and the ITT analysis set.

VAS records the patient's self-rated health on a vertical scale, ranging from 100 = 'Best imaginable health state' down to 0 = 'Worst imaginable health state'.

The MMRM included change from baseline in the efficacy parameter as the dependent variable; treatment, protocol-specified visits, treatment-by-visit interaction, and amyloid positivity as the fixed effects; baseline efficacy parameter and baseline age as covariates; and measures within-patient at each visit as a repeated measure. An unstructured variance-covariance matrix was used. The following factors may also have been included in the model: ApoE carrier status, baseline use of AD symptomatic medication and clinical subgroup - MCI or vmAD, if found to be significantly associated with the response measure (p < 0.15).

The Intent-to-treat (ITT) analysis set consisted of all subjects randomized who received any IMP. Analysis of all secondary efficacy endpoints was carried out using the ITT analysis set. Subjects were analyzed according to their randomized treatment assignment, regardless of the treatment received.

Average maximal increment (MΔ) of plasma anti-Aβ40 antibody signal (optical density [OD] in ELISA) in each subject with regard to Baseline visit.

Sensitivity analyses in the PP (Part A) analysis set.

The Per-Protocol analysis set comprised all subjects in the ITT analysis set who received all doses of the IMP (on V1, V4, V7, V10, V13 and V18 in Part A), attended the safety visit after Booster (V20 in Part A) and had no major protocol deviations that could have affected the efficacy analyses.