Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.

Time frame: Baseline of the preceding studies through 24 months of this study

Population: The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.

Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.

Time frame: Baseline up to 24 months

Population: The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.

Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)

Time frame: Baseline up to 24 months

Population: The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.

Geometric mean of anti-a-beta IgG titer from baseline of the preceding studies through the end of this study

Time frame: Baseline of preceding studies to month 24 of this study (Week 210)

Population: The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection.

Geotmetric mean of anti-a-beta IgM titer from baseline of the preceding studies through the end of this study

Time frame: Baseline of preceding studies to month 24 of this study (Week 210)

Population: The immunogenicity analysis population consisted of those in the safety analysis population who had baseline immunogenicity evaluation in the preceding study and at least one immunogenicity evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the IgM data were not summarized.

The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11, with higher scores indicating a greater degree of impairment. The total score ranges from 0 (no impairment) to 70 (worst impairment).

Time frame: Baseline up to 24 Months

Population: The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the ADAS-Cog scores were not summarized.

The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.

Time frame: Baseline up to 24 Months

Population: The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the DAD scores were not summarized.

The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points, and any score equal to or lower than 26 points indicates cognitive impairment.

Time frame: Baseline up to 24 Months

Population: The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the MMSE scores were not summarized.

The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\_visit - y\_base)/SD\_base, where y\_visit is a value at a particular time point and y\_base is the average test score, and SD\_base is the SD based on all participants' observed baseline scores in the study.

Time frame: Baseline up to 24 Months

Population: The efficacy analysis population was all of the participants who received at least one injection in this study and had baseline efficacy evaluation in the preceding study and at least one efficacy evaluation post injection. Since the study was early terminated and the data could not be obtained as planned, the NTB scores were not summarized.