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

A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00955409

Enrollment

160

Registered

2009-08-10

Start date

2009-11-05

Completion date

2013-12-17

Last updated

2021-03-25

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

Conditions

Alzheimer Disease

Brief summary

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.

Interventions

BIOLOGICALACC-001(3µg) + QS21

Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

BIOLOGICALACC-001(10µg) + QS21

Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

BIOLOGICALACC-001(30µg) + QS21

Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the

Exclusion criteria

* Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	24 months	An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Other

Measure	Time frame	Description
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	IGM was not statistically analyzed.
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	IgG subtypes were not assessed
Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.

Countries

France, Germany, Spain

Participant flow

Recruitment details

Planned duration was approximately 2 years (including 18 months of treatment + 6 months of follow-up). Participants who completed the lead-in 3134K1-200-EU (B2571004) study through Week 78 (Week 104 for Cohort 1 and 2) had the option to stay in the lead-in study or to roll-over into the extension protocol 3134K1-2203-EU (B2571007).

Pre-assignment details

The Basic Results disclose pooled data from the extension studies 3134K1-2203-EU (B2571007) and 3134K1-2205-US (B2571008).

Participants by arm

Arm	Count
ACC 3 µg+QS-21 / ACC 3 µg+QS-21 Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	21
QS-21 / ACC 3 µg+QS-21 Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	6
ACC 10 µg+QS-21 / ACC 10 µg+QS-21 Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	41
ACC 10 µg / ACC 10 µg+QS-21 Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	25
QS-21 / ACC 10 µg+QS-21 Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	5
PBS / ACC 10 μg+QS-21 Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	9
ACC 30 µg+QS-21 / ACC 30 µg+QS-21 Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	27
ACC 30 µg / ACC 30 µg+QS-21 Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	6
QS-21 / ACC 30 µg+QS-21 Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	16
PBS / ACC 30 μg+QS-21 Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.	4
Total	160

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005	FG006	FG007	FG008	FG009
Overall Study	Adverse Event (AE)	2	0	0	0	0	1	2	0	2	0
Overall Study	Caregiver Request	2	0	6	5	0	2	3	1	3	0
Overall Study	Discontinuation of Study by Sponsor	0	0	0	0	0	0	0	1	0	0
Overall Study	Failed to Return	2	0	0	0	0	0	0	2	0	0
Overall Study	Investigator Request	0	0	1	0	0	0	0	0	0	0
Overall Study	Lack of Efficacy	1	0	0	0	0	0	0	0	0	0
Overall Study	Lost to Follow-up	0	0	1	0	0	0	1	0	0	0
Overall Study	Reason not Specified	2	1	13	1	2	0	16	0	8	1
Overall Study	Withdrawal by Subject	1	0	5	2	0	0	2	0	1	0

Baseline characteristics

Characteristic	QS-21 / ACC 3 µg+QS-21	Total	PBS / ACC 30 μg+QS-21	QS-21 / ACC 30 µg+QS-21	ACC 30 µg / ACC 30 µg+QS-21	ACC 30 µg+QS-21 / ACC 30 µg+QS-21	PBS / ACC 10 μg+QS-21	QS-21 / ACC 10 µg+QS-21	ACC 10 µg / ACC 10 µg+QS-21	ACC 10 µg+QS-21 / ACC 10 µg+QS-21	ACC 3 µg+QS-21 / ACC 3 µg+QS-21
Age, Continuous	67.7 years STANDARD_DEVIATION 9.52	70.4 years STANDARD_DEVIATION 8.61	75.8 years STANDARD_DEVIATION 7.89	69.5 years STANDARD_DEVIATION 6.95	66.3 years STANDARD_DEVIATION 9.42	71.3 years STANDARD_DEVIATION 9.2	69.6 years STANDARD_DEVIATION 7.94	75.2 years STANDARD_DEVIATION 8.23	72.4 years STANDARD_DEVIATION 9.12	69.7 years STANDARD_DEVIATION 9.29	68.7 years STANDARD_DEVIATION 6.94
MMSE Ranges MMSE score <10	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
MMSE Ranges MMSE score 10-15	2 Participants	46 Participants	1 Participants	3 Participants	1 Participants	7 Participants	2 Participants	0 Participants	5 Participants	15 Participants	10 Participants
MMSE Ranges MMSE score 16-20	2 Participants	53 Participants	0 Participants	6 Participants	2 Participants	11 Participants	3 Participants	2 Participants	10 Participants	12 Participants	5 Participants
MMSE Ranges MMSE score 21-26	2 Participants	48 Participants	3 Participants	6 Participants	3 Participants	8 Participants	3 Participants	2 Participants	7 Participants	9 Participants	5 Participants
MMSE Ranges MMSE score >26	0 Participants	12 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	3 Participants	5 Participants	0 Participants
MMSE Score	18.3 score STANDARD_DEVIATION 5.61	18.8 score STANDARD_DEVIATION 5.29	20.0 score STANDARD_DEVIATION 4.69	19.1 score STANDARD_DEVIATION 4.84	20.5 score STANDARD_DEVIATION 4.76	18.7 score STANDARD_DEVIATION 4.98	20.0 score STANDARD_DEVIATION 6.14	21.8 score STANDARD_DEVIATION 4.21	19.6 score STANDARD_DEVIATION 5.45	18.4 score STANDARD_DEVIATION 5.92	16.7 score STANDARD_DEVIATION 4.64
Race/Ethnicity, Customized Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Black or African American	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Race/Ethnicity, Customized Other	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White	6 Participants	156 Participants	4 Participants	16 Participants	6 Participants	26 Participants	9 Participants	4 Participants	25 Participants	40 Participants	20 Participants
Sex: Female, Male Female	4 Participants	94 Participants	2 Participants	14 Participants	3 Participants	16 Participants	8 Participants	3 Participants	12 Participants	21 Participants	11 Participants
Sex: Female, Male Male	2 Participants	66 Participants	2 Participants	2 Participants	3 Participants	11 Participants	1 Participants	2 Participants	13 Participants	20 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	19 / 21	6 / 6	55 / 65	13 / 14	23 / 33	17 / 20
serious Total, serious adverse events	6 / 21	0 / 6	16 / 65	2 / 14	4 / 33	4 / 20

Outcome results

Primary

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Time frame: 24 months

Population: All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.

Arm	Measure	Group	Value (NUMBER)
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with AEs	100.0 percentage of participants
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with SAEs	28.6 percentage of participants
QS-21 / ACC 3 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with SAEs	0 percentage of participants
QS-21 / ACC 3 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with AEs	100.0 percentage of participants
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with AEs	93.8 percentage of participants
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with SAEs	24.6 percentage of participants
ACC 10 µg / ACC 10 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with AEs	92.9 percentage of participants
ACC 10 µg / ACC 10 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with SAEs	14.3 percentage of participants
QS-21 / ACC 10 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with AEs	78.8 percentage of participants
QS-21 / ACC 10 µg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with SAEs	12.1 percentage of participants
PBS / ACC 10 μg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with AEs	90.0 percentage of participants
PBS / ACC 10 μg+QS-21	Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)	Percentage of participants with SAEs	20.0 percentage of participants

Other Pre-specified

Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)

IgG subtypes were not assessed

Time frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Other Pre-specified

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.

Time frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Population: The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	6831.1 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	1843.8 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	2540.3 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	836.5 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	4523.7 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	2951.6 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	2765.0 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	1466.6 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	3780.6 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	2802.1 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	2927.8 U/ml
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	4958.8 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	842.5 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	1441.4 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	50.0 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	701.5 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	141.3 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	50.0 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	267.1 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	50.0 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	477.1 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	1061.0 U/ml
QS-21 / ACC 3 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	5104.3 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	6644.4 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	3146.6 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	6219.3 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	4251.0 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	12261.1 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	3373.8 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	3058.1 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	1623.4 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	6627.7 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	8682.0 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	10412.4 U/ml
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	5946.6 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	1565.2 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	2049.2 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	5771.4 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	1029.4 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	512.4 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	280.3 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	425.4 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	180.2 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	1574.5 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	517.9 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	1479.9 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	4562.2 U/ml
ACC 10 µg / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	50.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	552.2 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	891.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	282.9 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	50.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	1128.4 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	50.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	1720.0 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	169.6 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	628.5 U/ml
QS-21 / ACC 10 µg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	2768.5 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	428.0 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	60.6 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	62.0 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	57.5 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	317.0 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	333.6 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	3451.0 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	1989.2 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	1235.3 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	4779.6 U/ml
PBS / ACC 10 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	832.4 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	2030.7 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	2146.4 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	12939.5 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	5241.2 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	1447.6 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	4341.1 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	1718.3 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	6228.9 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	8436.2 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	2439.0 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	3604.3 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	1902.0 U/ml
ACC 30 μg+QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	3654.5 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	875.0 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	706.7 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	424.2 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	2216.1 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	541.1 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	4223.0 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	527.7 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	1315.8 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	1374.9 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	3736.1 U/ml
ACC 30 μg / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	761.6 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	59.5 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	1889.4 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	578.3 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	78.9 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	89.3 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	968.4 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	494.1 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	651.3 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	144.7 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	321.9 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	1617.1 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	1018.5 U/ml
QS-21 / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	58.8 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 66 (N:17,6,30,19,4,7,8,5,3,3)	5403.5 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 50 (N:17,6,37,20,4,8,20,5,13,3)	401.4 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 82 (N:13,5,16,18,3,7,4,4,2,3)	9922.5 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 12 (N:21,6,41,23,4,9,27,5,16,4)	87.9 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 56 (N:17,6,32,19,4,8,12,4,5,3)	8033.5 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Extension (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)	50.0 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 36 (N:18,6,36,20,4,9,25,5,14,3)	1164.2 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 76 (N:14,5,23,19,4,7,5,5,3,3)	2042.8 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 24 (N:21,6,39,24,4,9,27,5,15,3)	50.0 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 30 (N:18,6,38,20,4,6,24,5,14,3)	4360.1 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 104 (N:12,5,14,17,2,5,5,2,2,3)	1340.5 U/ml
PBS / ACC 30 μg+QS-21	Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104	Week 4 (N:21,6,41,24,5,9,27,5,16,4)	100.1 U/ml

Other Pre-specified

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

IGM was not statistically analyzed.

Time frame: Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

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

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Other

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104 if Applicable)

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104

GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104