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Trial record 1 of 1 for:    NCT00960531
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A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00960531
Recruitment Status : Terminated
First Posted : August 17, 2009
Results First Posted : April 1, 2016
Last Update Posted : April 1, 2016
Sponsor:
Collaborator:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer Disease
Interventions Biological: ACC-001+ QS21 (3mcg)
Biological: ACC-001 (10 mcg) + QS-21
Biological: ACC-001+QS-21 (30mcg)
Enrollment 160
Recruitment Details Planned duration was approximately 2 years (including 18 months of treatment + 6 months of follow-up). Participants who completed lead-in B2571005 study through Week 78 had the option to stay in the lead-in study, or to roll-over into the extension protocol B2571008.
Pre-assignment Details  
Arm/Group Title ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 ACC 10 µg+QS-21 / ACC 10 µg+QS-21 ACC 10 µg / ACC 10 µg+QS-21 QS-21 / ACC 10 µg+QS-21 PBS / ACC 10 µg+QS-21 ACC 30 µg+QS-21 / ACC 30 µg+QS-21 ACC 30 µg / ACC 30 µg+QS-21 QS-21 / ACC 30 µg+QS-21 PBS / ACC 30 μg+QS-21
Hide Arm/Group Description 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. 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. 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. 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. 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. Participants received Phosphate buffered Saline (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. 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. 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. 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. 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.
Period Title: Overall Study
Started 21 [1] 6 [1] 41 [1] 25 [2] 5 [1] 9 [1] 27 [1] 6 [1] 16 [1] 4 [1]
Treated 21 6 41 24 5 9 27 6 16 4
Completed Treatment 12 5 15 17 3 7 4 3 2 4
Completed 11 [3] 5 [3] 15 [3] 17 [3] 3 [3] 6 [3] 3 [3] 2 [3] 2 [3] 3 [3]
Not Completed 10 1 26 8 2 3 24 4 14 1
Reason Not Completed
Lack of Efficacy             1             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             1             0             5             2             0             0             2             0             1             0
Caregiver Request             2             0             6             5             0             2             3             1             3             0
Investigator Request             0             0             1             0             0             0             0             0             0             0
Discontinuation of Study by Sponsor             0             0             0             0             0             0             0             1             0             0
Lost to Follow-up             0             0             1             0             0             0             1             0             0             0
Failed to Return             2             0             0             0             0             0             0             2             0             0
Adverse Event (AE)             2             0             0             0             0             1             2             0             2             0
Reason not Specified             2             1             13             1             2             0             16             0             8             1
[1]
Started=Randomized
[2]
Started=Randomized.
[3]
Completed study
Arm/Group Title ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 ACC 10 µg+QS-21 / ACC 10 µg+QS-21 ACC 10 µg / ACC 10 µg+QS-21 QS-21 / ACC 10 µg+QS-21 PBS / ACC 10 μg+QS-21 ACC 30 µg+QS-21 / ACC 30 µg+QS-21 ACC 30 µg / ACC 30 µg+QS-21 QS-21 / ACC 30 µg+QS-21 PBS / ACC 30 μg+QS-21 Total
Hide Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 21 6 41 25 5 9 27 6 16 4 160
Hide Baseline Analysis Population Description
160 participants were randomized and included in analysis. Of these, 1 participant was not treated: at screening, the site felt that Mini-Mental State Examination (MMSE) score was artificially low due to language issue. Hence, study enrollment was approved. Later, participant discontinued from study, which was recorded as major protocol deviation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 6 participants 41 participants 25 participants 5 participants 9 participants 27 participants 6 participants 16 participants 4 participants 160 participants
68.7  (6.94) 67.7  (9.52) 69.7  (9.29) 72.4  (9.12) 75.2  (8.23) 69.6  (7.94) 71.3  (9.20) 66.3  (9.42) 69.5  (6.95) 75.8  (7.89) 70.4  (8.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 6 participants 41 participants 25 participants 5 participants 9 participants 27 participants 6 participants 16 participants 4 participants 160 participants
Female
11
  52.4%
4
  66.7%
21
  51.2%
12
  48.0%
3
  60.0%
8
  88.9%
16
  59.3%
3
  50.0%
14
  87.5%
2
  50.0%
94
  58.8%
Male
10
  47.6%
2
  33.3%
20
  48.8%
13
  52.0%
2
  40.0%
1
  11.1%
11
  40.7%
3
  50.0%
2
  12.5%
2
  50.0%
66
  41.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 6 participants 41 participants 25 participants 5 participants 9 participants 27 participants 6 participants 16 participants 4 participants 160 participants
Asian 0 0 0 0 0 0 0 0 0 0 0
Black or African American 0 0 1 0 1 0 1 0 0 0 3
Other 1 0 0 0 0 0 0 0 0 0 1
White 20 6 40 25 4 9 26 6 16 4 156
MMSE Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 21 participants 6 participants 41 participants 25 participants 5 participants 9 participants 27 participants 6 participants 16 participants 4 participants 160 participants
16.7  (4.64) 18.3  (5.61) 18.4  (5.92) 19.6  (5.45) 21.8  (4.21) 20.0  (6.14) 18.7  (4.98) 20.5  (4.76) 19.1  (4.84) 20.0  (4.69) 18.8  (5.29)
[1]
Measure Description: The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.
MMSE Ranges   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 6 participants 41 participants 25 participants 5 participants 9 participants 27 participants 6 participants 16 participants 4 participants 160 participants
MMSE score >26 0 0 5 3 1 1 1 0 1 0 12
MMSE score 21-26 5 2 9 7 2 3 8 3 6 3 48
MMSE score 16-20 5 2 12 10 2 3 11 2 6 0 53
MMSE score 10-15 10 2 15 5 0 2 7 1 3 1 46
MMSE score <10 1 0 0 0 0 0 0 0 0 0 1
[1]
Measure Description: The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.
1.Primary Outcome
Title Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 Active / ACC 10 µg+QS-21 Control / ACC 10 µg+QS-21 Active / ACC 30 µg+QS-21 Control / ACC 30 μg+QS-21
Hide Arm/Group Description:
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.
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.
Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone 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.
Participants received 50 μg of QS-21 or 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.
Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone 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.
Participants received 50 μg of QS-21 or 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.
Overall Number of Participants Analyzed 21 6 65 14 33 20
Measure Type: Number
Unit of Measure: percentage of participants
Percentage of participants with AEs 100.0 100.0 93.8 92.9 78.8 90.0
Percentage of participants with SAEs 28.6 0.0 24.6 14.3 12.1 20.0
2.Other Pre-specified Outcome
Title 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
Hide Description IgM was not statistically analyzed.
Time Frame Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
IgM was not assessed.
Arm/Group Title ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 ACC 10 µg+QS-21 / ACC 10 µg+QS-21 ACC 10 µg / ACC 10 µg+QS-21 QS-21 / ACC 10 µg+QS-21 PBS / ACC 10 μg+QS-21 ACC 30 μg+QS-21 / ACC 30 μg+QS-21 ACC 30 μg / ACC 30 μg+QS-21 QS-21 / ACC 30 μg+QS-21 PBS / ACC 30 μg+QS-21
Hide Arm/Group Description:
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.
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.
Participants 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.
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.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Other Pre-specified Outcome
Title 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)
Hide Description IgG subtypes were not assessed
Time Frame Weeks 0, 4, 12, 24, 30, 36, 50, 56, 66, 76, 82, and 104
Hide Outcome Measure Data
Hide Analysis Population Description
IgG subtypes were not assessed.
Arm/Group Title ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 ACC 10 µg+QS-21 / ACC 10 µg+QS-21 ACC 10 µg / ACC 10 µg+QS-21 QS-21 / ACC 10 µg+QS-21 PBS / ACC 10 μg+QS-21 ACC 30 μg+QS-21 / ACC 30 μg+QS-21 ACC 30 μg / ACC 30 μg+QS-21 QS-21 / ACC 30 μg+QS-21 PBS / ACC 30 μg+QS-21
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Other Pre-specified Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 ACC 10 µg+QS-21 / ACC 10 µg+QS-21 ACC 10 µg / ACC 10 µg+QS-21 QS-21 / ACC 10 µg+QS-21 PBS / ACC 10 μg+QS-21 ACC 30 µg+QS-21 / ACC 30 µg+QS-21 ACC 30 µg / ACC 30 µg+QS-21 QS-21 / ACC 30 µg+QS-21 PBS / ACC 30 μg+QS-21
Hide Arm/Group Description:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Overall Number of Participants Analyzed 21 6 41 24 5 9 27 6 16 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/ml
Screening Lead-in (N:21,6,41,24,5,9,27,6,16,4)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
58.8
(41.6 to 83.3)
50.0 [1] 
(NA to NA)
Screening Extension (N:21,6,41,24,5,9,27,6,16,4)
836.5
(362.2 to 1932.3)
50.0 [1] 
(NA to NA)
1623.4
(1015.3 to 2595.7)
180.2
(76.4 to 425.3)
50.0 [1] 
(NA to NA)
50.0 [1] 
(NA to NA)
1718.3
(1101.2 to 2681.3)
424.2
(70.9 to 2539.4)
59.5
(41.0 to 86.3)
50.0 [1] 
(NA to NA)
Week 4 (N:21,6,41,24,5,9,27,5,16,4)
4523.7
(2070.2 to 9885.0)
50.0 [1] 
(NA to NA)
6219.3
(3853.2 to 10038.2)
517.9
(166.8 to 1607.6)
50.0 [1] 
(NA to NA)
60.6
(38.9 to 94.4)
8436.2
(5569.8 to 12778.0)
4223.0
(185.0 to 96408.3)
144.7
(67.9 to 308.0)
100.1
(11.0 to 912.6)
Week 12 (N:21,6,41,23,4,9,27,5,16,4)
2540.3
(1060.5 to 6084.8)
50.0 [1] 
(NA to NA)
4251.0
(2709.7 to 6669.2)
425.4
(137.0 to 1320.6)
50.0 [1] 
(NA to NA)
62.0
(37.8 to 101.7)
3604.3
(2009.6 to 6464.5)
761.6
(33.2 to 17472.9)
89.3
(43.7 to 182.5)
87.9
(14.6 to 529.8)
Week 24 (N:21,6,39,24,4,9,27,5,15,3)
1466.6
(607.2 to 3542.4)
50.0 [1] 
(NA to NA)
3058.1
(1887.1 to 4955.9)
280.3
(100.2 to 784.4)
50.0 [1] 
(NA to NA)
57.5
(41.7 to 79.2)
2146.4
(1309.0 to 3519.7)
541.1
(31.3 to 9362.1)
78.9
(42.6 to 146.1)
50.0 [1] 
(NA to NA)
Week 30 (N:18,6,38,20,4,6,24,5,14,3)
3780.6
(1941.7 to 7360.9)
477.1
(85.4 to 2664.5)
8682.0
(5670.1 to 13293.8)
1574.5
(568.2 to 4363.1)
552.2
(37.8 to 8075.8)
317.0
(27.5 to 3654.9)
12939.5
(8634.4 to 19391.2)
1374.9
(54.4 to 34722.9)
1889.4
(570.8 to 6254.5)
4360.1
(30.3 to 627361.8)
Week 36 (N:18,6,36,20,4,9,25,5,14,3)
2927.8
(1368.7 to 6262.8)
267.1
(53.6 to 1331.2)
5946.6
(3807.1 to 9288.6)
1029.4
(346.4 to 3059.1)
282.9
(43.5 to 1838.7)
428.0
(83.8 to 2186.8)
6228.9
(3794.3 to 10225.7)
706.7
(33.6 to 14852.3)
1018.5
(297.8 to 3483.6)
1164.2
(23.4 to 57811.5)
Week 50 (N:17,6,37,20,4,8,20,5,13,3)
1843.8
(776.1 to 4380.0)
141.3
(24.5 to 813.2)
3146.6
(1945.8 to 5088.4)
512.4
(176.5 to 1487.4)
169.6
(35.8 to 804.5)
333.6
(63.0 to 1767.0)
2439.0
(1369.5 to 4343.8)
527.7
(33.4 to 8348.8)
651.3
(189.9 to 2233.5)
401.4
(4.5 to 35461.1)
Week 56 (N:17,6,32,19,4,8,12,4,5,3)
4958.8
(2257.8 to 10891.0)
1441.4
(159.3 to 13045.1)
10412.4
(6365.4 to 17032.7)
4562.2
(2233.3 to 9319.8)
1720.0
(108.1 to 27356.9)
3451.0
(478.9 to 24871.3)
5241.2
(2459.3 to 11170.1)
2216.1
(38.0 to 129086.9)
578.3
(26.6 to 12559.5)
8033.5
(584.5 to 110404.7)
Week 66 (N:17,6,30,19,4,7,8,5,3,3)
2765.0
(1190.8 to 6420.3)
701.5
(86.0 to 5719.3)
6627.7
(3946.1 to 11131.5)
2049.2
(852.2 to 4927.5)
891.0
(32.6 to 24385.5)
1989.2
(152.1 to 26014.2)
4341.1
(1677.8 to 11232.1)
1315.8
(117.1 to 14780.6)
968.4
(43.0 to 21784.1)
5403.5
(171.1 to 170698.5)
Week 76 (N:14,5,23,19,4,7,5,5,3,3)
2802.1
(1334.8 to 5882.6)
842.5
(107.7 to 6592.3)
3373.8
(1763.5 to 6454.6)
1479.9
(575.1 to 3808.2)
628.5
(26.6 to 1478.7)
1235.3
(116.5 to 13096.6)
2030.7
(576.9 to 7147.4)
875.0
(94.7 to 8083.3)
494.1
(1.2 to 198416.2)
2042.8
(107.4 to 38841.8)
Week 82 (N:13,5,16,18,3,7,4,4,2,3)
6831.1
(3436.2 to 13579.9)
5104.3
(540.8 to 48180.8)
12261.1
(6635.8 to 22655.2)
5771.4
(3264.4 to 10203.5)
2768.5
(79.0 to 97040.9)
4779.6
(706.4 to 32339.3)
1902.0
(35.0 to 103340.7)
3736.1
(594.2 to 23491.3)
1617.1
(3.0 to 868223.9)
9922.5
(2059.8 to 47798.6)
Week 104 (N:12,5,14,17,2,5,5,2,2,3)
2951.6
(1259.3 to 6918.3)
1061.0
(77.8 to 14476.0)
6644.4
(2583.6 to 17088.1)
1565.2
(587.2 to 4172.5)
1128.4
(0.1 to 25253974.1)
832.4
(56.5 to 12268.2)
1447.6
(548.5 to 3820.9)
3654.5
(11.3 to 1181935.3)
321.9
(0.0 to 12636639.8)
1340.5
(421.5 to 4263.3)
[1]
below the level of detection, could not compute.
Time Frame Approximately 24 months, starting from Day 1, inclusive 18 months of dosing and 6 months of follow-up after the last dose.
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 Active / ACC 10 µg+QS-21 Control / ACC 10µg+QS-21 Active / ACC 30 µg+QS-21 Control / ACC 30 μg+QS-21
Hide Arm/Group Description 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. 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. Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone 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. Participants received 50 μg of QS-21 or 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. Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone 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. Participants received 50 μg of QS-21 or 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.
All-Cause Mortality
ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 Active / ACC 10 µg+QS-21 Control / ACC 10µg+QS-21 Active / ACC 30 µg+QS-21 Control / ACC 30 μg+QS-21
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 Active / ACC 10 µg+QS-21 Control / ACC 10µg+QS-21 Active / ACC 30 µg+QS-21 Control / ACC 30 μg+QS-21
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/21 (28.57%)   0/6 (0.00%)   16/65 (24.62%)   2/14 (14.29%)   4/33 (12.12%)   4/20 (20.00%) 
Blood and lymphatic system disorders             
Thrombocytopenia * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Cardiac disorders             
Angina pectoris * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Atrial fibrillation * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Bradyarrhythmia * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Bradycardia * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Cyanosis * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Mitral valve prolapse * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Ventricular tachycardia * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Eye disorders             
Cataract * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders             
Abdominal pain * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Diarrhoea * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Ileus * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
General disorders             
Chest pain * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Device dislocation * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Pelvic mass * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Hepatobiliary disorders             
Biliary colic * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications             
Fall * 1  1/21 (4.76%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Contusion * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Forearm fracture * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Hand fracture * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Hip fracture * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Lower limb fracture * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Rib fracture * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Road traffic accident * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Spinal compression fracture * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Investigations             
Liver function test abnormal * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Metabolism and nutrition disorders             
Dehydration * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Hypoglycaemia * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Gallbladder cancer metastatic * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Prostate cancer * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Nervous system disorders             
Syncope * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  1/14 (7.14%)  2/33 (6.06%)  1/20 (5.00%) 
Cerebral haemosiderin deposition * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Dementia Alzheimers type * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Dysarthria * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Epilepsy * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Ischaemic stroke * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Partial seizures * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Transient ischaemic attack * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Vasogenic cerebral oedema * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Psychiatric disorders             
Abnormal behaviour * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  1/33 (3.03%)  0/20 (0.00%) 
Agitated depression * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Agitation * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Suicidal ideation * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Renal and urinary disorders             
Calculus ureteric * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Renal failure acute * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Dyspnoea * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Pulmonary embolism * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Respiratory distress * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders             
Drug eruption * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Petechiae * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Skin exfoliation * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Skin fissures * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Skin haemorrhage * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Vascular disorders             
Deep vein thrombosis * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Peripheral vascular disorder * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Raynauds phenomenon * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACC 3 µg+QS-21 / ACC 3 µg+QS-21 QS-21 / ACC 3 µg+QS-21 Active / ACC 10 µg+QS-21 Control / ACC 10µg+QS-21 Active / ACC 30 µg+QS-21 Control / ACC 30 μg+QS-21
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/21 (90.48%)   6/6 (100.00%)   55/65 (84.62%)   13/14 (92.86%)   23/33 (69.70%)   17/20 (85.00%) 
Blood and lymphatic system disorders             
Anaemia * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Cardiac disorders             
Bradycardia * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Ear and labyrinth disorders             
Hearing impaired * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Eye disorders             
Cataract * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Glaucoma * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Heterophoria * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Retinal degeneration * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders             
Diarrhoea * 1  4/21 (19.05%)  1/6 (16.67%)  3/65 (4.62%)  1/14 (7.14%)  2/33 (6.06%)  0/20 (0.00%) 
Nausea * 1  1/21 (4.76%)  0/6 (0.00%)  3/65 (4.62%)  0/14 (0.00%)  0/33 (0.00%)  3/20 (15.00%) 
Vomiting * 1  3/21 (14.29%)  0/6 (0.00%)  1/65 (1.54%)  1/14 (7.14%)  1/33 (3.03%)  1/20 (5.00%) 
Constipation * 1  0/21 (0.00%)  0/6 (0.00%)  2/65 (3.08%)  0/14 (0.00%)  2/33 (6.06%)  2/20 (10.00%) 
Dental caries * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  1/33 (3.03%)  1/20 (5.00%) 
Faeces soft * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Inguinal hernia * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Periodontal disease * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
General disorders             
Injection site pain * 1  4/21 (19.05%)  0/6 (0.00%)  11/65 (16.92%)  2/14 (14.29%)  5/33 (15.15%)  6/20 (30.00%) 
Injection site erythema * 1  4/21 (19.05%)  0/6 (0.00%)  5/65 (7.69%)  1/14 (7.14%)  5/33 (15.15%)  4/20 (20.00%) 
Injection site swelling * 1  3/21 (14.29%)  0/6 (0.00%)  5/65 (7.69%)  0/14 (0.00%)  4/33 (12.12%)  1/20 (5.00%) 
Fatigue * 1  2/21 (9.52%)  1/6 (16.67%)  4/65 (6.15%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Injection site bruising * 1  1/21 (4.76%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  2/33 (6.06%)  1/20 (5.00%) 
Injection site haemorrhage * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  3/20 (15.00%) 
Injection site pruritus * 1  1/21 (4.76%)  0/6 (0.00%)  4/65 (6.15%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Injection site induration * 1  3/21 (14.29%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Injection site inflammation * 1  0/21 (0.00%)  0/6 (0.00%)  2/65 (3.08%)  0/14 (0.00%)  1/33 (3.03%)  1/20 (5.00%) 
Asthenia * 1  3/21 (14.29%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Induration * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Face oedema * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Inflammation * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Injection site hypersensitivity * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Immune system disorders             
Seasonal allergy * 1  2/21 (9.52%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Infections and infestations             
Urinary tract infection * 1  1/21 (4.76%)  4/6 (66.67%)  9/65 (13.85%)  1/14 (7.14%)  2/33 (6.06%)  1/20 (5.00%) 
Nasopharyngitis * 1  2/21 (9.52%)  1/6 (16.67%)  6/65 (9.23%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Upper respiratory tract infection * 1  1/21 (4.76%)  0/6 (0.00%)  3/65 (4.62%)  2/14 (14.29%)  1/33 (3.03%)  0/20 (0.00%) 
Bronchitis * 1  3/21 (14.29%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Gastrointestinal infection * 1  1/21 (4.76%)  1/6 (16.67%)  2/65 (3.08%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Rhinitis * 1  0/21 (0.00%)  0/6 (0.00%)  2/65 (3.08%)  0/14 (0.00%)  1/33 (3.03%)  1/20 (5.00%) 
Sinusitis * 1  1/21 (4.76%)  0/6 (0.00%)  1/65 (1.54%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Conjunctivitis * 1  0/21 (0.00%)  2/6 (33.33%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Onychomycosis * 1  1/21 (4.76%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Infected bites * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Influenza * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Localised infection * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Lyme disease * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Pneumonia * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Subcutaneous abscess * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Vulvovaginal mycotic infection * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Wound infection * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Injury, poisoning and procedural complications             
Fall * 1  4/21 (19.05%)  1/6 (16.67%)  7/65 (10.77%)  2/14 (14.29%)  2/33 (6.06%)  2/20 (10.00%) 
Contusion * 1  3/21 (14.29%)  1/6 (16.67%)  2/65 (3.08%)  1/14 (7.14%)  2/33 (6.06%)  1/20 (5.00%) 
Laceration * 1  0/21 (0.00%)  0/6 (0.00%)  3/65 (4.62%)  1/14 (7.14%)  2/33 (6.06%)  1/20 (5.00%) 
Limb injury * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Ankle fracture * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Corneal abrasion * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Eye contusion * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Hip fracture * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Periorbital contusion * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Investigations             
Weight decreased * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Bartonella test positive * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Urine output decreased * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Vitamin B1 decreased * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders             
Vitamin D deficiency * 1  0/21 (0.00%)  1/6 (16.67%)  3/65 (4.62%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Diabetes mellitus * 1  0/21 (0.00%)  0/6 (0.00%)  1/65 (1.54%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Glucose tolerance impaired * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders             
Back pain * 1  0/21 (0.00%)  0/6 (0.00%)  4/65 (6.15%)  1/14 (7.14%)  1/33 (3.03%)  2/20 (10.00%) 
Arthralgia * 1  0/21 (0.00%)  0/6 (0.00%)  4/65 (6.15%)  0/14 (0.00%)  1/33 (3.03%)  1/20 (5.00%) 
Muscle spasms * 1  0/21 (0.00%)  1/6 (16.67%)  4/65 (6.15%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Pain in extremity * 1  1/21 (4.76%)  0/6 (0.00%)  3/65 (4.62%)  1/14 (7.14%)  1/33 (3.03%)  0/20 (0.00%) 
Musculoskeletal pain * 1  1/21 (4.76%)  0/6 (0.00%)  1/65 (1.54%)  1/14 (7.14%)  1/33 (3.03%)  1/20 (5.00%) 
Neck pain * 1  0/21 (0.00%)  0/6 (0.00%)  4/65 (6.15%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Nervous system disorders             
Dizziness * 1  2/21 (9.52%)  0/6 (0.00%)  5/65 (7.69%)  2/14 (14.29%)  2/33 (6.06%)  2/20 (10.00%) 
Headache * 1  1/21 (4.76%)  0/6 (0.00%)  6/65 (9.23%)  1/14 (7.14%)  3/33 (9.09%)  1/20 (5.00%) 
Cognitive disorder * 1  1/21 (4.76%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  2/20 (10.00%) 
Myoclonus * 1  1/21 (4.76%)  1/6 (16.67%)  2/65 (3.08%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Syncope * 1  2/21 (9.52%)  0/6 (0.00%)  2/65 (3.08%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Dementia Alzheimers type * 1  0/21 (0.00%)  1/6 (16.67%)  1/65 (1.54%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Tremor * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  1/20 (5.00%) 
Balance disorder * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Hyperreflexia * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Hypoaesthesia * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Lethargy * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Psychiatric disorders             
Agitation * 1  3/21 (14.29%)  4/6 (66.67%)  5/65 (7.69%)  2/14 (14.29%)  3/33 (9.09%)  1/20 (5.00%) 
Depression * 1  3/21 (14.29%)  0/6 (0.00%)  3/65 (4.62%)  3/14 (21.43%)  2/33 (6.06%)  0/20 (0.00%) 
Anxiety * 1  2/21 (9.52%)  0/6 (0.00%)  4/65 (6.15%)  1/14 (7.14%)  1/33 (3.03%)  0/20 (0.00%) 
Aggression * 1  1/21 (4.76%)  1/6 (16.67%)  2/65 (3.08%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Confusional state * 1  1/21 (4.76%)  0/6 (0.00%)  4/65 (6.15%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Irritability * 1  0/21 (0.00%)  1/6 (16.67%)  1/65 (1.54%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Abnormal behaviour * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Delirium * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Delusional perception * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Nightmare * 1  0/21 (0.00%)  1/6 (16.67%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Renal and urinary disorders             
Haematuria * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  1/33 (3.03%)  0/20 (0.00%) 
Reproductive system and breast disorders             
Testicular pain * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough * 1  2/21 (9.52%)  1/6 (16.67%)  3/65 (4.62%)  0/14 (0.00%)  1/33 (3.03%)  0/20 (0.00%) 
Hiccups * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Oropharyngeal pain * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders             
Skin lesion * 1  2/21 (9.52%)  0/6 (0.00%)  1/65 (1.54%)  2/14 (14.29%)  1/33 (3.03%)  1/20 (5.00%) 
Pruritus * 1  1/21 (4.76%)  0/6 (0.00%)  3/65 (4.62%)  0/14 (0.00%)  1/33 (3.03%)  1/20 (5.00%) 
Rash * 1  1/21 (4.76%)  0/6 (0.00%)  4/65 (6.15%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Ecchymosis * 1  2/21 (9.52%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Erythema * 1  0/21 (0.00%)  0/6 (0.00%)  2/65 (3.08%)  1/14 (7.14%)  0/33 (0.00%)  0/20 (0.00%) 
Rosacea * 1  0/21 (0.00%)  0/6 (0.00%)  0/65 (0.00%)  1/14 (7.14%)  1/33 (3.03%)  0/20 (0.00%) 
Vascular disorders             
Hypertension * 1  1/21 (4.76%)  0/6 (0.00%)  3/65 (4.62%)  0/14 (0.00%)  2/33 (6.06%)  0/20 (0.00%) 
Hypotension * 1  0/21 (0.00%)  0/6 (0.00%)  5/65 (7.69%)  0/14 (0.00%)  0/33 (0.00%)  0/20 (0.00%) 
Haematoma * 1  1/21 (4.76%)  0/6 (0.00%)  1/65 (1.54%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
Haemorrhage * 1  1/21 (4.76%)  0/6 (0.00%)  0/65 (0.00%)  0/14 (0.00%)  0/33 (0.00%)  1/20 (5.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
In 2013 the sponsor decided that ACC-001 would not be further developed in mild to moderate Alzheimer's disease, study drug administration was discontinued, and remaining participants were followed for safety for up to 6 months after last injection.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00960531     History of Changes
Other Study ID Numbers: 3134K1-2205
B2571008 ( Other Identifier: Alias Study Number )
First Submitted: August 13, 2009
First Posted: August 17, 2009
Results First Submitted: December 18, 2014
Results First Posted: April 1, 2016
Last Update Posted: April 1, 2016