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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00959192
Recruitment Status : Completed
First Posted : August 14, 2009
Results First Posted : January 1, 2016
Last Update Posted : January 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's Disease
Interventions Biological: ACC-001
Other: QS-21
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Period Title: Overall Study
Started 6 9 9 8
Completed 4 8 6 7
Not Completed 2 1 3 1
Reason Not Completed
Adverse Event             1             1             1             0
Investigator Request             1             0             0             0
Caregiver Request             0             0             2             1
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21 Total
Hide Arm/Group Description A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 Total of all reporting groups
Overall Number of Baseline Participants 6 9 9 8 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 9 participants 9 participants 8 participants 32 participants
72.50  (8.73) 68.00  (10.34) 74.33  (6.69) 64.75  (7.15) 69.81  (8.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 9 participants 9 participants 8 participants 32 participants
Female
6
 100.0%
6
  66.7%
6
  66.7%
7
  87.5%
25
  78.1%
Male
0
   0.0%
3
  33.3%
3
  33.3%
1
  12.5%
7
  21.9%
1.Primary Outcome
Title Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Hide Description Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Measure Type: Number
Unit of Measure: Participants
Mild 4 7 7 5
Moderate 2 1 1 2
Severe 0 0 1 0
2.Primary Outcome
Title Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Hide Description Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Measure Type: Number
Unit of Measure: Participants
Abnormal - inconsistent with AD 1 0 2 0
Abnormal - consistent with AD 6 9 9 8
3.Primary Outcome
Title Number of Participants With Abnormalities in Neurological Examination
Hide Description Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Measure Type: Number
Unit of Measure: Participants
Total 1 1 0 0
Mental Status 0 0 0 0
Speech 0 0 0 0
Cranial Nerves 0 0 0 0
Visual Field 0 0 0 0
Sensory 1 0 0 0
Motor 0 0 0 0
Coordination 0 0 0 0
Gate 0 0 0 0
Primitive reflexes 0 0 0 0
Tendon reflexes 0 0 0 0
Romberg 0 1 0 0
4.Secondary Outcome
Title Anti-a-beta IgG Titer at Specified Visits
Hide Description Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: Units/mL
Pre-study (n=6,9,9,8)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
50.0
(50.0 to 50.0)
Week 2 (n=6,9,9,8)
62.2
(35.5 to 109.3)
65.0
(35.5 to 118.9)
67.0
(34.1 to 131.8)
50.0
(50.0 to 50.0)
Week 4 (n=6,9,9,8)
107.9
(30.3 to 384.4)
94.2
(40.1 to 221.1)
79.0
(27.5 to 227.1)
50.0
(50.0 to 50.0)
Week 6 (n=6,9,9,8)
2106.5
(141.7 to 31312.7)
4793.2
(1261.0 to 18220.0)
5702.6
(1181.1 to 17288.0)
50.0
(50.0 to 50.0)
Week 8 (n=6,9,9,8)
1143.3
(108.0 to 12104.3)
2331.4
(512.2 to 10612.3)
3423.9
(1182.1 to 9917.0)
50.0
(50.0 to 50.0)
Week 10 (n=6,9,9,8)
979.2
(96.8 to 9903.1)
1674.9
(369.5 to 7592.9)
2012.4
(643.4 to 6294.9)
50.0
(50.0 to 50.0)
Week 14 (n=6,9,9,8)
6088.4
(714.5 to 51878.2)
6286.2
(3923.5 to 10071.6)
9983.5
(2820.9 to 35333.3)
50.0
(50.0 to 50.0)
Week 16 (n=6,9,9,8)
3860.4
(342.5 to 43507.1)
4170.4
(2641.8 to 6583.4)
9228.0
(2930.5 to 29058.2)
50.0
(50.0 to 50.0)
Week 24 (n=6,9,9,8)
1151.5
(165.8 to 7998.4)
1455.0
(936.2 to 2261.1)
3903.1
(1151.8 to 13226.8)
50.0
(50.0 to 50.0)
Week 28 (n=6,9,7,8)
8216.5
(1550.5 to 43541.2)
8929.3
(4466.9 to 17849.8)
7429.5
(3925.7 to 14060.5)
50.0
(50.0 to 50.0)
Week 30 (n=6,9,7,8)
7218.7
(1438.9 to 36213.5)
7017.4
(3510.7 to 14026.7)
6162.2
(3062.2 to 12400.6)
50.0
(50.0 to 50.0)
Week 40 (n=5,9,8,8)
3136.4
(651.2 to 15106.7)
2706.5
(1358.1 to 5393.9)
3615.5
(1145.5 to 11411.2)
50.0
(50.0 to 50.0)
Week 50 (n=6,8,7,8)
1854.5
(558.3 to 6159.4)
1255.8
(656.3 to 2402.9)
1261.4
(699.2 to 2275.9)
50.0
(50.0 to 50.0)
Week 54 (n=5,8,7,7)
2873.6
(264.8 to 31178.1)
9636.4
(4558.5 to 20370.7)
8604.6
(4030.7 to 18368.8)
50.0
(50.0 to 50.0)
Week 56 (n=4,8,7,7)
11006.2
(1617.8 to 74878.3)
7582.4
(3143.9 to 18286.8)
6201.5
(2921.4 to 13164.5)
50.0
(50.0 to 50.0)
Week 66 (n=4,8,7,7)
7407.9
(1127.0 to 48693.5)
3942.5
(1539.4 to 10096.9)
2452.5
(1442.5 to 4169.7)
50.0
(50.0 to 50.0)
Week 78 (n=4,8,6,7)
5108.6
(1013.9 to 25739.1)
2465.3
(961.9 to 6318.5)
1316.3
(645.0 to 2686.1)
50.0
(50.0 to 50.0)
Week 91 (n=0,1,1,0)
NA [1] 
(NA to NA)
546.0 [2] 
(NA to NA)
389.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
Week 104 (n=0,1,1,0)
NA [1] 
(NA to NA)
414.0 [2] 
(NA to NA)
285.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data were not analyzed as no participants were evaluable for the particular week.
[2]
95% confidence interval was not estimable since only one participant was evaluable.
5.Secondary Outcome
Title Anti-a-beta IgM Titer at Specified Visits
Hide Description Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Geometric Mean (95% Confidence Interval)
Unit of Measure: Units/mL
Pre-study (n=6,9,9,8)
30.9
(17.9 to 53.6)
28.2
(21.3 to 37.4)
25.0
(25.0 to 25.0)
41.5
(21.8 to 78.8)
Week 2 (n=6,9,9,8)
77.1
(17.1 to 347.0)
92.0
(31.7 to 266.6)
53.5
(22.5 to 127.6)
42.4
(21.6 to 83.3)
Week 4 (n=6,9,9,8)
108.5
(19.4 to 605.6)
141.5
(41.6 to 481.5)
108.5
(41.0 to 286.9)
43.7
(21.6 to 88.3)
Week 6 (n=6,9,9,8)
953.2
(95.7 to 9493.1)
2988.4
(879.2 to 10157.9)
2381.4
(662.7 to 8556.9)
43.0
(21.6 to 85.9)
Week 8 (n=6,9,9,8)
848.6
(85.6 to 8414.6)
2940.1
(812.5 to 10639.6)
2776.2
(622.2 to 12386.2)
46.9
(23.7 to 92.9)
Week 10 (n=6,9,9,8)
850.8
(147.5 to 4907.8)
2432.1
(661.4 to 8943.5)
2323.9
(482.5 to 11192.7)
36.1
(19.1 to 68.2)
Week 14 (n=6,9,9,8)
1487.6
(288.1 to 7682.0)
2231.0
(728.6 to 6831.2)
4438.5
(1000.5 to 19689.6)
37.6
(19.6 to 72.3)
Week 16 (n=6,9,9,8)
1503.2
(254.5 to 8880.8)
2484.8
(797.6 to 7740.9)
4590.6
(1041.7 to 20230.3)
40.5
(18.4 to 89.5)
Week 24 (n=6,9,9,8)
898.5
(222.1 to 3634.1)
1421.8
(442.7 to 4565.8)
2396.4
(643.2 to 8928.8)
40.1
(18.4 to 87.1)
Week 28 (n=6,9,7,8)
885.9
(240.0 to 3270.2)
3395.8
(1356.5 to 8500.9)
3592.8
(628.7 to 20531.3)
42.1
(21.3 to 83.3)
Week 30 (n=6,9,7,8)
859.5
(273.2 to 2704.0)
3729.9
(1286.6 to 10812.9)
2956.7
(636.6 to 13732.9)
38.9
(19.4 to 78.2)
Week 40 (n=5,9,8,8)
449.0
(110.4 to 1825.7)
2480.5
(760.2 to 8093.8)
1967.3
(421.5 to 9183.1)
37.8
(19.2 to 74.4)
Week 50 (n=6,8,7,8)
354.2
(75.6 to 1659.4)
1330.0
(388.5 to 4553.3)
1326.8
(233.3 to 7546.2)
39.9
(17.9 to 88.8)
Week 54 (n=5,8,7,7)
680.7
(120.0 to 3861.3)
2605.4
(862.1 to 7874.2)
3017.0
(678.8 to 13408.9)
48.3
(19.2 to 121.1)
Week 56 (n=4,8,7,7)
1768.3
(342.4 to 9132.4)
2570.6
(794.2 to 8320.4)
3051.9
(618.2 to 15066.0)
40.5
(16.4 to 100.0)
Week 66 (n=4,8,7,7)
1213.0
(244.1 to 6027.2)
1872.7
(523.3 to 6701.7)
1825.1
(346.2 to 9621.6)
46.0
(20.2 to 104.4)
Week 78 (n=4,8,6,7)
952.8
(251.0 to 3617.1)
1650.3
(491.4 to 5542.5)
844.9
(155.4 to 4594.7)
48.3
(19.0 to 122.8)
Week 91 (n=0,1,1,0)
NA [1] 
(NA to NA)
219.0 [2] 
(NA to NA)
351.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
Week 104 (n=0,1,1,0)
NA [1] 
(NA to NA)
154.0 [2] 
(NA to NA)
258.0 [2] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Data were not analyzed as no participants were evaluable for the particular week.
[2]
95% confidence interval was not estimable since only one participant was evaluable.
6.Other Pre-specified Outcome
Title The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
Hide Description The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (n=6,9,9,8) 0.06  (5.20) 0.52  (4.39) 2.93  (4.10) -0.25  (3.30)
Week 26 (n=6,9,9,8) 0.39  (4.38) -0.41  (5.41) 3.56  (6.74) -0.63  (5.76)
Week 52 (n=5,9,7,8) 1.87  (8.32) 0.15  (4.82) 5.05  (6.68) 1.04  (7.01)
Week 78 (n=4,8,6,7) 0.17  (3.50) 3.40  (7.08) 5.39  (3.66) 2.33  (7.78)
Week 104 (n=0,1,1,0) NA [1]   (NA) -4.33 [2]   (NA) 8.33 [2]   (NA) NA [1]   (NA)
[1]
Data were not analyzed as no participants were evaluable for the particular week.
[2]
Standard deviation was not estimable since only one participant was evaluable.
7.Other Pre-specified Outcome
Title The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
Hide Description

The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living.

A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.

Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 8 8
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 12 (n=5,9,7,8) -4.7  (9.7) 0.7  (2.6) 1.5  (5.1) 1.7  (6.4)
Week 26 (n=6,9,8,8) -10.1  (14.5) -0.2  (11.9) -4.4  (28.6) -0.6  (6.5)
Week 52 (n=5,8,6,8) -11.2  (20.9) -3.4  (10.7) -1.8  (5.1) -3.1  (9.0)
Week 78 (n=4,8,5,6) -0.6  (3.1) -5.4  (7.7) 0.5  (6.9) 3.5  (3.2)
Week 104 (n=0,1,1,0) NA [1]   (NA) 0 [2]   (NA) 12.8 [2]   (NA) NA [1]   (NA)
[1]
Data were not analyzed as no participants were evaluable for the particular week.
[2]
Standard deviation was not estimable since only one participant was evaluable.
8.Other Pre-specified Outcome
Title The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
Hide Description The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y_visit – y_base)/SD_base, where y_visit is a value at a particular time point and y_base is the average test score, and SD_base is the SD based on all participants’ observed baseline scores in the study.
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Mean (Standard Deviation)
Unit of Measure: Z-score
Week 12 (n=6,9,8,8) 0.023  (0.416) 0.275  (0.280) -0.028  (0.282) 0.227  (0.107)
Week 26 (n=6,9,9,8) 0.114  (0.423) 0.254  (0.353) -0.081  (0.530) 0.222  (0.308)
Week 52 (n=5,9,7,8) 0.081  (0.288) 0.211  (0.285) -0.109  (0.263) 0.213  (0.416)
Week 78 (n=4,8,6,7) -0.088  (0.334) -0.037  (0.494) -0.120  (0.442) 0.246  (0.336)
Week 104 (n=0,1,1,0) NA [1]   (NA) 0.514 [2]   (NA) -0.559 [2]   (NA) NA [1]   (NA)
[1]
Data were not analyzed as no participants were evaluable for the particular week.
[2]
Standard deviation was not estimable since only one participant was evaluable.
9.Other Pre-specified Outcome
Title The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
Hide Description The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.
Time Frame Baseline up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description:
A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
Overall Number of Participants Analyzed 6 9 9 8
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 (n=6,9,9,8) 1.7  (1.5) 1.3  (1.7) 1.6  (2.7) 0.4  (2.3)
Week 8 (n=6,9,9,8) 2.2  (3.1) 0.9  (3.2) 1.3  (1.7) 0.9  (2.6)
Week 12 (n=6,9,9,8) 0.8  (2.8) 1.1  (2.7) 1.1  (2.0) 1.4  (2.7)
Week 16 (n=6,9,9,8) 1.5  (3.4) 1.3  (2.3) 2.9  (2.5) 0.4  (1.8)
Week 26 (n=6,9,8,8) 0.3  (3.8) 0.1  (2.6) 1.0  (2.8) -0.1  (1.6)
Week 30 (n=6,9,8,8) 0.3  (3.7) 1.2  (2.4) 1.6  (2.4) 0.3  (3.3)
Week 40 (n=4,9,7,8) 2.3  (2.2) 0.8  (3.5) 0.7  (2.0) 0.5  (3.2)
Week 52 (n=5,8,7,7) 0.4  (4.5) 1.0  (3.8) 1.1  (2.1) 0.6  (2.5)
Week 78 (n=4,8,6,7) 1.8  (2.5) -1.4  (3.9) -0.3  (1.2) 0.0  (3.2)
Week 104 (n=0,1,1,0) NA [1]   (NA) -2.0 [2]   (NA) -1.0 [2]   (NA) NA [1]   (NA)
[1]
Data were not analyzed as no participants were evaluable for the particular week.
[2]
Standard deviation was not estimable since only one participant was evaluable.
Time Frame [Not Specified]
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 subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Hide Arm/Group Description A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
All-Cause Mortality
ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/9 (0.00%)   0/9 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ACC-001 3 Micrograms + QS-21 ACC-001 10 Micrograms + QS-21 ACC-001 30 Micrograms + QS-21 QS-21
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   8/9 (88.89%)   9/9 (100.00%)   7/8 (87.50%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Ear and labyrinth disorders         
Vestibular disorder  1  0/6 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders         
Constipation  1  1/6 (16.67%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Dental caries  1  0/6 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Gastric ulcer  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Nausea  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Vomiting  1  1/6 (16.67%)  1/9 (11.11%)  1/9 (11.11%)  0/8 (0.00%) 
General disorders         
Injection site erythema  1  2/6 (33.33%)  1/9 (11.11%)  1/9 (11.11%)  0/8 (0.00%) 
Injection site haematoma  1  0/6 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Injection site pain  1  1/6 (16.67%)  0/9 (0.00%)  1/9 (11.11%)  2/8 (25.00%) 
Injection site swelling  1  3/6 (50.00%)  1/9 (11.11%)  1/9 (11.11%)  0/8 (0.00%) 
Pyrexia  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Immune system disorders         
Food allergy  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Infections and infestations         
Cellulitis  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Enterocolitis infectious  1  0/6 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Folliculitis  1  0/6 (0.00%)  1/9 (11.11%)  1/9 (11.11%)  0/8 (0.00%) 
Gastroenteritis viral  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Gingivitis  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Herpes zoster  1  0/6 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Influenza  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Nasopharyngitis  1  2/6 (33.33%)  4/9 (44.44%)  3/9 (33.33%)  3/8 (37.50%) 
Periodontitis  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Pharyngitis  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Injury, poisoning and procedural complications         
Chillblains  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Contusion  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Fall  1  1/6 (16.67%)  2/9 (22.22%)  0/9 (0.00%)  1/8 (12.50%) 
Head injury  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Ligament sprain  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Spinal compression fracture  1  1/6 (16.67%)  1/9 (11.11%)  0/9 (0.00%)  1/8 (12.50%) 
Subcutaneous haematoma  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Subdural haematoma  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Wrist fracture  1  0/6 (0.00%)  0/9 (0.00%)  0/9 (0.00%)  1/8 (12.50%) 
Investigations         
Aspartate aminotransferase increased  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Blood alkaline phosphatase increased  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Blood cholesterol increased  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Blood creatine phosphokinase increased  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Blood pressure decreased  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Electrocardiogram QT prolonged  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Gamma-glutamyltransferase increased  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Positive Rombergism  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Protein urine present  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/6 (16.67%)  0/9 (0.00%)  1/9 (11.11%)  1/8 (12.50%) 
Dehydration  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Lipid metabolism disorder  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal chest pain  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Osteoporosis  1  1/6 (16.67%)  1/9 (11.11%)  0/9 (0.00%)  1/8 (12.50%) 
Spinal osteoarthritis  1  0/6 (0.00%)  2/9 (22.22%)  1/9 (11.11%)  0/8 (0.00%) 
Nervous system disorders         
Cerebral infarction  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Cerebral microhaemorrhage  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  1/8 (12.50%) 
Dizziness  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Dyskinesia  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Haemorrhagic cerebral infarction  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Headache  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Hypoaesthesia  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Intercostal neuralgia  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Loss of consciousness  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Meralgia paraesthetica  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Psychiatric disorders         
Agitation  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Anxiety  1  0/6 (0.00%)  0/9 (0.00%)  1/9 (11.11%)  0/8 (0.00%) 
Depression  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders         
Dermatitis  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Haemorrhage subcutaneous  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Rash pruritic  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Urticaria  1  1/6 (16.67%)  0/9 (0.00%)  0/9 (0.00%)  0/8 (0.00%) 
Vascular disorders         
Hypertension  1  0/6 (0.00%)  1/9 (11.11%)  0/9 (0.00%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
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
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00959192     History of Changes
Other Study ID Numbers: 3134K1-2206
B2571009 ( Other Identifier: Alias Study Number )
First Submitted: August 13, 2009
First Posted: August 14, 2009
Results First Submitted: May 9, 2014
Results First Posted: January 1, 2016
Last Update Posted: January 1, 2016