A Phase 2 interventional study of ACC-001 and QS-21 in Alzheimer Disease, sponsored by Pfizer. Completed at 10 sites in Japan. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-01-01.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Biological: ACC-001 · Other: QS-21
Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
Biological: ACC-001
Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
Other: QS-21
Placebo, IM injection, Day 1, month 3, 6, 9, 12
Other: PBS
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12
IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12
IM injection, Day 1, month 3, 6, 9, 12
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
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
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.
Time frame: Baseline up to 24 months
Number of Participants With Abnormalities in Neurological Examination
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
Anti-a-beta IgG Titer at Specified Visits
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
Time frame: Baseline up to 24 months
Anti-a-beta IgM Titer at Specified Visits
Geometric mean of anti-a-beta IgM titer from pre-study through Week 104
Time frame: Baseline up to 24 months
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.
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 stuy, 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
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.
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
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.
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), WMSVerbal 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
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.
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
| Milestone | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 | 6 | 6 | 4 |
| Completed | 4 | 6 | 5 | 5 | 3 | 5 | 4 |
| Not completed | 2 | 0 | 1 | 1 | 3 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Caregiver request | 2 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Investigator request | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Subject request | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Group home admission | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Caregiver could not attend the subject | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
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)
| Participants | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Mild | 5 | 6 | 4 | 5 | 3 | 6 | 3 |
| Moderate | 0 | 0 | 0 | 1 | 2 | 0 | 0 |
| Severe | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.
| Participants | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Abnormal-inconsistent with AD | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Abnormal-consistent with AD | 6 | 6 | 6 | 6 | 6 | 5 | 4 |
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.
| Participants | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Total | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Mental Status | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Speech | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Cranial Nerves | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Visual field | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Sensory | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Motor | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Coordination | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gait | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Primitive reflexes | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Tendon reflexes | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Romberg | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
| Units/mL | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Pre-study (n=6, 6, 6, 6, 6, 6, 4) | 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) | 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, 6, 6, 6, 6, 6, 4) | 62.3 (35.4 to 110.0) | 50.0 (50.0 to 50.0) | 86.1 (21.3 to 347.9) | 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 6 (n=6, 6, 6, 6, 6, 6, 4) | 65.3 (32.9 to 129.7) | 50.0 (50.0 to 50.0) | 105.4 (43.4 to 255.8) | 50.0 (50.0 to 50.0) | 58.9 (38.7 to 89.5) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 10 (n=6, 6, 5, 6, 6, 6, 4) | 70.9 (28.9 to 174.4) | 50.0 (50.0 to 50.0) | 93.5 (28.8 to 303.0) | 59.2 (38.3 to 91.5) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 14 (n=6, 6, 5, 6, 6, 5, 4) | 2468.3 (775.0 to 7861.2) | 50.0 (50.0 to 50.0) | 8976.5 (680.6 to 118398.0) | 163.7 (29.5 to 908.5) | 2166.0 (390.7 to 12007.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 16 (n=6, 6, 5, 6, 6, 5, 4) | 1383.1 (340.9 to 5612.4) | 50.0 (50.0 to 50.0) | 4886.1 (348.5 to 68510.7) | 135.9 (25.6 to 720.8) | 1506.4 (297.6 to 7623.9) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 24 (n=6, 6, 5, 6, 6, 5, 4) | 476.2 (54.7 to 4148.3) | 50.0 (50.0 to 50.0) | 1427.3 (80.1 to 25425.0) | 113.4 (29.4 to 436.7) | 518.9 (91.4 to 2938.6) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 28 (n=6, 6, 5, 6, 6, 5, 4) | 3025.4 (1089.9 to 8398.6) | 50.0 (50.0 to 50.0) | 6815.7 (180.5 to 257414.9) | 324.6 (28.3 to 3728.9) | 7088.0 (1939.0 to 25910.8) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 30 (n=6, 6, 5, 6, 6, 5, 4) | 2340.1 (715.0 to 7659.1) | 50.0 (50.0 to 50.0) | 6016.6 (190.4 to 190127.4) | 287.6 (24.6 to 3359.6) | 5989.4 (1366.6 to 26250.5) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 34 (n=6, 6, 5, 6, 6, 5, 4) | 1689.7 (371.7 to 7681.8) | 50.0 (50.0 to 50.0) | 5482.8 (194.8 to 154346.1) | 214.7 (26.1 to 1765.7) | 3730.2 (885.6 to 15711.5) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 38 (n=6, 6, 5, 6, 6, 5, 4) | 4806.1 (2395.8 to 9641.1) | 50.0 (50.0 to 50.0) | 5751.3 (301.4 to 109732.2) | 353.5 (33.0 to 3785.7) | 10540.9 (3111.3 to 35711.8) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 40 (n=6, 6, 5, 6, 6, 5, 4) | 5147.1 (2523.9 to 10496.7) | 50.0 (50.0 to 50.0) | 4215.3 (174.2 to 101984.8) | 288.1 (32.2 to 2573.6) | 8889.6 (2565.3 to 30805.1) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 50 (n=6, 6, 5, 6, 6, 5, 4) | 2083.4 (1077.9 to 4026.8) | 50.0 (50.0 to 50.0) | 2792.0 (144.6 to 53925.7) | 162.0 (31.3 to 839.0) | 4184.8 (921.0 to 19015.0) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 54 (n=4, 6, 5, 6, 6, 5, 4) | 7028.9 (1100.8 to 44879.8) | 50.0 (50.0 to 50.0) | 4316.0 (312.0 to 59700.9) | 467.9 (81.4 to 2689.7) | 12638.9 (5577.9 to 28638.3) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 56 (n=4, 6, 5, 6, 6, 5, 4) | 7274.7 (1037.3 to 51016.9) | 50.0 (50.0 to 50.0) | 3642.5 (175.7 to 75527.4) | 372.7 (78.5 to 1769.7) | 8644.2 (3365.0 to 22205.8) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 66 (n=5, 6, 5, 6, 6, 5, 4) | 3841.6 (825.2 to 17883.9) | 50.0 (50.0 to 50.0) | 3069.8 (165.5 to 56949.5) | 207.0 (46.8 to 915.6) | 4555.6 (1016.8 to 20411.1) | 147.9 (7.3 to 3006.4) | 50.0 (50.0 to 50.0) |
| Week 78 (n=4, 6, 5, 5, 6, 5, 4) | 2599.1 (215.5 to 31342.0) | 50.0 (50.0 to 50.0) | 2236.1 (155.3 to 32198.4) | 231.0 (34.2 to 1559.2) | 2484.6 (571.3 to 10806.5) | 50.0 (50.0 to 50.0) | 50.0 (50.0 to 50.0) |
| Week 91 (n=4, 0, 1, 0, 0, 1, 0) | 1870.6 (159.8 to 21900.7) | NA (NA to NA) | 2959.0 (NA to NA) | NA (NA to NA) | NA (NA to NA) | 50.0 (NA to NA) | NA (NA to NA) |
| Week 104 (n=4, 0, 1, 0, 0, 1, 0) | 1403.1 (112.1 to 17561.2) | NA (NA to NA) | 2557.0 (NA to NA) | NA (NA to NA) | NA (NA to NA) | 50.0 (NA to NA) | NA (NA to NA) |
Geometric mean of anti-a-beta IgM titer from pre-study through Week 104
| Units/mL | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Pre-study (n=6, 6, 6, 6, 6, 6, 4) | 25.0 (25.0 to 25.0) | 31.7 (17.3 to 58.1) | 25.0 (25.0 to 25.0) | 32.9 (16.3 to 66.4) | 31.0 (17.8 to 53.9) | 36.1 (14.0 to 93.2) | 37.6 (10.3 to 137.9) |
| Week 2 (n=6, 6, 6, 6, 6, 6, 4) | 38.0 (17.5 to 82.6) | 32.5 (16.5 to 63.9) | 56.6 (13.9 to 231.4) | 32.1 (16.9 to 60.7) | 116.6 (26.6 to 511.8) | 40.9 (16.2 to 103.2) | 38.0 (10.0 to 144.7) |
| Week 6 (n=6, 6, 6, 6, 6, 6, 4) | 51.0 (15.9 to 163.5) | 34.9 (19.5 to 62.5) | 51.1 (15.8 to 165.2) | 37.9 (18.7 to 77.0) | 123.0 (25.9 to 584.8) | 41.2 (16.2 to 105.1) | 37.3 (10.4 to 133.4) |
| Week 10 (n=6, 6, 5, 6, 6, 6, 4) | 53.7 (15.4 to 188.0) | 35.4 (19.5 to 64.4) | 58.6 (13.7 to 251.3) | 32.1 (16.9 to 61.0) | 128.4 (30.2 to 546.2) | 40.5 (17.3 to 94.9) | 37.4 (10.4 to 134.5) |
| Week 14 (n=6, 6, 5, 6, 6, 5, 4) | 395.6 (12.8 to 12238.1) | 38.3 (18.9 to 77.5) | 357.1 (43.7 to 2920.6) | 52.6 (20.7 to 133.5) | 614.7 (125.8 to 3002.9) | 47.7 (14.9 to 153.3) | 97.1 (1.3 to 7277.6) |
| Week 16 (n=6, 6, 5, 6, 6, 5, 4) | 380.4 (9.4 to 15415.0) | 37.6 (19.3 to 73.2) | 330.1 (48.0 to 2271.7) | 57.7 (20.7 to 161.0) | 683.8 (80.2 to 5829.6) | 46.3 (14.1 to 152.5) | 35.4 (11.7 to 107.6) |
| Week 24 (n=6, 6, 5, 6, 6, 5, 4) | 204.0 (4.4 to 9434.1) | 34.7 (20.4 to 59.2) | 208.6 (44.6 to 975.7) | 58.8 (19.2 to 180.1) | 586.9 (60.2 to 5724.2) | 37.1 (12.4 to 110.6) | 35.9 (11.4 to 113.2) |
| Week 28 (n=6, 6, 5, 6, 6, 5, 4) | 651.0 (47.9 to 8850.3) | 41.4 (17.7 to 96.6) | 356.7 (50.9 to 2501.4) | 77.7 (16.7 to 362.3) | 2706.8 (366.9 to 19970.2) | 58.6 (17.2 to 199.2) | 37.9 (10.1 to 142.4) |
| Week 30 (n=6, 6, 5, 6, 6, 5, 4) | 949.1 (88.1 to 10223.9) | 40.6 (18.4 to 89.5) | 719.1 (81.7 to 6327.1) | 79.0 (17.9 to 349.3) | 3456.7 (381.6 to 31311.7) | 47.4 (22.9 to 98.0) | 39.4 (9.2 to 168.5) |
| Week 34 (n=6, 6, 5, 6, 6, 5, 4) | 446.7 (20.4 to 9760.9) | 38.7 (19.0 to 78.6) | 666.0 (80.9 to 5481.4) | 62.3 (20.1 to 192.9) | 2182.0 (235.7 to 20199.3) | 43.2 (17.0 to 109.3) | 38.0 (10.0 to 144.7) |
| Week 38 (n=6, 6, 5, 6, 6, 5, 4) | 473.5 (32.9 to 6813.1) | 39.1 (18.9 to 80.8) | 702.1 (201.8 to 2443.2) | 99.2 (24.6 to 400.2) | 2639.4 (368.5 to 18904.8) | 48.8 (22.1 to 107.8) | 39.4 (9.3 to 167.3) |
| Week 40 (n=6, 6, 5, 6, 6, 5, 4) | 509.6 (38.5 to 6736.7) | 38.0 (19.2 to 75.2) | 574.8 (192.7 to 1714.8) | 83.6 (19.0 to 367.4) | 2545.5 (313.6 to 20661.2) | 45.9 (21.8 to 96.6) | 37.0 (10.6 to 128.9) |
| Week 50 (n=6, 6, 5, 6, 6, 5, 4) | 223.8 (15.2 to 3301.7) | 37.8 (18.8 to 76.1) | 432.4 (140.8 to 1328.1) | 71.5 (27.0 to 189.3) | 1418.2 (230.1 to 8741.4) | 61.2 (29.1 to 128.6) | 38.2 (9.9 to 146.9) |
| Week 54 (n=4, 6, 5, 6, 6, 5, 4) | 836.2 (4.7 to 147881.4) | 37.9 (19.2 to 74.8) | 450.0 (186.4 to 1086.3) | 140.9 (25.3 to 782.7) | 1668.1 (309.0 to 9005.8) | 51.2 (21.4 to 122.5) | 36.5 (10.9 to 122.2) |
| Week 56 (n=4, 6, 5, 6, 6, 5, 4) | 678.8 (4.3 to 108248.9) | 36.9 (19.6 to 69.6) | 422.3 (180.7 to 986.6) | 119.4 (18.3 to 780.5) | 1507.7 (309.5 to 7344.5) | 42.4 (17.0 to 105.3) | 34.6 (12.3 to 97.6) |
| Week 66 (n=5, 6, 5, 6, 6, 5, 4) | 371.0 (16.3 to 8454.7) | 37.1 (19.4 to 71.0) | 331.1 (131.3 to 834.6) | 105.3 (15.9 to 698.4) | 1058.7 (226.9 to 4939.1) | 56.3 (12.7 to 249.0) | 35.4 (11.7 to 106.5) |
| Week 78 (n=4, 6, 5, 5, 6, 5, 4) | 450.1 (6.9 to 29432.6) | 39.9 (18.6 to 85.5) | 209.8 (81.9 to 537.8) | 134.2 (13.3 to 1357.2) | 759.3 (135.9 to 4242.2) | 32.7 (15.6 to 68.5) | 34.1 (12.7 to 92.1) |
| Week 91 (n=4, 0, 1, 0, 0, 1, 0) | 321.8 (5.8 to 17755.5) | NA (NA to NA) | 60.0 (NA to NA) | NA (NA to NA) | NA (NA to NA) | 25.0 (NA to NA) | NA (NA to NA) |
| Week 104 (n=4, 0, 1, 0, 0, 1, 0) | 226.1 (4.6 to 11037.7) | NA (NA to NA) | 54.0 (NA to NA) | NA (NA to NA) | NA (NA to NA) | 25.0 (NA to NA) | NA (NA to NA) |
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 stuy, 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.
| Units on a scale | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Week 12 (n=6, 6, 5, 6, 6, 6, 4) | 4.06 ± 6.45 | -2.00 ± 2.86 | 1.93 ± 5.51 | -0.94 ± 2.72 | -1.28 ± 3.74 | 1.28 ± 4.95 | 2.92 ± 1.13 |
| Week 26 (n=6, 6, 5, 6, 6, 5, 4) | 2.22 ± 4.88 | 0.78 ± 4.63 | -1.20 ± 1.17 | 1.67 ± 4.30 | -1.78 ± 2.45 | 1.93 ± 9.59 | 1.33 ± 3.27 |
| Week 36 (n=6, 6, 5, 6, 6, 5, 4) | 4.89 ± 7.53 | -0.50 ± 2.75 | -0.93 ± 1.53 | 0.56 ± 3.94 | -1.17 ± 4.88 | 2.93 ± 5.08 | 3.92 ± 4.15 |
| Week 52 (n=6, 6, 5, 6, 6, 5, 4) | 5.83 ± 9.41 | -2.56 ± 4.18 | -1.73 ± 2.24 | 3.56 ± 4.81 | -2.00 ± 3.75 | 5.80 ± 7.39 | 0.92 ± 2.60 |
| Week 78 (n=4, 6, 5, 5, 6, 5, 4) | 8.50 ± 10.09 | -0.33 ± 3.03 | -0.07 ± 4.23 | 2.47 ± 3.90 | -0.06 ± 5.16 | 6.47 ± 12.32 | 4.50 ± 4.39 |
| Week 104 (n=4, 0 1, 0, 0, 1, 0) | 5.92 ± 8.86 | NA ± NA | 0.00 ± NA | NA ± NA | NA ± NA | 6.33 ± NA | NA ± NA |
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.
| Units on a scale | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Week 12 (n=4, 5, 4, 6, 5, 5, 4) | 0.8 ± 4.1 | -0.8 ± 3.6 | 5.1 ± 7.4 | -3.5 ± 7.0 | -3.0 ± 11.8 | -8.8 ± 10.8 | 3.9 ± 6.8 |
| Week 26 (n=4, 4, 4, 6, 5, 5, 4) | 2.1 ± 9.5 | 1.8 ± 5.3 | 6.8 ± 6.8 | -1.8 ± 6.9 | -0.6 ± 3.3 | -5.4 ± 13.2 | 4.1 ± 16.0 |
| Week 36 (n=4, 4, 5, 6, 5, 5, 4) | 1.4 ± 9.1 | 4.9 ± 6.9 | 3.7 ± 4.4 | -2.7 ± 6.3 | -1.7 ± 9.3 | -6.8 ± 11.5 | -1.4 ± 15.1 |
| Week 52 (n=4, 5, 5, 6, 5, 5, 4) | -7.8 ± 15.6 | -3.3 ± 21.7 | 4.2 ± 5.3 | -8.3 ± 21.0 | 0.8 ± 16.1 | -11.4 ± 9.1 | 2.8 ± 10.4 |
| Week 78 (n=2, 5, 4, 5, 5, 5, 4) | -12.0 ± 3.8 | -16.7 ± 26.5 | -1.3 ± 9.0 | -2.9 ± 9.7 | -1.0 ± 12.4 | -14.4 ± 10.0 | 3.4 ± 9.3 |
| Week 104 (n=2, 0, 1, 0, 0, 1, 0) | -0.8 ± 1.2 | NA ± NA | 0.0 ± NA | NA ± NA | NA ± NA | -32.5 ± NA | NA ± NA |
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), WMSVerbal 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.
| Z-score | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Week 12 (n=6, 6, 5, 6, 6, 6, 4) | 0.048 ± 0.314 | 0.002 ± 0.198 | 0.043 ± 0.306 | 0.030 ± 0.220 | -0.007 ± 0.266 | 0.058 ± 0.226 | 0.203 ± 0.092 |
| Week 26 (n=6, 6, 5, 6, 6, 5, 4) | 0.114 ± 0.378 | -0.028 ± 0.420 | 0.272 ± 0.148 | 0.095 ± 0.404 | 0.374 ± 0.278 | 0.121 ± 0.180 | 0.215 ± 0.449 |
| Week 36 (n=6, 6, 5, 6, 6, 5, 4) | 0.148 ± 0.573 | 0.188 ± 0.219 | 0.367 ± 0.222 | 0.267 ± 0.294 | 0.232 ± 0.388 | 0.061 ± 0.353 | 0.465 ± 0.494 |
| Week 52 (n=6, 6, 5, 6, 6, 5, 4) | 0.171 ± 0.585 | 0.183 ± 0.274 | 0.247 ± 0.189 | -0.036 ± 0.312 | 0.255 ± 0.454 | 0.184 ± 0.320 | 0.411 ± 0.357 |
| Week 78 (n=4, 6, 5, 5, 6, 5, 4) | 0.138 ± 0.597 | -0.047 ± 0.291 | 0.132 ± 0.261 | -0.160 ± 0.332 | 0.246 ± 0.515 | 0.184 ± 0.631 | 0.258 ± 0.399 |
| Week 104 (n=4, 0, 1, 0, 0, 1, 0) | 0.048 ± 0.647 | NA ± NA | 0.345 ± NA | NA ± NA | NA ± NA | 0.118 ± 0.118 | NA ± NA |
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.
| Units on a scale | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Week 4 (n=6, 6, 5, 6, 6, 6, 4) | -0.8 ± 2.6 | -0.2 ± 2.7 | 1.8 ± 2.5 | 1.0 ± 1.7 | 1.5 ± 2.4 | 1.0 ± 2.1 | 1.0 ± 2.4 |
| Week 8 (n=6, 6, 5, 6, 6, 6, 4) | 0.5 ± 2.3 | 0.8 ± 2.8 | 1.4 ± 2.5 | 1.8 ± 1.6 | 2.0 ± 1.7 | 1.0 ± 2.7 | -0.3 ± 1.7 |
| Week 12 (n=6, 6, 5, 6, 6, 6, 4) | -0.2 ± 3.6 | 0.3 ± 2.7 | -0.6 ± 2.5 | 0.8 ± 2.1 | 2.3 ± 2.9 | 0.7 ± 2.2 | 0.5 ± 2.4 |
| Week 16 (n=6, 6, 5, 6, 6, 5, 4) | -0.2 ± 2.4 | 0.0 ± 1.1 | -0.6 ± 2.9 | 2.8 ± 1.6 | 1.2 ± 3.1 | 1.0 ± 4.3 | 0.3 ± 3.2 |
| Week 26 (n=6, 6, 5, 6, 6, 5, 4) | -1.0 ± 4.7 | 0.5 ± 1.6 | 0.4 ± 3.6 | 0.3 ± 1.5 | 0.2 ± 2.9 | 0.2 ± 2.8 | 0.5 ± 3.1 |
| Week 30 (n=6, 6, 5, 6, 6, 5, 4) | -1.3 ± 4.4 | 0.5 ± 1.8 | -1.6 ± 4.3 | 1.2 ± 1.3 | 1.3 ± 2.2 | 1.4 ± 4.1 | 0.3 ± 2.1 |
| Week 36 (n=6, 6, 5, 6, 6, 5, 4) | -3.0 ± 5.8 | 0.0 ± 2.9 | 0.0 ± 2.3 | 0.8 ± 1.6 | 2.2 ± 2.8 | -0.2 ± 2.2 | -0.5 ± 3.1 |
| Week 40 (n=6, 6, 5, 6, 6, 5, 4) | -2.5 ± 4.3 | 1.3 ± 4.2 | -0.4 ± 4.8 | 1.8 ± 1.7 | 1.8 ± 1.5 | 0.6 ± 2.1 | -2.3 ± 3.6 |
| Week 52 (n=6, 6, 5, 6, 6, 5, 4) | -2.7 ± 5.4 | -0.3 ± 2.0 | -1.6 ± 3.4 | -0.3 ± 3.6 | 1.8 ± 2.6 | -0.8 ± 4.2 | -1.5 ± 1.7 |
| Week 78 (n=4, 6, 5, 5, 6, 5, 4) | -4.8 ± 6.8 | -0.8 ± 4.5 | -1.2 ± 2.2 | -0.8 ± 1.9 | 0.3 ± 2.3 | -2.0 ± 2.9 | 0.3 ± 2.6 |
| Week 104 (n=4, 0, 1, 0, 0, 1, 0) | -4.3 ± 7.4 | NA ± NA | 4.0 ± NA | NA ± NA | NA ± NA | -6.0 ± NA | NA ± NA |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACC-001 3 Micrograms +QS-21 | — | 1/6 (16.7%) | 6/6 (100%) |
| ACC-001 10 Micrograms | — | 0/6 (0%) | 6/6 (100%) |
| ACC-001 10 Micrograms + QS-21 | — | 0/6 (0%) | 4/6 (66.7%) |
| ACC-001 30 Micrograms | — | 0/6 (0%) | 6/6 (100%) |
| ACC-001 30 Micrograms + QS-21 | — | 1/6 (16.7%) | 5/6 (83.3%) |
| QS-21 | — | 0/6 (0%) | 6/6 (100%) |
| Phosphate Buffered Saline (PBS) | — | 0/4 (0%) | 3/4 (75%) |
| Event | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms + QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Angina pectorisCardiac disorders | 0/6 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/4 |
| Duodenal ulcerGastrointestinal disorders | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/4 |
| Cholecystitis infectiveInfections and infestations | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/4 |
| ContusionInjury, poisoning and procedural complications | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/4 |
| Event | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms + QS-21 | QS-21 | Phosphate Buffered Saline (PBS) |
|---|---|---|---|---|---|---|---|
| Prostatic specific antigen increasedInvestigations | 0/5 | 0/2 | 1/1 | 0/2 | 0/4 | 0/2 | 0/1 |
| NasopharyngitisInfections and infestations | 2/6 | 0/6 | 2/6 | 3/6 | 2/6 | 1/6 | 2/4 |
| Injection site erythemaGeneral disorders | 0/6 | 0/6 | 2/6 | 1/6 | 0/6 | 0/6 | 0/4 |
| CataractEye disorders | 1/6 | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 | 1/4 |
| ConjunctivitisEye disorders | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 1/4 |
| Dental cariesGastrointestinal disorders | 0/6 | 1/6 | 1/6 | 1/6 | 0/6 | 0/6 | 1/4 |
| EructationGastrointestinal disorders | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 1/4 |
| VomitingGastrointestinal disorders | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 1/4 |
| OedemaGeneral disorders | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 1/4 |
| OnychomycosisInfections and infestations | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 | 1/4 |
| Age, Continuous(Years) | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 71.33 ± 9.35 | 69.50 ± 6.92 | 73.00 ± 7.67 | 70.17 ± 3.13 | 66.00 ± 10.79 | 67.00 ± 9.19 | 69.50 ± 4.80 | 69.50 ± 7.68 |
| Sex: Female, Male(Participants) | ACC-001 3 Micrograms +QS-21 | ACC-001 10 Micrograms | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms | ACC-001 30 Micrograms +QS-21 | QS-21 | Phosphate Buffered Saline (PBS) | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 1 | 4 | 5 | 4 | 2 | 4 | 3 | 23 |
| Male | 5 | 2 | 1 | 2 | 4 | 2 | 1 | 17 |
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