Adults 45 to 90, any sex, with Mild Cognitive Impairment or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Cognition as Measured by the Neuropsychological Test Battery (NTB) Z-scoresPrimary· Baseline and day 171
NTB is a composite of multiple neuropsychological tests that provide a thorough assessment of the cognitive domains affected by early Alzheimer's Disease (AD), in particular, memory, executive function, attention and verbal fluency. 5 out of 9 NTB components were administered in the study, Rey Auditory Verbal Learning Test (RAVLT) immediate and delayed scores, Wechsler Memory Scale Digit Span, Controlled Word Association Test (COWAT) and Category Fluency Test (CFT).
For each component a raw score was converted to z-score that indicates the number of standard deviations away from the mean. Tot
Group
Value
95% CI
Canakinumab
0.225
± 0.116
Placebo
0.156
± 0.0905
Change From Baseline in Memory as Measured by the Total Composite NTB Memory Z-scoreSecondary· Baseline and day 171
Total Neuropsychological Test Battery memory composite score is a "memory function" score composed of the NTB RAVLT immediate and delayed scores.
For each component a raw score was converted to z-score that indicates the number of standard deviations away from the mean. Total Z-score was derived by averaging the two resulting z-scores. A change from baseline was calculated as post-baseline z-score minus pre-treatment z-score. A zero Z-score means no cognitive change, a negative value indicates decline, and a positive value means improvement.
Group
Value
95% CI
Canakinumab
0.461
± 0.1382
Placebo
0.463
± 0.1062
Change From Baseline in Executive Function as Measured by the Total Composite NTB Executive Function Z-scoreSecondary· Baseline and day 171
The total Neuropsychological Test Battery executive function composite score is an "executive function" score composed of the NTB Wechsler Memory Scale Digit Span, COWAT, and CFT.
For each component a raw score was converted to z-score that indicates the number of standard deviations away from the mean. Total Z-score was derived by averaging the two resulting z-scores. A change from baseline was calculated as post-baseline z-score minus pre-treatment z-score. A zero Z-score means no cognitive change, a negative value indicates decline, and a positive value means improvement.
Group
Value
95% CI
Canakinumab
0.111
± 0.1492
Placebo
-0.075
± 0.1251
Change From Baseline in Digit Symbol Substitution Test (DSST) Score - CANTABSecondary· Baseline and day 171
The DSST is an attention-demanding component of the Wechsler Adult Intelligence Scale-IV.
The DSST score is the number of digits coded correctly in a fixed amount of time. The DSST has a minimum of "0" correct responses and does not have a maximum; a higher number on the DSST represents better performance
The test was administered using CANTAB web based testing
Group
Value
95% CI
Canakinumab
1.96
± 1.37
Placebo
2.45
± 1.13
Change From Baseline in Neuropsychiatric Symptoms as Measured by the Neuropsychiatric Inventory (NPI) Total ScoreSecondary· Baseline and day 171
Neuropsychiatric Inventory (NPI) total score is globally recognized and the most frequently used assessment of neuropsychiatric symptoms in AD trials. NPI covers twelve neuropsychiatric domains. For each domain there are four scores, frequency (rated 1-4), severity (rated 1-3), domain total score (frequency x severity) and caregiver distress score (rated 0-5).
The NPI total score was calculated by adding 12 domain total scores together, and ranges from 0 to 144, with higher values indicating greater severity.
Group
Value
95% CI
Canakinumab
-1.4
± 7.76
Placebo
2.9
± 8.68
Change From Baseline in Neuropsychiatric Symptoms Associated Distress as Measured by the Neuropsychiatric Inventory Caregiver Distress (NPI-D) ScoreSecondary· Baseline and day 171
Neuropsychiatric Inventory (NPI) total score is globally recognized and the most frequently used assessment of neuropsychiatric symptoms in AD trials. NPI covers twelve neuropsychiatric domains. For each domain there are four scores, frequency (rated 1-4), severity (rated 1-3), domain total score (frequency x severity) and caregiver distress score (rated 0-5).
The caregiver distress score (NPI-D) was calculated by adding together the scores of the 12 individual NPI distress questions, and ranges from 0 to 60, with higher values indicating greater severity.
Group
Value
95% CI
Canakinumab
-2.7
± 7.70
Placebo
1.2
± 5.74
Change From Baseline in Mean eNeuropsychiatric at Home Caregiver Assessment ScoreSecondary· Baseline, day 85
Neuropsychiatric Inventory (NPI) total score is globally recognized and the most frequently used assessment of neuropsychiatric symptoms in AD trials. NPI covers twelve neuropsychiatric domains. For each domain there are four scores, frequency (rated 1-4), severity (rated 1-3), domain total score (frequency x severity) and caregiver distress score (rated 0-5).
The eNeuropsychiatric at-home assessment was calculated the same way as the in-clinic NPI by adding the12 domain total scores together. The eNeuropsychiatric at-home assessments were completed more frequently than the single time-point
Group
Value
95% CI
Canakinumab
0.983
± 3.7904
Placebo
-1.094
± 1.7083
Change From Baseline in Everyday Cognition Scale (ECog) Total ScoreSecondary· Baseline and day 171
Everyday Cognition (ECog) scale measures cognitively-relevant everyday abilities and is comprised of 39 items covering six cognitively-relevant domains: Everyday Memory, Everyday Language, Everyday Visuospatial Abilities, Everyday Planning, Everyday Organization, and Everyday Divided Attention. Each item is scored on a 4 point scale (1=better or no change compared to 10 years earlier, 2=questionable/occasionally worse, 3=consistently a little worse, 4=consistently much worse). An "I don't know" response is also included, in that case the item is not included in the calculation.
The total ECog
Group
Value
95% CI
Canakinumab
1.2
± 14.26
Placebo
3.4
± 11.79
Change From Baseline in eCognitive Testing Scores - SWM Between ErrorsSecondary· Baseline, day 85
Spatial Working Memory (SWM) is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. A trial begins with several colored squares (boxes) being shown on the screen. The overall aim is that the subject should find a blue 'token' in each of the boxes and use them to fill up an empty column. The subject must touch each box in turn until one opens with a blue 'token' inside (a search). Returning to an empty box already sampled on this search is an error.
SWM between errors is the number of times the subject incorrectly revisits a box i
Group
Value
95% CI
Canakinumab
-1.56
± 6.018
Placebo
-1.83
± 4.910
Change From Baseline in eCognitive Testing Scores - SWM StrategySecondary· Baseline, day 85
Spatial Working Memory (SWM) is a test of the subject's ability to retain spatial information and to manipulate remembered items in working memory. A trial begins with several colored squares (boxes) being shown on the screen. The overall aim is that the subject should find a blue 'token' in each of the boxes and use them to fill up an empty column. The subject must touch each box in turn until one opens with a blue 'token' inside (a search). Returning to an empty box already sampled on this search is an error.
SWM Strategy is the number of times a subject begins a new search pattern from the
Group
Value
95% CI
Canakinumab
-0.28
± 1.149
Placebo
-0.92
± 1.459
Change From Baseline in eCognitive Testing Scores - MTS Proportional Slowing 8-2 PatternsSecondary· Baseline, day 85
Match to Sample Visual Search (MTS) assesses attention and visual searching, with a speed accuracy trade-off. The participant is shown a complex visual pattern in the middle of the screen. After a brief delay, a varying number of similar patterns are shown in a circle of boxes around the edge of the screen. Only one of these patterns matches the pattern in the center of the screen, and the participant must indicate which it is by selecting it.
MTS proportional slowing 8-2 patterns is the difference in mean time between presentation of the response stimulus options and the subject selecting th
Group
Value
95% CI
Canakinumab
143.780
± 2871.0641
Placebo
77.573
± 2824.3325
Change From Baseline in eCognitive Testing Scores - PAL First Attempt Memory ScoreSecondary· Baseline, day 85
Pair associated learning (PAL): tests participants' visual memory/new learning using patterns randomly displayed in boxes on a screen. Participants are to touch the box where patterns first appeared.
PAL first attempt memory score is the number of times a subject choses the correct box on their first attempt when recalling the pattern locations. Ranges from 0 to 20 with higher score indicates a better outcome.
Group
Value
95% CI
Canakinumab
-0.17
± 2.716
Placebo
0.08
± 3.059
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose up to approximately 140 days post last dose (day 281).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Canakinumab
Serious: 2/16 (13%)
Deaths: 0/16
Placebo
Serious: 1/18 (6%)
Deaths: 0/18
Total
Serious: 3/34 (9%)
Deaths: 0/34
Serious adverse events (4 terms)
Reaction
System
Canakinumab
Placebo
Total
COVID-19
Infections and infestations
—
—
—
Streptococcal infection
Infections and infestations
—
—
—
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this platform study was to evaluate the effect of anti-inflammatory agents on cognition in early Alzheimer's disease. Additionally, the safety and tolerability and their effects on central and peripheral inflammation were evaluated. Due to early termination only a single agent could be studied.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06038526 — Evaluation of Canakinumab in High-Risk Former-Smokers
· Phase 2
· active not recruiting
NCT05984602 — A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclit
· Phase 1
· active not recruiting
NCT05401578 — Canakinumab for the Treatment of Postprandial Hypoglycemia
· Phase 3
· recruiting
NCT05641831 — Canakinumab for the Prevention of Progression to Cancer in Patients With Clonal Cytopenias of Unknown Significance, IMPA
· Phase 2
· recruiting
NCT05535738 — Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
· Phase 2, PHASE3
· recruiting
Other recruiting trials for Mild Cognitive Impairment
Currently open trials in the same condition.
NCT05791994 — EVASION: Effect of VisuAl Stimulation on attentION
· NA
· recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
· Phase 1
· recruiting
NCT07220694 — Effects of Sabroxy® Supplementation on Insulin Resistance and Cognitive Function in Adults With Mild Cognitive Impairmen
· NA
· recruiting
NCT06983769 — CPAP vs MAD for OSA in Patients With Cognitive Impairment. A Randomized Clinical Trial
· NA
· recruiting
NCT07318038 — The Use of Rhythmic Light Therapy in Mild Cognitive Impairment
· NA
· recruiting
Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary
· Phase 3
· not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa
· Phase 4
· not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
· not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy
· not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+
· Phase 1, PHASE2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 16 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04795466.