Study of the Efficacy and Safety of Various Anti-inflammatory Agents in Participants With Mild Cognitive Impairment or Mild Alzheimer's Disease

NCT04795466 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CADPT06A12201
• Study Type: interventional
• Target: 34
• Locations: 4 countries
• Sites: 10

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Keywords

Alzheimer disease; Mild Cognitive Impairment; Elderly adults; Adults; Memory loss; Dementia; Inflammation; ADPT06

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Cognition as Measured by the Neuropsychological Test Battery (NTB) Z-scores

  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. Total Z-score was derived by averaging all 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.

  Baseline and day 171

Secondary Outcomes (16)

• Change From Baseline in Memory as Measured by the Total Composite NTB Memory Z-score

  Baseline and day 171

• Change From Baseline in Executive Function as Measured by the Total Composite NTB Executive Function Z-score

  Baseline and day 171

• Change From Baseline in Digit Symbol Substitution Test (DSST) Score - CANTAB

  Baseline and day 171

• Change From Baseline in Neuropsychiatric Symptoms as Measured by the Neuropsychiatric Inventory (NPI) Total Score

  Baseline and day 171

• Change From Baseline in Neuropsychiatric Symptoms Associated Distress as Measured by the Neuropsychiatric Inventory Caregiver Distress (NPI-D) Score

  Baseline and day 171

Study Arms (2)

Canakinumab

EXPERIMENTAL

Canakinumab 150 mg SC once every 4 weeks for the first 2 doses followed by 300 mg SC once every 4 weeks for the subsequent 4 doses.

Biological: Canakinumab

Placebo

PLACEBO COMPARATOR

Matching placebo sub-cutaneous injections

Other: Placebo

Interventions

Canakinumab BIOLOGICAL

Biological subcutaneous injection

Also known as: ACZ885

Canakinumab

Placebo OTHER

Matching placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥ 45 years and ≤ 90 years at the time of signing the informed consent;
• Participant has a reliable study partner or caregiver can accompany the participant to all visits;
• A diagnosis of probable MCI due to AD or mild AD according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria;
• Confirmed amyloid and tau positivity via CSF sampling performed at screening;
• Mini-Mental State Examination (MMSE) total score of 20 to 24 (inclusive) at screening; OR, MMSE total score of 25-30 (inclusive) plus a DSST score at least 0.5 standard deviation (SD) below normative data at screening.

You may not qualify if:

• Use of an investigational agent or an approved product with the intent to modulate inflammation or modulate the course of AD (e.g., Tau ASOs, gene therapy, amyloid or tau vaccine):
• Previous use of small molecules is allowed if discontinued for at least five half-lives, or at least 30 days from when the expected pharmacodynamic effect has returned to baseline prior to screening, whichever is longer
• Previous use of monoclonal or polyclonal antibodies or other biologics is allowed if discontinued for at least five half-lives prior to screening
• Current medical or neurological condition that might impact cognition or performance on cognitive assessments, e.g., MCI not due to AD, non-Alzheimer dementia, Huntington's disease, Parkinson's disease, stroke, schizophrenia, bipolar disorder, active major depression, multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), active seizure disorder, or history of traumatic brain injury associated with loss of consciousness and ongoing residual transient or permanent neurological signs/symptoms including cognitive deficits, and/or associated with skull fracture;
• Diagnosis of vascular dementia prior to screening (e.g., modified Hachinski Ischaemic Scale score \> 6 or those who meet the NINDS AIREN criteria for vascular dementia);

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (10)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

SUNY at Stony Brook

Stony Brook, New York, 11794-8161, United States

Location

Novartis Investigative Site

Kuopio, 70210, Finland

Location

Novartis Investigative Site

Turku, 20520, Finland

Location

Novartis Investigative Site

Reykjavik, 101, Iceland

Location

Novartis Investigative Site

Plymouth, Devon, PL6 8BT, United Kingdom

Location

Novartis Investigative Site

Guildford, Surrey, GU27YD, United Kingdom

Location

Novartis Investigative Site

London, W1G 9JF, United Kingdom

Location

Novartis Investigative Site

Motherwell, ML1 4UF, United Kingdom

Location

Novartis Investigative Site

Southampton, SO30 3JB, United Kingdom

Location

Related Links

• A Plain Language Trial Summary is available on www.novctrd.com

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Memory Disorders; Dementia; Inflammation

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 12, 2021
• Study Start: October 28, 2021
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: October 16, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

FI (2); GB (5); IC (1); US (2)