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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT04795466

Run by

Novartis Pharmaceuticals

People needed

34

Starts

2021-10-28

Expected to finish

2024-03-07

Last updated by the study team

2025-10-16

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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);

Where it is running

• Massachusetts General Hospital — Charlestown, Massachusetts, United States
• SUNY at Stony Brook — Stony Brook, New York, United States
• Novartis Investigative Site — Kuopio, Finland
• Novartis Investigative Site — Turku, Finland
• Novartis Investigative Site — Reykjavik, Iceland
• Novartis Investigative Site — Plymouth, Devon, United Kingdom
• Novartis Investigative Site — Guildford, Surrey, United Kingdom
• Novartis Investigative Site — London, United Kingdom
• Novartis Investigative Site — Motherwell, United Kingdom
• Novartis Investigative Site — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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