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

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04795466
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — BIOLOGICAL
    Biological subcutaneous injection
  • Placebo — OTHER
    Matching placebo subcutaneous injection

Study Details

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 Dates

Start date
Oct 28, 2021
Status verified
Oct 2025
Primary completion
Mar 7, 2024
Completion
Mar 7, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab
    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.
  • Placebo Comparator: Placebo
    Matching placebo sub-cutaneous injections

Primary Outcome Measure

Change From Baseline in Cognition as Measured by the Neuropsychological Test Battery (NTB) Z-scores [ Time Frame: Baseline and day 171 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalCharlestownMassachusetts02129-
SUNY at Stony BrookStony BrookNew York11794-8161-

Find similar trials in Charlestown, MA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Massachusetts General Hospital· Charlestown, MASUNY at Stony Brook· Stony Brook, NY

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