A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Primary endpoint(s) modified Show 8 more changesShow less
    • Trial completed
    • Final enrollment: 7 participants (planned 15)
    • Primary completion date changed from estimate of Dec 2026 to Mar 6, 2026
    • Study completion date changed from estimate of Dec 2026 to May 6, 2026
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 15 to 3
    • Site details revised at 2 of 2 sites
    • Study description expanded, about 2 words
  2. Sponsor changed: Elixiron Immunotherapeutics (Hong Kong) Ltd. to Elixiron Immunotherapeutics Inc.
    • Collaborators shortened, about 3 words
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Collaborators expanded, about 3 wordsv5
  5. Primary completion date: Mar 2026 to Dec 2026
    • Study completion date: Jun 2026 to Dec 2026
    • Site details revised at 1 of 2 sites
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 2v3
  2. Start date changed from estimate of Dec 2024 to Dec 16, 2024v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
An open-label, exploratory, phase II, proof-of concept, clinical study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or severe Alzheimer's disease
Trial Details
NCT Number NCT06745583
Lead Sponsor Elixiron Immunotherapeutics Inc.
Conditions
(from sponsor)		 Mild, Moderate, or Severe Alzheimer's Disease
Related terms Alzheimer Disease, Cognitive Dysfunction, Lymphoma, Follicular, Neurodegenerative Diseases, Neuroinflammatory Diseases
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov