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Prospective, Multicenter, First Part Randomized, Placebo-controlled, Parallel-group, Double-blind Period Followed by Open-label Trial Period to Evaluate Clinical Safety & Efficacy of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease: Proof-of-concept Study

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Prospective, Multicenter, First Part Randomized, Placebo-controlled, Parallel-group, Double-blind Period Followed by Open-label Trial Period to Evaluate Clinical Safety & Efficacy of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease: Proof-of-concept Study

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Apr 2024

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At a glance

  • Drugs Lithium citrate (Primary)
  • Indications Alzheimer's disease
  • Focus Proof of concept; Therapeutic Use
  • Acronyms NanoLi_AD
  • Sponsors Medesis Pharma SA

    • Most Recent Events

    • 29 Aug 2023 Planned End Date changed from 1 Jun 2024 to 1 Apr 2025.
    • 29 Aug 2023 Planned primary completion date changed from 1 May 2023 to 1 Jan 2024.
    • 20 Jul 2023 Study has been initiated in 7 centers in France, primary outcomes at 12 weeks intermediate analysis are expected mid-2023, final outcomes are expected mid 2024 according to trial design presented at the Alzheimer's Association International Conference 2023.
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