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A Randomized, Double-blind, Placebo-controlled Single Ascending Dose and Open-label Multi-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-APP in Adult Patients With Early-onset Alzheimer's Disease (EOAD)

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Trial Profile

A Randomized, Double-blind, Placebo-controlled Single Ascending Dose and Open-label Multi-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-APP in Adult Patients With Early-onset Alzheimer's Disease (EOAD)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Jul 2024

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At a glance

  • Drugs Mivelsiran (Primary)
  • Indications Alzheimer's disease; Cerebral amyloid angiopathy
  • Focus Adverse reactions
  • Sponsors Alnylam Pharmaceuticals
  • Most Recent Events

    • 02 May 2024 Planned End Date changed from 1 Jul 2025 to 1 Jul 2027.
    • 13 Dec 2023 According to an Alnylam Pharmaceuticals media release, the company plan to report initial Part B multi-dose data from the Phase 1 study in Alzheimer's disease in late 2024.
    • 02 Nov 2023 According to an Alnylam Pharmaceuticals media release, based on the achievement of specified clinical proof-of-principle criteria for the Phase 1 ALN-APP program, Alnylam received a $100 million milestone payment from Regeneron.
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