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A Phase 1 Study to Evaluate ISIS 814907 in Mild Alzheimer's Disease

  • Research type

    Research Study

  • Full title

    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of Intrathecally Administered ISIS 814907 in Patients with Mild Alzheimer's Disease

  • IRAS ID

    217506

  • Contact name

    Cath Mummery

  • Contact email

    cath.mummery@uclh.nhs.uk

  • Sponsor organisation

    Ionis Pharmaceuticals, Inc.

  • Eudract number

    2016-002713-22

  • Duration of Study in the UK

    2 years, 5 months, 0 days

  • Research summary

    The main aim of the study is to evaluate the safety and tolerability of the study drug ISIS 814907 in patients with mild Alzheimer’s Disease as ISIS 814907 was never been tested in human before. Also the study will help to find out if the study drug will cause the human body to make less of a protein that builds up in the brain and makes it hard for one to think, remember and perform tasks which are the main symptoms of mild Alzheimer’s Disease.

    Male and female participants aged between 50-74 years with mild Alzheimer’s Disease will be eligible for the study after passing inclusion criteria outlined in the protocol during screening period of the study. Approximately 44 participants will be taking part in this study. The total number of participants selected for the study will be higher than 44 if some need to be replaced. Maximum of 64 participants will be selected for the study.

    Once selected, participants will be randomised to receive either study drug or placebo under four groups. These four groups are based on amount of dose of the study drug participants will receive. Under each group subsequently participants will be randomised in 3:1 to receive study drug or placebo. Participants will be in the study for approximately 44 weeks (10 months). The study drug will be injected into the cerebrospinal fluid via a lumbar puncture. The study will consist of a screening period of up to 8 weeks, a 13-week treatment period and a 23-week post-treatment period.

  • REC name

    London - Central Research Ethics Committee

  • REC reference

    17/LO/0440

  • Date of REC Opinion

    8 Jun 2017

  • REC opinion

    Further Information Favourable Opinion