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Safety, tolerability, PK & PD of LSD in elderly healthy subjects

  • Research type

    Research Study

  • Full title

    A Phase 1, single-centre, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of very low dose lysergic acid diethylamide (5µg, 10 µg, 20µg) in healthy volunteers aged 55-75 years old

  • IRAS ID

    177579

  • Contact name

    Shlomi Raz

  • Contact email

    shlomi.raz@eleusisbenefitcorp.com

  • Sponsor organisation

    Eleusis Benefit Corporation PBC

  • Eudract number

    2015-000426-11

  • Duration of Study in the UK

    0 years, 3 months, 21 days

  • Research summary

    The new medicine being tested in this study is a compound called lysergic acid diethylamide (LSD). Research into the cognitive effects of LSD was common in the 1950s and 1960s and since then, very little research has been done. The Sponsor is investigating the therapeutic potential of low dose LSD and its potential medical applications, particularly its potential use in the treatment of Alzheimer's disease. This study is the first in a programme of studies looking at symptom relief and potential disease modifying effects of LSD in Alzheimer's disease. This study will look at the safety, tolerability, pharmacokinetics and pharmacodynamics of low dose LSD in elderly volunteers.

    The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body and excreted (removed from the body). This is called the pharmacokinetics (PK) of the drug. A further aim of the study is to look at the possible effects that the study drug has on learning ability, mood, sensory system and body movement.

    This study will recruit healthy, non-smoking, males and females (of non-childbearing potential) between the ages of 55 and 75 years (inclusive). A total of 48 subjects will take part in the study.

    Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored closely throughout the clinical study. Blood samples for pharmacokinetic analysis will be collected. A number of memory, knowledge, learning, awareness, mood and movement tests will be completed throughout the study in order to evaluate the cognitive effects of low dose LSD.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    15/LO/0664

  • Date of REC Opinion

    6 May 2015

  • REC opinion

    Favourable Opinion