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CompletedPhase 1ACTRN12619001728123

Pharmacologically Targeting Sleep Spindles to Improve Cognition in Ageing

Sponsor

Woolcock Institute of Medical Research

Enrollment

24 participants

Start Date

Mar 22, 2022

Study Type

Interventional

Conditions

Cognitively-intact ageing cohort which includes adults with and without subjective memory complaints

Summary

This is a proof of concept trial to deliver an early pharmacological intervention to enhance sleep spindle EEG features to optimise sleep quality and improve memory in those presenting with subjective memory complaints. Participants will receive a short-acting, non-benzodiazepine zolpidem or a placebo immediately prior to an overnight 8 hour sleep opportunity in a randomised order with a 5 to 10 day washout at the Woolcock Institute’s sleep and chronobiology laboratory using high-density electroencephalography (EEG). It will be hypothesized that memory consolidation will be significantly better with active drug compared to placebo.

Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 75 Yearss

Inclusion Criteria6

  • Males and Females;
  • Age 50-75;
  • Ability to perform neurobehavioural tests;
  • Able to give informed consent;
  • Fluent in English;
  • Cognitively intact (may have subjective memory complaint)

Exclusion Criteria17

  • Mild cognitive impairment, suspected or confirmed dementia or Mini Mental State Examination <24 ;
  • History of cerebrovascular events (e.g. stroke, TIA) associated with persisting cognitive changes
  • Neurological disorders (e.g. Parkinson’s Disease, Epilepsy, Multiple Sclerosis)
  • Myasthenia Gravis
  • Severe hepatic impairment
  • Acute ± severe pulmonary insufficiency
  • Head trauma with associated loss of consciousness > 30 mins
  • Psychiatric disorder including; Bipolar Disorder (I and II) and schizophrenia
  • Current major depressive episode
  • Currently regularly taking regular benzodiazepines, sedatives and hypnotics, and other sleep-affecting medications or any centrally active medications including anti-depressants /polypharmacy.
  • Current substance abuse or dependence (alcohol and/or other illicit substances)
  • Shift-work or trans-meridian travel within 14 days of assessment
  • Obstructive Sleep Apnoea and other sleep disorders;
  • Severe insomnia (insomnia severity index score of 22 or more)
  • Contraindication to MRI scanning.
  • Clinically significant medical condition that may hinder compliance with protocol as determined by the study physician.
  • Pregnancy

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Interventions

This proof of concept study will test a drug intervention to boost sleep spindle brain activity during non-REM sleep and to improve memory consolidation in cognitively-intact older adults. Zolpidem

This proof of concept study will test a drug intervention to boost sleep spindle brain activity during non-REM sleep and to improve memory consolidation in cognitively-intact older adults. Zolpidem (5mg) a short-acting, non-benzodiazepine, will be administered orally. Zolpidem is a widely prescribed hypnotic, has a low risk of dependence, fewer side effects than benzodiazepines and is safe for long-term use. Zolpidem and placebo will be administered orally in the evening prior to the 8-hour sleep opportunity on two nights in a randomised order with a 5-10 day washout between administration. Participants’ sleep will be monitored in an overnight study in the laboratory using high-density electroencephalography (EEG).

Locations(1)

Woolcock Institute of Medical Research - Glebe

NSW, Australia

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ACTRN12619001728123