Pharmacologically Targeting Sleep Spindles to Improve Cognition in Ageing

Phase 1

Recruiting

• Conditions: Cognitively-intact ageing cohort which includes adults with and without subjective memory complaints; Neurological - Dementias

• Registration Number: ACTRN12619001728123
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Last Update Posted: 16 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Males and Females;
2. Age 50-75;
3. Ability to perform neurobehavioural tests;
4. Able to give informed consent;
5. Fluent in English;
6. Cognitively intact (may have subjective memory complaint)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in overnight memory consolidation scores (declarative and procedural) as assessed by word-pair association declarative task and finger tapping task.[At Visit 1 and Visit 2]

Secondary Outcome Measures

Name	Time	Method
Change in sleep spindle density per minute of N2 NREM as assessed by high-density electroencephalography.[At Visit 1 and Visit 2];Structural and functional brain MRI markers derived from MRI scan[Baseline visit]