Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics

Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta). Recent animal studies have shown that extended wakefulness is associated with increased production of these Abeta proteins and that sleep leads to a marked fall in their production.

Aim: The investigators aim to distinguish a similar effect of sleep disturbance on cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an important factor in AD development.

Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep deprivation night and before and after a control night with unrestricted sleep.

Expected results: The investigators expect sleep deprivation to lead to an increase in CSF Abeta levels, as compared to the levels in the control night.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Centre Nijmegen

Nijmegen, Gelderland, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent
Age 40-60 years
Male
Subject is in good health as established by medical history, physical examination, ECG and laboratory examination
Laboratory parameters (as described on in section 3.7 screening) should be within the normal ranges as applicable in RUNMC, Nijmegen, or clinically acceptable to the investigator
Normal sleep behaviour, Pittsburg Sleep Quality index score ≤5
MMSE 28 or higher
Medication free

Exclusion criteria

Presence of blood coagulopathy, established by medical history
Allergy to local anesthetic agents
Contra-indication for spinal catheter placement: medical history of compression of spinal cord, spinal surgery, skin infection, developmental abnormalities in lower spine
Subjects who are currently participating in another study or have participated in a clinical study within 30 days, based on their own report about participation history
Subjects with a history of drug or alcohol abuse
Subjects who are part of the study staff personnel or family members of the study staff personnel

Treatment and study plan

Sleep deprivation

Behavioral

subjects will undergo one night of full sleep deprivation

Primary outcomes

Amyloid beta

Time frame: 6 timepoints during one night of sleep deprivation

Subjects will undergo one night of sleep deprivation before, during and after which a total of 9 CSF samples (6ml each) will be drawn through a spinal catheter. From these CSF samples Amyloid beta will be analysed.

Sponsors and collaborators

Lead sponsor

University Medical Center Nijmegen

Other

Registry information

Official study title

Losing Sleep Over Alzheimer's Disease? Effects of Sleep Deprivation on Cerebrospinal Fluid Amyloid-beta Dynamics

Acronym: AWAKE

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 3, 2010
Registry last updated: May 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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