Sleep problems in patients with mild to moderate Alzheimers Disease
Research type
Research Study
Full title
A double-blind, parallel group, randomized, placebo controlled study of the efficacy of Circadin® 2mg in alleviating sleep disturbances in patients with mild to moderate Alzheimer Disease (AD) treated with Acetylcholinesterase (AChE) inhibitor.
IRAS ID
28484
Contact name
Alan G Wade
Eudract number
2009-014388-38
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Alzheimer??s disease (AD) is a degenerative brain disorder and is the leading cause of dementia. In addition to the gradual worsening of memory, language and intellect that are the classic hallmarks of AD, the degenerative process also produces neurobehavioral symptoms that can be as stressful to patients and caregivers as the dementia itself. Sleep disturbances are among the more common neurobehavioral symptoms of AD, affecting up to 45% of patients. Night time awakenings can be extremely stressful for family members and caregivers. Sleep also has an important role in memory functions. There is some evidence that AD patients suffer from a melatonin deficiency which affects their sleep. Replacement of the deficient melatonin might potentially improve sleep and consequently memory performance.The study will compare the treatment effect of Circadin© (a new slow release formulation of melatonin) against placebo (a dummy tablet) on total sleep time in patients diagnosed with mild to moderate AD.Eligible participants will be assessed and seen at GP surgeries or at their place of residence in the West of Scotland. They will undergo a 2 week run in period and then be randomized on a 50/50 basis to receive 1 tablet daily of either Circadin© or placebo for a further 24 week treatment period followed by a 2 week run out period. Recruitment to the study ended in October 2011.
REC name
Scotland A REC
REC reference
09/MRE00/64
Date of REC Opinion
28 Sep 2009
REC opinion
Favourable Opinion