ISRCTN29863753CompletedNot Applicable

Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light: a double-blind randomised controlled trial

etherlands Institute for Neuroscience (Netherlands)0 sites97 target enrollmentStarted: October 8, 2009Last updated: January 13, 2015

Conditions

Trial Snapshot

No summary available.

•1. For experimental group:
•1.1. Patients between 50 and 80 years of age
•1.2. Clinical diagnosis of probable (presenile) Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI) or Subjective Memory Complaints provided by a neurologist or gerontologist; AD according to the Diagnosis Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) or the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria and MCI following the MCI-standard set by Petersen (Petersen RC, et al: Neurology 2001, 56(9):1133-1142).
•1.3. Mini Mental State Exam (MMSE) score >=14
•2. For healthy control group:
•2.1. Healthy controls (age 50-80 years)
•2.2. Free of any clinical diagnosis of dementia
•2.3. Those without subjective memory complaints
•2.4. MMSE score =28

•Patients nor healthy controls are admitted to the study if any of the following are diagnosed:
•1. Any other neurological disorder, including narcolepsy
•2. Any psychiatric disorder, with the exception of mild depressive symptoms
•3. Serious problems with activities of daily living (ADL)
•4. Sleep apnoea or restless legs syndrome
•5. A serious eye disease incompatible with light therapy, such as aphakia or retinitis pigmentosa

Sponsor

etherlands Institute for Neuroscience (Netherlands)