ISRCTN29863753
Completed
Not 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 enrollmentOctober 8, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- etherlands Institute for Neuroscience (Netherlands)
- Enrollment
- 97
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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