- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00065689
High Intensity Light Therapy in Alzheimer's Disease
July 24, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
The purpose of this study is to determine whether bright light improves the sleep, mood, and behavior of persons with Alzheimer's disease and related dementias (AD) who live in long-term care settings and, if so, to determine the best timing for the light therapy.
The light levels being used in the study have been shown to improve depression in persons with seasonal affective disorder (SAD) and to relieve sleep problems in persons with jet lag and other body rhythm disturbances.
Because persons with AD often will not remain still in front of a fluorescent panel, this project has involved renovations in the study units that provide for even, regulated, high-intensity light in all public areas of the study settings.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
See Brief Summary
Study Type
Interventional
Enrollment
107
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Butner, North Carolina, United States, 27514
- John Umstead Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Diagnosis of dementia
- Residence on study units
Exclusion criteria:
- Bipolar disorder
- Severe retinal (eye) disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Philip D. Sloane, MD, MPH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2003
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
July 31, 2003
First Submitted That Met QC Criteria
July 31, 2003
First Posted (Estimate)
August 1, 2003
Study Record Updates
Last Update Posted (Estimate)
July 26, 2006
Last Update Submitted That Met QC Criteria
July 24, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT000212-01A1 (U.S. NIH Grant/Contract)
- SloaneP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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