NCT00065689

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

July 26, 2006

Status Verified

July 1, 2006

First QC Date

July 31, 2003

Last Update Submit

July 24, 2006

Conditions

Alzheimer's DiseaseDementia

Keywords

Alzheimer's diseaselight therapylong-term caredepressionsleepagitation

Interventions

high-intensity light therapyDEVICE

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of dementia
  • Residence on study units

You may not qualify if:

  • Bipolar disorder
  • Severe retinal (eye) disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Umstead Hospital

Butner, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementiaDepressionPsychomotor Agitation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorDyskinesiasNeurologic ManifestationsPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in Dementia

Study Officials

  • Philip D. Sloane, MD, MPH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

July 31, 2003

First Posted

August 1, 2003

Study Start

March 1, 2003

Study Completion

September 1, 2005

Last Updated

July 26, 2006

Record last verified: 2006-07

Locations

US(1)