Back to resultsLutein and Alzheimer's Disease Study (LAD)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lutein/zeaxanthin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with moderately severe Alzheimer's disease
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Daily Lutein/zeaxanthin supplementation with a meal
Outcomes
Primary Outcome Measures
oxidative damage markers
Secondary Outcome Measures
Full Information
NCT ID
NCT00596024
First Posted
January 4, 2008
Last Updated
August 8, 2019
Sponsor
Oregon Health and Science University
Collaborators
Oregon Partnership for Alzheimer's Research
1. Study Identification
Unique Protocol Identification Number
NCT00596024
Brief Title
Lutein and Alzheimer's Disease Study
Acronym
LAD
Official Title
Lutein and Oxidative Stress in Alzheimer's Disease - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
December 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Health and Science University
Collaborators
Oregon Partnership for Alzheimer's Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Oxidative damage by free radicals may be involved in causing Alzheimer's disease (AD). Free radicals may lead to death of nerve cells and decline in brain function. Certain antioxidants may suppress this free radical damage associated with AD. Carotenoids are a family of naturally occurring antioxidants that have important functions for human health. Carotenoids are known to reduce oxidative damage, but their effects have not been studied in AD patients.
The objective of the study is to examine whether lutein supplementation helps to reduce oxidative damage from free radicals in AD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Daily Lutein/zeaxanthin supplementation with a meal
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
lutein/zeaxanthin
Intervention Description
daily supplementation of lutein and zeaxanthin at dose of 12 mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients
Primary Outcome Measure Information:
Title
oxidative damage markers
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with moderately severe Alzheimer's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Wang, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lutein and Alzheimer's Disease Study
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