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Lutein and Alzheimer's Disease Study (LAD)

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ClinicalTrials.gov Identifier: NCT00596024
Recruitment Status : Unknown
Verified January 2008 by Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : January 16, 2008
Last Update Posted : January 16, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dietary Supplement: lutein/zeaxanthin Dietary Supplement: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lutein and Oxidative Stress in Alzheimer's Disease - A Pilot Study
Study Start Date : December 2007
Estimated Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Daily Lutein/zeaxanthin supplementation with a meal
Dietary Supplement: lutein/zeaxanthin
daily supplementation of lutein and zeaxanthin at dose of 12 mg/day
Placebo Comparator: 2 Dietary Supplement: placebo
placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients

Outcome Measures

Primary Outcome Measures :
  1. oxidative damage markers [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with moderately severe Alzheimer's disease
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596024

United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Wei Wang, PhD    503-418-2423    wangwe@ohsu.edu   
Contact: Joseph Quinn, MD    503-494-6976      
Principal Investigator: Wei Wang, PhD         
Sponsors and Collaborators
Oregon Health and Science University
Oregon Partnership for Alzheimer's Research
Principal Investigator: Wei Wang, PhD Oregon Health and Science University
More Information

Responsible Party: Wei Wang, PhD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00596024     History of Changes
Other Study ID Numbers: LAD
Alzheimer research fund
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders