Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Lutein and Alzheimer's Disease Study (LAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00596024
Recruitment Status : Terminated (Lack of enrollment)
First Posted : January 16, 2008
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
Oregon Partnership for Alzheimer's Research
Information provided by (Responsible Party):
Oregon Health and Science University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 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
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with moderately severe Alzheimer's disease
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Oregon Partnership for Alzheimer's Research
Investigators
Layout table for investigator information
Principal Investigator: Wei Wang, PhD Oregon Health and Science University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00596024    
Other Study ID Numbers: LAD
Alzheimer research fund
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders