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Lutein and Alzheimer's Disease Study (LAD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2008 by Oregon Health and Science University.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Oregon Partnership for Alzheimer's Research
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00596024
First received: January 4, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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 Intervention Phase
Alzheimer's Disease Dietary Supplement: lutein/zeaxanthin Dietary Supplement: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

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

Estimated Enrollment: 16
Study Start Date: December 2007
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Inclusion Criteria:

  • Diagnosed with moderately severe Alzheimer's disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596024

Locations
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
Investigators
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
Study First Received: January 4, 2008
Last Updated: January 4, 2008

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

ClinicalTrials.gov processed this record on September 18, 2017