Lutein and Alzheimer's Disease Study (LAD)

The recruitment status of this study is unknown because the information has not been verified recently.
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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

No publications provided

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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014