NCT00596024

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

January 4, 2008

Last Update Submit

August 8, 2019

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • oxidative damage markers

    3 months

Study Arms (2)

1

EXPERIMENTAL

Daily Lutein/zeaxanthin supplementation with a meal

Dietary Supplement: lutein/zeaxanthin

2

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

lutein/zeaxanthinDIETARY_SUPPLEMENT

daily supplementation of lutein and zeaxanthin at dose of 12 mg/day

1
placeboDIETARY_SUPPLEMENT

placebo capsules with the same size and coating as those of lutein/zeaxanthin supplements without active ingredients

2

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with moderately severe Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

LuteinZeaxanthins

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Wei Wang, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

December 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 12, 2019

Record last verified: 2019-08

Locations

US(1)