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| Sponsor: | Oregon Health and Science University |
|---|---|
| Collaborator: |
Oregon Partnership for Alzheimer's Research |
| Information provided by: | Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00596024 |
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 II |
| 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 |
| 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 |
|---|---|
|
1: Experimental
Daily Lutein/zeaxanthin supplementation with a meal
|
Dietary Supplement: lutein/zeaxanthin
daily supplementation of lutein and zeaxanthin at dose of 12 mg/day
|
| 2: Placebo Comparator |
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 |
Inclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Wei Wang, PhD | Oregon Health and Science University |
More Information
| Responsible Party: | Oregon Health and Science University ( Wei Wang, PhD ) |
| 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 |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
