Status:
COMPLETED
Anti-Oxidant Treatment of Alzheimer's Disease
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
Alzheimer's Disease Cooperative Study (ADCS)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60-85 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the safety and effectiveness of two anti-oxidant treatment regimens in patients with mild to moderate Alzheimer's disease. The anti-oxidant treatments include v...
Detailed Description
Oxidative damage has been shown to be a factor in Alzheimer's disease (AD), and some studies have suggested that supplemental anti-oxidants can decrease the risk of AD or slow its progression. There a...
Eligibility Criteria
Inclusion
- Men or women aged 60-85, inclusive
- Diagnosis of probable Alzheimer's disease
- English-speaking; Spanish-speaking if individual site allows
- Study partner or caregiver to assure compliance
- Mini-Mental State Examination score at screening visit greater than 14
- Female participants either surgically sterile or postmenopausal for over 1 year
- Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies
- Stable medications for 4 weeks prior to screening
- Able to take oral medications
- Modified Hachinski Ischemic Index less than or equal to 4
- CT or MRI since onset of memory impairment demonstrating the absence of a clinically significant focal lesion
- Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam, and clinical tests
Exclusion
- Significant neurologic disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder
- Major depression in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse
- History of invasive cancer within the past two years (excluding non-melanoma skin cancer)
- Contra-indications to lumbar puncture
- Use of any investigational agents within 30 days prior to screening
- Major surgery within 8 weeks prior to the Baseline Visit
- Uncontrolled cardiac conditions or severe unstable medical illnesses
- Antiretroviral therapy for human immunodeficiency virus (HIV)
- Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics
- Residence in skilled nursing facility
- Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol
- Note: Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the Project Director.
- Excluded Medications:
- Experimental drugs
- Coumadin
- Insulin
- Immunosuppressive agents: prednisone and other corticosteroids (taken orally or by injection), methotrexate, cyclophosphamide, cyclosporin, tacrolimus, etc.
- HIV protease inhibitors
- Neuroleptics and lithium
- Anti-cancer agents (exception: stable doses of hormonal therapy, e.g. Lupron, estrogen, are permitted)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00117403
Start Date
January 1 2006
End Date
September 1 2007
Last Update
April 3 2009
Active Locations (13)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of California- Irvine
Irvine, California, United States, 92697
3
University of California, San Diego
La Jolla, California, United States, 92037
4
University of California, Los Angeles
Los Angeles, California, United States, 90095