Anti-Oxidant Treatment of Alzheimer's Disease

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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 vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).

Key facts

Study ID

NCT00117403

Run by

National Institute on Aging (NIA)

People needed

75

Starts

2006-01-01

Expected to finish

2007-09-01

Last updated by the study team

2009-04-03

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of California- Irvine — Irvine, California, United States
• University of California, San Diego — La Jolla, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Wien Center, Mount Sinai Medical Center — Miami Beach, Florida, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Medicine and Dentistry of New Jersey — Piscataway, New Jersey, United States
• Neurological Care of CNY — Syracuse, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — North Charleston, South Carolina, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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