Anti-Oxidant Treatment of Alzheimer's Disease

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: Alzheimer's Disease Cooperative Study (ADCS)
• Treatments: alpha-Tocopherol; Antioxidants; Ascorbic Acid; Thioctic Acid; Tocopherols; Tocotrienols; Ubiquinone; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)