Anti-Oxidant Treatment of Alzheimer's Disease
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring dementia, anti-oxidant, biomarkers, alpha-tocopherol, CoQ
Eligibility 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)
Sites / Locations
- University of Arizona
- University of California- Irvine
- University of California, San Diego
- University of California, Los Angeles
- Wien Center, Mount Sinai Medical Center
- University of Kentucky
- University of Medicine and Dentistry of New Jersey
- Neurological Care of CNY
- Case Western Reserve University
- Oregon Health Sciences University
- University of Pennsylvania
- Medical University of South Carolina
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
1
2
3
vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals, plus two placebo wafers three times per day with meals
CoQ 400 mg, compounded as a wafer, two wafers three times per day with meals, plus one placebo capsule three times per day with meals
two placebo wafers three times per day with meals, plus one placebo capsule three times per day with meals