Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease
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 vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).


Options:
A: Inclusion Criteria:

1. Diagnoses of possible or probable Alzheimer's disease (NINCDS-ADRDA)
2. Presence of a caregiver (friend or relative) who can assume responsibility for medication compliance, can accompany the patient to all visits, and rate patient's condition
3. Written informed consent from both the patient (or surrogate) and caregiver
4. An MMSE score between 12 and 26 inclusive
5. Administration of a maintenance dosage of donepezil (5-10mg/d), rivastigmine (6-12mg/d) or rivastigmine (Exelon) patch (4.6 mg or 9.5 mg), galantamine or galantamine ER (16-24mg/d) for a minimum of 4 weeks prior to randomization
6. Agreement not to take vitamin E supplements and/or memantine outside of the study (daily multivitamin is permitted containing up to 100 IU alpha-tocopherol)

Exclusion Criteria:

1. A non-Alzheimer primary dementia (e.g., vascular dementia, Lewy body dementia, fronto-temporal dementia, vitamin B-12 deficiency, hypothyroidism)
2. Current major depression, delirium, alcohol or psychoactive substance abuse or dependency, schizophrenia, or delusional disorder as defined by DSM-IV
3. Presence of any uncontrolled systemic illness that would interfere with participation in the study or a life expectancy of less than one year
4. Pregnant or intention to become pregnant
5. Enrollment in another interventional clinical trial
6. Current prescription with more than one AChE inhibitor
7. Current prescription for warfarin
8. Use of vitamin E supplements in the past 2 weeks
9. Use of memantine in the past 4 weeks or known intolerance
10. Estimated creatinine clearance less than 5ml/min (Cockcroft-Gault formula)
11. Use of amantadine in the past 2 weeks
B: Inclusion Criteria:

* 60 years of age and older
* English speaking
* Not living in a skilled or intermediate care level nursing facility
* No use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial
* A Mini-Mental State Exam (MMSE) score ≥ 23

Exclusion Criteria:

* A cognitive deficit greater than that indicated according to the MMSE score
* A clinical diagnosis of AD and/or related disorders
* A psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence
* Bleeding disorders
* Aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests
* Gastrointestinal disorders causing impaired absorption of the study supplements
* Insulin-dependent diabetes
* Major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure
* Hematologic or oncologic disorders treated with chemotherapy in the previous two years
* Active chemotherapy or radiation treatment for cancer
* Current cigarette smoking
* More than three major medical or psychiatric hospitalizations in the past year
* Diagnosis of a terminal illness
* A T score \> 70 on the Global Severity Index of the Brief Symptoms Inventory (BSI)
* A score ≥ 29 on the Beck Depression Inventory-II (BDI) (15)
* Prescription and OTC sympathomimetic amines and antihistamines within 2 days of an assessment visit
* Cognition enhancing drugs consumption such as Donepezil, Rivastigmine, Galantamine, and Tacrine
* Coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants
* Cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial
* Participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function
C: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
* must be able to swallow pills

Exclusion Criteria:

* known or suspected bipolar disorder
D: 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)

Answer: D