Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double Blind Placebo Controlled Study On The Neuroprotective And Anti-Atherogenic Effects Of Palm TocotrienolRich Fraction(Palm Vitamin E)
Brief Summary: The purpose of the study is to assess the neuroprotective, anti atherogenic and hepatoprotective properties of tocotrienols (palm vitamin E) supplementation as determined by white matter lesion load on serial magnetic resonance imaging (MRI), carotid artery magnetic resonance angiography (MRA) and liver ultrasound (US) as well as lipid profile analysis.


Options:
A: 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)
B: INCLUSION CRITERIA

1. DISEASE CHARACTERISTICS:

   * Healthy male physicians practicing in the United States
   * Prior participation in the Physicians' Health Study I allowed
2. PATIENT CHARACTERISTICS:

   * Aged 50 years and over
   * No history of serious illness that would preclude study participation
   * No history of significant adverse events (e.g., rash or allergic reaction) attributed to study agents
3. PRIOR CONCURRENT THERAPY:

   * No other concurrent vitamin and/or multivitamin supplementation
   * No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)
C: Inclusion Criteria:

* Participant able to understand and has signed and dated the Informed Consent Form
* Participant can be either a male or female
* Participant is more than 35 years of age
* Participant has total cholesterol between 5.2 - 6.2 mmol/L and LDL cholesterol between 2.6 - 4.2 mmol/L
* Participant is able to comply with visits and medications
* Participant has normal liver function (total protein, total albumin, total globulin, total bilirubin, SGOT and SGPT)

Participants who satisfy the Inclusion and Exclusion Criteria for Study in General with one or more of the following conditions will be eligible for MRI screening:

* More than 40 years of age
* Stable hypertension requiring only out-patient management
* Diabetes mellitus requiring only out-patient management
* Ischaemic heart disease requiring only out-patient management
* Body mass index more than 25 (overweight or obese)

Exclusion Criteria:

* Female participants who are pregnant
* Participant has previously received vitamin E supplementation (tocotrienols or tocopherols) within the past 3 months at the time of recruitment
* Participant has a history of cancer or has undergone radiation therapy
* Participant has a history of major organ dysfunction, such as moderate or severe hepatic impairment, severe renal insufficiency, severe or unstable cardiovascular, respiratory, hematological, endocrinological, neurological or other somatic disorders resulting in previous hospitalization.
* Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
* Participant is requiring long term anti-epileptics, hypnotics, and chronic medications for hypercholesterolemia
* Participant has very high cholesterol levels, total cholesterol above 6.2 mmol/L and LDL cholesterol above 4.2 mmol/L, which require medical treatment.
* Participant is requiring long term non-steroidal anti-inflammatory (NSAID) medication.
* Participant has a history of hypersensitivity to vitamin E.
* Participant has signs of alcohol and drug dependence or abuse.
* Participant is unable to understand and comply with the elements in the consent form.

In addition, the participant must not have any contraindication to have MRI examinations including:

* Biostimulators (e.g. cardiac pacemaker and implanted spinal cord stimulator)
* Neurostimulators
* Aneurysm clips in the brain
* Cochlear implants
* Hearing aids
* Orthopaedic implants less than 2 months old
* Metal fragments in eyes Any further implants or foreign body not listed above should have the safety assessed by a radiologist prior to recruitment into the MRI study.
D: DISEASE CHARACTERISTICS:

* Healthy male volunteers
* Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry

  * Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer
* Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
* No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia

PATIENT CHARACTERISTICS:

Age:

* See Disease Characteristics

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* Systolic blood pressure \< 160 mm Hg
* Diastolic blood pressure \< 90 mm Hg
* No history of hemorrhagic stroke

Other:

* No malignancies within the past 5 years except basal cell or squamous cell skin cancer
* No uncontrolled medical illness
* No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
* No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
* Concurrent multivitamins allowed (supplied on study)
* No concurrent anticoagulation therapy (e.g., warfarin)
* Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed

  * Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel
* Concurrent anti-hypertension medication allowed
* No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)

Answer: C