Please select the eligibility criteria that correspond to the clinical trial below.
Title: Alzheimer's Disease Neuroimaging Initiative
Brief Summary: The purpose of this study is to examine how brain imaging technology can be used with other tests to measure the progression of mild cognitive impairment (MCI) and early Alzheimer's disease (AD). This information will aid future clinical trials by providing a standard assessment tool to measure the effects of treatments being studied.


Options:
A: Inclusion Criteria:

* Male or female
* 50 years of age or older
* Residing in the community at baseline (includes assisted living facilities, but excludes long-term care nursing facilities)
* MMSE (Mini-Mental State Examination) at screen of 14-26 (inclusive)
* No medical contraindications to study participation
* Fluent in English or Spanish
* Corrected vision and hearing sufficient for compliance with testing procedures
* Supervision available for study medication
* Caregiver/study partner to accompany participant to all visits
* Study partner must have direct contact with the participant more than 2 days/week
* Able to ingest oral medication
* Daily DHA consumption less than or equal to 200 mg/day in prior two months estimated by an abbreviated DHA food frequency questionnaire
* Neuroimaging consistent with the diagnosis of AD at some time after the onset of the memory decline
* Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the investigator
* Stable use of cholinesterase inhibitors and memantine is permitted if doses are stable for 4 months prior to enrollment

Exclusion Criteria:

* Non-AD dementia
* Residence in a long-term care facility at baseline
* History of clinically significant stroke
* Modified Hachinski Ischemia score ≥ 4
* Current evidence or history in past two years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
* Sensory impairment which would prevent subject from participating in or cooperating with the protocol
* Use of another investigational agent within two months
* Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational new drug including clinically significant or unstable hematologic, hepatic, cardiovascular (including history of ventricular fibrillation or ventricular tachycardia), pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality
* Active neoplastic disease (skin tumors other than melanoma may be included; participants with stable prostate cancer may be included at the discretion of the Project Director)
B: Inclusion Criteria:

* The patient has dementia according to DSM IV criteria.
* The patient has an MMSE less than or equal to 26.
* The patient lives in his/her home.
* The patient is in the charge of a carer.
* Informed consent for participation in the study by the responsible relative and, if possible, from the patient or legal guardian.

Exclusion Criteria:

* The patient lives in an institution.
* The patient is in a terminal situation.
* The patient does not have a main carer.
* Patient has a nasogastric feed.
C: Inclusion Criteria:

Participants will be classified as either MCI patients, AD patients, or normal controls. General Inclusion Criteria will apply to all groups, with specific criteria for each group as described below:

General (applies to each category):

* Between 55 and 90 years of age (Currently, ADNI sites are only recruiting volunteers age 70-90 among people with no memory problems)
* Study partner or caregiver to accompany patient to all scheduled visits
* Fluent in English or Spanish
* Permitted medications stable for at least 4 weeks prior to screening
* Adequate visual and auditory acuity to allow neuropsychological testing
* Good general health with no additional diseases expected to interfere with the study
* Women must be two years post-menopausal or surgically sterile
* Willing and able to complete all baseline assessments, and to participate in the 2-3 year protocol
* Willing to undergo neuroimaging and provide DNA and plasma samples as specified
* Completed 6 grades of education or sufficient work history to exclude mental retardation
* Modified Hachinski score \<=4
* Geriatric Depression Scale \<6

Specific Criteria for MCI and AD patients:

* Memory complaint by patient or study partner
* Abnormal memory function score on Wechsler Memory Scale (adjusted for education)
* Mini-Mental State Exam score between 24 and 30 (MCI) or 20 and 26 (AD)
* Clinical Dementia Rating = 0.5; Memory Box score at least 0.5 (MCI) or 1.0 (AD)

Exclusion Criteria:

* Any significant neurologic disease other than Alzheimer's disease
* Abnormal baseline MRI
* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body
* Major depression, bipolar disorder, history of schizophrenia
* History of alcohol or substance abuse or dependency within the past 2 years
* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
* Clinically significant laboratory abnormalities
* Residence in skilled nursing facility
* Participation in clinical studies involving neuropsychological measures being collected more than one time per year

Specific Exclusion Criteria for MCI and AD:

* Psychotic features, agitation or behavioral problems within the last 3 months which could lead to difficulty complying with the protocol.

Prohibited medications:

* Specific psychoactive medications (for example, certain antidepressants, anti-anxiety medications, sleeping pills, etc.)
* Warfarin (Coumadin)
* Investigational agents
D: Inclusion Criteria: Alzheimer's disease with MMSE 15-30, living in own homes, treated with stable dose of acetylcholine esterase inhibitor for \>3 months and remaining on that treatment for the study period

Exclusion Criteria: Already treated with omega-3 fatty acids, NSAIDs, warfarin, being an alcohol abuser, suffering from serious concomitant disease or not having a caregiver

Answer: C