A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

Inclusion Criteria

Subjects who meet all of the following criteria are eligible to enroll in the arm of this trial reserved for subjects with AD:

• Japanese males or females at least 50 years of age, with probable AD according to the NINCDS-ADRDA criteria (McKhann et al., 1984);
• Subjects with mild/moderate dementia as evidenced by a MMSE score ranging from 10 to 24, boundaries included, at screening;
• Subjects whose history of cognitive decline has been gradual in onset and progressive over a period of at least 6 months. Evidence should be present indicating sustained memory deterioration in an otherwise cognitively normal subject, plus additional impairment in another cognitive function such as: orientation, judgment and problem solving, or functioning in personal care;
• Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status; and
• Subjects who signed an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved informed consent prior to any study procedures. If the subject is incapable of giving informed consent, the caregiver may consent on behalf of the subject (the subject must still confirm assent).

Subjects who meet all of the following criteria are eligible to enroll in the arm of this trial reserved for subjects with mild cognitive impairment:

• Japanese males or females at least 50 years of age;
• Subjects with complaint of memory or cognitive decline corroborated by an informant;
• Subjects with a Clinical Dementia Rating (CDR) of 0.5;
• Subjects with objective cognitive impairment or marginally normal cognition with a documented history of high cognitive performance;
• Have no obvious causes for their cognitive impairment (e.g., onset coincides with recent head trauma or stroke);
• Have sufficiently preserved general cognition and functional performance such that a diagnosis of AD cannot be made at the time of the screening visit;
• Subjects with essentially normal ADL;
• Subjects who are not demented;
• Subjects with an MMSE score > 24;
• Subjects who are presenting for initial diagnosis of cognitive impairment or who have presented for initial diagnosis of cognitive impairment within the past year;
• Subjects who live with or have regular visits from a responsible caregiver willing to provide information about the subject's cognitive status; and
• Subjects who signed an IRB/IEC approved informed consent prior to any study procedures.

Subjects who meet all of the following criteria are eligible to enroll in the arm of this trial reserved for cognitively normal volunteers:

• Japanese males or females at least 50 years of age;
• Subjects with an MMSE score >= 29, and are cognitively normal based on history and psychometric test battery at screening;
• Subjects who live with or have a reliable person who can verify their cognitive status; and
• Subjects who signed an IRB/IEC approved informed consent prior to any study procedures.

Exclusion Criteria

Subjects with any of the following are ineligible to enroll in this trial:

• A documented diagnosis of MCI for greater than 1 year (for subjects considered for the MCI group);
• Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, frontotemporal dementia, Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy;
• Have had or currently have a diagnosis of other dementing / neurodegenerative disease (e.g. Parkinson's disease, dementia with Lewy bodies, Lewy body variant AD, etc.);
• Have had or currently have a diagnosis of mixed dementia;
• Cognitive impairment resulting from:
• Acute cerebral trauma or post-traumatic brain injury, subdural hematoma, or injuries secondary to chronic trauma (e.g. sequela from boxing);
• Hypoxic cerebral damage regardless of etiology; e.g. cognitive or neurological