Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The underlying goal of this study is to assess 123-I MNI-168 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of Alzheimer's Disease (AD) research participants and similarly aged and gender matched healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Neurodegenerative Disorders

Criteria

Inclusion Criteria:

• Subjects who have a clinical diagnosis of AD will be recruited for this study

• The participant is 50 years or older

• Written informed consent is obtained

• Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria

• Subjects will have a clinical dementia rating (CDR) assessment score of ≥ 0.5 and < 2.0

• Modified Hachinski Ischemia Scale score of ≤ 4

• For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-168 injection

Exclusion Criteria:

• The subject has signs or symptoms of another neurodegenerative disease including Parkinson's disease, diffuse Lewy body dementia, or history of significant cerebrovascular disease

• The subject has clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness

• The subject has any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including gastrointestinal surgery)

• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease

• The subject has participated in another clinical study within the previous 30 days

• Clinically significant MRI evidence of vascular disease or alternative neurologic disorder

• Pregnancy