Use of [123I] AV39 and SPECT Imaging as a Marker of Protein Disposition in Subjects With Alzheimer Disease Compared to Healthy Subjects

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The underlying goal of this study is to assess 123-I AV39 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects.

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

Details

• Lead Sponsor: Molecular NeuroImaging
• Collaborator: Institute for Neurodegenerative Disorders

Criteria

Inclusion Criteria:

• The participant is 50 years or older.

• Written informed consent is obtained.

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

• Mini-Mental Status Exam score < 25.

• Modified Hachinski Ischemia Scale score of ≤ 4.

• Geriatric Depression Scales (GDS) ≤ 10.

• For females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-I AV39 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 a 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.

• Pregnancy