Status:
COMPLETED
Use of [123I] AV39 and SPECT Imaging as a Marker of Protein Disposition in Subjects With Alzheimer Disease Compared to Healthy Subjects
Lead Sponsor:
Molecular NeuroImaging
Collaborating Sponsors:
Institute for Neurodegenerative Disorders
Conditions:
Alzheimers Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief 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.
Detailed Description
Approximately 20 patients with Alzheimer's disease (AD) and 10 healthy controls will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00439010
Start Date
February 1 2007
End Date
January 1 2008
Last Update
April 24 2008
Active Locations (1)
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1
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States, 06510