Alzheimers Disease Clinical Trial
Official title:
Evaluation of [123I] AV83 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Verified date | May 2008 |
Source | Molecular NeuroImaging |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The underlying goal of this study is to assess 123-I AV83 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2008 |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Molecular NeuroImaging | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Molecular NeuroImaging | Institute for Neurodegenerative Disorders |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the dynamic uptake and washout of 123-I AV83 | one year | ||
Secondary | Blood metabolite characterization of 123-I AV39 in healthy and AD subjects to determine the metabolic fate and nature of metabolites | one year | ||
Secondary | Evaluate the test/retest reproducibility of 123-IAv83 and SPECT in AD subjects and healthy controls. | one year |
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