Status:
TERMINATED
Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Lead Sponsor:
Institute for Neurodegenerative Disorders
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief 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 an...
Detailed Description
The overall research questions to be addressed by this protocol are as follows: * To assess the dynamic uptake and washout of (123I) MNI-168, a potential imaging biomarker for β-amyloid burden in bra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00870519
Start Date
January 1 2009
End Date
December 1 2010
Last Update
April 3 2019
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510