Status:
COMPLETED
Assess 123-I IMPY and SPECT Imaging as a Tool to Detect β-Amyloid in the Brain
Lead Sponsor:
Institute for Neurodegenerative Disorders
Collaborating Sponsors:
Alzheimer's Association
Molecular NeuroImaging
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
This research is designed to obtain efficacy and safety information for 123-I IMPY as an imaging biomarker for Alzheimer's disease (AD). The distribution of this agent will be measured by obtaining si...
Detailed Description
All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImanging (MNI) in New Haven, CT. Approximately 25 patients with mild to moderate Alzhei...
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/ADRA) criteria.
- Mini-Mental Status Exam score \> 16 and \< 25.
- Patients have a diagnosis of probable AD for \< 3 years prior to screening.
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.
- Subjects with an iodine allergy.
- The subject has a clinically significant clinical laboratory value and/or 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 thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder.
- The subject has received an investigational drug within 60 days before the screening visit.
- Pregnancy
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00287248
Start Date
February 1 2006
End Date
March 1 2008
Last Update
March 7 2014
Active Locations (1)
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1
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510