Assess 123-I IMPY and SPECT Imaging as a Tool to Detect β-Amyloid in the Brain
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|ClinicalTrials.gov Identifier: NCT00287248|
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : March 7, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: [123I] IMPY & SPECT Imaging||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of [123I] IMPY and SPECT as a Marker of Beta-amyloid Protein Deposition in the Brain of Healthy Subjects and Patients With Alzheimer Disease|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||March 2008|
Experimental: Assess [123I] IMPY & SPECT Imaging
To assess [123I] IMPY & SPECT Imaging
Drug: [123I] IMPY & SPECT Imaging
Subjects will be injected with 7mCi of [123I]IMPY, followed by SPECT imaging
- Does 123-I IMPY demonstrate qualitatively increased radiotracer uptake in cortical regions consistent with β-amyloid deposition in AD patients relative to controls [ Time Frame: 2 years ]
- Can 123-I IMPY and SPECT provide a quantitative and reproducible measure of amyloid deposition [ Time Frame: 2 years ]
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287248
|United States, Connecticut|
|Institute for Neurodegenerative Disorders|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna L Jennings, MD||Institute for Neurodegenerative Disorders|
|Responsible Party:||Danna Jennings, MD, Principal Investigator, Institute for Neurodegenerative Disorders|
|Other Study ID Numbers:||
|First Posted:||February 6, 2006 Key Record Dates|
|Last Update Posted:||March 7, 2014|
|Last Verified:||March 2014|
Alzheimer disease (AD)
Central Nervous System Diseases
Nervous System Diseases