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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00287248 |
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Date of registration:
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02/02/2006 |
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Primary sponsor: |
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Public title:
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Assess 123-I IMPY and SPECT Imaging as a Tool to Detect ß-Amyloid Deposition in the Brain of Patients With Alzheimer's Disease
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Scientific title:
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Evaluation of [123I] IMPY and SPECT as a Marker of Beta-Amyloid Protein Deposition in the Brain of Healthy Subjects and Patients With Alzheimer's Disease |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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45 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00287248 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Danna L Jennings, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institute for Neurodegenerative Disorders |
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Key inclusion & exclusion criteria
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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/ADRA) criteria.
- Mini-Mental Status Exam score > 16 and < 25.
- Patients have a diagnosis of probable AD for < 3 years prior to screening.
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.
- 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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer's Disease
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Intervention(s)
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Procedure: 123-I IMPY and SPECT Imaging
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Primary Outcome(s)
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Does 123-I IMPY demonstrate qualitatively increased radiotracer uptake in cortical regions consistent with ß-amyloid deposition in AD patients relative to controls
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Secondary Outcome(s)
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Can 123-I IMPY and SPECT provide a quantitative and reproducible measure of amyloid deposition
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Secondary ID(s)
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AMYLOID001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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