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Sponsors and Collaborators: |
Institute for Neurodegenerative Disorders Alzheimer's Association Molecular NeuroImaging |
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Information provided by: | Institute for Neurodegenerative Disorders |
ClinicalTrials.gov Identifier: | NCT00287248 |
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 single photon emission computed tomography (SPECT) images of the brain serially over time to determine the relative localization of the radiopharmaceutical in regions of the cortex relative to background regions and develop an optimal technique of radiotracer administration (bolus or bolus with constant infusion). The researchers will then evaluate the utility of 123-I IMPY and SPECT in AD patients as an early diagnostic tool and subsequently serial evaluations of AD patients will be performed to determine if this technique may be useful as a tool for evaluation of progressive brain β-amyloid deposition in AD.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Procedure: 123-I IMPY and SPECT Imaging |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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's Disease |
Estimated Enrollment: | 45 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | June 2007 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
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 Alzheimer's disease (AD) and 20 healthy controls will be recruited to participate in this study. AD patients will be eligible to participate if they have a diagnosis of AD of less than 3 years duration. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo either a bolus injection or bolus injection followed by continuous infusion of 123-I IMPY. Following injection, subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I IMPY in plasma (both protein bound and free) over a 3.5 - 8 hour period. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I IMPY.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Institute for Neurodegenerative Disorders | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Danna L Jennings, MD | Institute for Neurodegenerative Disorders |
Study ID Numbers: | AMYLOID001 |
Study First Received: | February 2, 2006 |
Last Updated: | January 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00287248 |
Health Authority: | United States: Food and Drug Administration |
Alzheimer's Alzheimer's disease Alzheimer's disease (AD) |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Healthy |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |