- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00448799
Evaluation of [123I] AV83 and SPECT in Patients With Alzheimer Disease in Comparison to Healthy Controls
Evaluation of [123I] AV83 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately 20 patients with Alzheimer's disease (AD) and 10 healthy controls will be recruited to participate in this study. 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 a bolus injection of 123-I AV83. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV83 in plasma (both protein bound and free) over a period of up to 6 hours.
Subjects may be asked to undergo a second imaging visit between 2 and 6 weeks following the initial imaging visit following similar procedures to the initial imaging visit to evaluate the reproducibility of the imaging measure using this procedure. 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 AV83. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.
For those subjects undergoing repeat imaging visits, the data from the initial scan will be compared to the second scan to determine which offers the reproducibility of the imaging outcome measure.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Molecular NeuroImaging
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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/ADRDA) criteria.
- Mini-Mental Status Exam score < 25.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- Geriatric Depression Scales (GDS) ≤ 10.
- For females, non-child bearing potential or negative urine or blood pregnancy test on day of 123-I AV39 injection.
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.
- The subject has a 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.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the dynamic uptake and washout of 123-I AV83
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood metabolite characterization of 123-I AV39 in healthy and AD subjects to determine the metabolic fate and nature of metabolites
Time Frame: one year
|
one year
|
Evaluate the test/retest reproducibility of 123-IAv83 and SPECT in AD subjects and healthy controls.
Time Frame: one year
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AV-83 001
- 07-033
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimers Disease
-
Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute... and other collaboratorsRecruitingDementia | Alzheimers Disease | Alzheimers Disease, FamilialUnited States, Canada, Italy, Argentina, Australia, Brazil, Colombia, France, Germany, Ireland, Japan, Mexico, Netherlands, Puerto Rico, Spain, United Kingdom
-
Washington University School of MedicineNational Institute on Aging (NIA); Alzheimer's Association; Eisai Inc.; Accelerating...RecruitingDementia | Alzheimers Disease | Alzheimers Disease, FamilialUnited States, Canada, Italy, Argentina, Australia, Colombia, Netherlands, Puerto Rico, Spain, United Kingdom, France, Ireland, Mexico, Brazil, Japan, Germany
-
Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute... and other collaboratorsCompletedDementia | Alzheimers Disease | Alzheimers Disease, FamilialUnited States, Canada, France, Spain, Ireland, Australia, Puerto Rico, United Kingdom
-
Washington University School of MedicineHoffmann-La Roche; Genentech, Inc.; National Institute on Aging (NIA); Alzheimer...SuspendedDementia | Alzheimers Disease | Alzheimers Disease, FamilialUnited States, Canada, Italy, France, Spain, Ireland, Argentina, Australia, Colombia, Germany, Mexico, Netherlands, Puerto Rico, United Kingdom
-
Northwestern UniversityPatient-Centered Outcomes Research InstituteCompletedAlzheimers, Falls, Aging in PlaceUnited States
-
BiogenTerminatedAlzheimers DiseaseUnited States
-
Hoffmann-La RocheCompleted
-
Avid RadiopharmaceuticalsCompleted
-
Avid RadiopharmaceuticalsTerminatedAlzheimers DiseaseUnited States
-
University of AarhusCompleted
Clinical Trials on [123-I] AV-83 Injection and Imaging Procedures
-
Institute for Neurodegenerative DisordersMolecular NeuroImagingCompletedAlzheimers DiseaseUnited States
-
Institute for Neurodegenerative DisordersMolecular NeuroImagingTerminated
-
Institute for Neurodegenerative DisordersUnited States Department of Defense; University of OklahomaCompletedParkinson DiseaseUnited States
-
GE HealthcareQuintiles, Inc.; H2O Clinical LLCCompletedVentricular Dysfunction, Left | Heart Failure (HF)United States
-
Mayo ClinicRecruitingThyroid Gland Follicular CarcinomaUnited States
-
GE HealthcareABX CRO; H2O Clinical LLC; TransPerfect; Advanced Clinical, LLC; TFS; AG Mednet Inc.; ICON CEAC and other collaboratorsTerminatedHeart FailureUnited States, Spain, Canada, France, Netherlands, Poland, Czechia, Italy, Germany, Hungary
-
GE HealthcareApproved for marketingNeuroblastomaUnited States
-
University of PittsburghGE HealthcareCompletedStress Induced CardiomyopathyUnited States
-
Mayo ClinicEnrolling by invitationDementia | Mild Cognitive Impairment | Parkinsonism | REM Sleep Behavior DisorderUnited States
-
National Cancer Institute (NCI)Active, not recruitingAnatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage IV Breast Cancer AJCC v8 | Metastatic Triple-Negative Breast Carcinoma | Unresectable Triple-Negative Breast CarcinomaUnited States