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Use of [123I] AV39 and SPECT Imaging as a Marker of Protein Disposition in Subjects With Alzheimer Disease Compared to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00439010
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : April 24, 2008
Sponsor:
Collaborator:
Institute for Neurodegenerative Disorders
Information provided by:
Molecular NeuroImaging

Study Description
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Brief Summary:
The underlying goal of this study is to assess 123-I AV39 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects.

Condition or disease Intervention/treatment Phase
Alzheimers Disease Drug: [123I] AV 39 Phase 1

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 AV39. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I AV39 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 AV39. 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Diagnostic
Official Title: Evaluation of [123I] AV39 and SPECT as a Marker of Beta-Amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Study Start Date : February 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Assess the dynamic uptake and washout of 123-I AV39

Secondary Outcome Measures :
  1. Blood metabolite characterization of 123-I AV39 in healthy and AD subjects to determine the metabolic fate and nature of metabolites
  2. Evaluate the test/retest reproducibility of 123-I AV39 and SPECT in AD subjects and healthy controls

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT00439010


Locations
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United States, Connecticut
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Molecular NeuroImaging
Institute for Neurodegenerative Disorders
Investigators
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Principal Investigator: Danna Jennings, MD Molecular NeuroImaging, LLC
More Information
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Responsible Party: Danna Jennings, MD, MNI
ClinicalTrials.gov Identifier: NCT00439010    
Other Study ID Numbers: AV-39 001
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008
Keywords provided by Molecular NeuroImaging:
neurological
alzheimer
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders