Evaluation of [123I] MNI-330 and SPECT as a Marker of Beta-amyloid Protein Deposition

Study Overview
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Brief Summary
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The main objectives of this proposal are as follows: To assess the dynamic uptake and washout of 123-I MNI-330, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls To perform blood metabolite characterization of 123-I MNI-330 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-330 as a single photon computed tomography (SPECT) brain imaging agent Evaluate the test/retest reproducibility of 123-I MNI-330 and SPECT in AD subjects and healthy controls

Detailed Description
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The underlying goal of this study is to assess 123-I MNI-330 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with Alzheimers disease (AD) and 6 healthy controls (within +/- 2 years) 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.

Official Title
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Evaluation of [123I] MNI-330 and Single Photon Emission Computed Tomography (SPECT) as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: MNI-330 as a brain SPECT tracer of Beta-Amyloid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alzheimer's Subject Selection. Subjects who have a clinical diagnosis of mild to moderate Alzheimer's disease will be recruited for this study. The following criteria will be met for inclusion of AD subjects in this study: 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 and blood pregnancy test on day of 123-I MNI-330 injection. Healthy Control Subject Selection. Healthy control subjects who have no neurological disease will be recruited for this study. The following criteria will be met for inclusion of healthy control subjects in this study: The participant is 50 years or older. Written informed consent is obtained. Negative history of neurological or psychiatric illness based on evaluation by a research physician. Mini-Mental Status Exam score ≥28. For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-330 injection. Exclusion Criteria: Alzheimer's subjects will be excluded from participation for the following reasons: 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 Healthy control subjects will be excluded from participation for the following reasons: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Access [123I]MNI-330 and SPECT Imaging<br> | Drug: MNI-330 as a brain SPECT tracer of Beta-Amyloid<br>* Each subject will receive a bolus injection targeted to be 5 miCi and not to exceed 5.5 mCi of MNI-330. Following injection serial dynamic imaging will be obtained over 8 hrs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 MNI-330. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer, SPECT