Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

Study Overview
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Brief Summary
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The underlying goal of this study is to assess 123-I MNI-168 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of Alzheimer's Disease (AD) research participants and similarly aged and gender matched healthy subjects.

Detailed Description
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The overall research questions to be addressed by this protocol are as follows: To assess the dynamic uptake and washout of (123I) MNI-168, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in Alzheimer's (AD) subjects and similarly aged and gender matched healthy controls. To perform blood metabolite characterization of (123I) MNI-168 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of (123I) MNI-168 as a single photon computed tomography (SPECT) brain imaging agent. To acquire initial safety data following injection of (123I) MNI-168. Obtain test/retest reproducibility information in AD subjects with (123I) MNI-168 based on initial studies.

Official Title
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Evaluation of [123I] MNI-168 and 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's Disease

Intervention / Treatment
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* Drug: I-123-MNI-168
* Drug: 123-I MNI-168


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have a clinical diagnosis of AD will be recruited for this study The participant is 50 years or older Written informed consent is obtained Participants have a clinical diagnosis of probable Alzheimer's disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria Subjects will have a clinical dementia rating (CDR) assessment score of ≥ 0.5 and < 2.0 Modified Hachinski Ischemia Scale score of ≤ 4 For females, non-child bearing potential or negative urine and blood pregnancy test on day of 123-I MNI-168 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 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 The subject has participated in another clinical study within the previous 30 days Clinically significant MRI evidence of vascular disease or alternative neurologic disorder 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I 123-MNI-168<br> | Drug: I-123-MNI-168<br>* Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.<br>Drug: 123-I MNI-168<br>* Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.<br>|
| Experimental: I123 MNI168<br>brain imaging using I123MNI168 | Drug: I-123-MNI-168<br>* Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.<br>Drug: 123-I MNI-168<br>* Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain, |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To acquire initial safety data following injection of (123I) MNI-168. |  | 1 year | 

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