Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
- Registration Number
- NCT00870519
- Lead Sponsor
- Institute for Neurodegenerative Disorders
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I123 MNI168 123-I MNI-168 brain imaging using I123MNI168 I 123-MNI-168 123-I MNI-168 - I 123-MNI-168 I-123-MNI-168 - I123 MNI168 I-123-MNI-168 brain imaging using I123MNI168
- Primary Outcome Measures
Name Time Method 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
Name Time Method To acquire initial safety data following injection of (123I) MNI-168. 1 year
Trial Locations
- Locations (1)
Institute for Neurodegenerative Disorders
🇺🇸New Haven, Connecticut, United States