Evaluation of [123I] MNI-330 and SPECT as a Marker of Beta-amyloid Protein Deposition
| Status: | Terminated |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/5/2019 |
| Start Date: | March 2008 |
| End Date: | September 30, 2008 |
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
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
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
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.
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.
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
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