Evaluation of [123I] MNI-340 and SPECT as a Marker of Beta-Amyloid Protein Deposition

Stopped early · Phase 1

Conditions studied: Alzheimer's Disease

In brief

The main objectives of this proposal are as follows: To assess the dynamic uptake and washout of 123-I MNI-340, 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-340 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-340 as a single photon computed tomography (SPECT) brain imaging agent

Key facts

Study ID

NCT00968097

Run by

Institute for Neurodegenerative Disorders

People needed

12

Starts

2008-04-01

Expected to finish

2008-07-01

Last updated by the study team

2019-04-03

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 > 16 and < 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-340 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-340 injection.

You may not qualify if…

• 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.
• 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
• 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.
• The subject has participated in another clinical study within the previous 30 days.
• Pregnancy
• Clinically significant MRI evidence of vascular disease or neurologic disorder

Where it is running

• The Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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