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

Stopped early · Phase 1

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00870519

Run by

Institute for Neurodegenerative Disorders

People needed

2

Starts

2009-01-01

Expected to finish

2010-12-01

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…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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