Clinical trial NCT00870519: Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer disease
Lead sponsor: Institute for Neurodegenerative Disorders
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 2
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain,
timeFrame: 1 year
Secondary outcomes:
measure: To acquire initial safety data following injection of (123I) MNI-168.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Institute for Neurodegenerative Disorders
name: Danna Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References: