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

This study has been terminated.
(Assessment of data shows inadequate brain uptake, suggesting the tracer is inadequate as an imaging biomarker of brain amyloid.)
Sponsor:
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00870519
First received: March 26, 2009
Last updated: February 24, 2011
Last verified: February 2011

March 26, 2009
February 24, 2011
January 2009
January 2010   (final data collection date for primary outcome measure)
To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain, [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00870519 on ClinicalTrials.gov Archive Site
To acquire initial safety data following injection of (123I) MNI-168. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects
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

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.

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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Alzheimer's Disease
  • Drug: I-123-MNI-168
    Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.
  • Drug: 123-I MNI-168
    Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.
  • Experimental: I 123-MNI-168
    Interventions:
    • Drug: I-123-MNI-168
    • Drug: 123-I MNI-168
  • Experimental: I123 MNI168
    brain imaging using I123MNI168
    Interventions:
    • Drug: I-123-MNI-168
    • Drug: 123-I MNI-168
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
January 2011
January 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00870519
MNI-168-01
No
Danna Jennings M.D., Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
Not Provided
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
Institute for Neurodegenerative Disorders
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP