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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: I-123-MNI-168
Drug: 123-I MNI-168
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To acquire initial safety data following injection of (123I) MNI-168. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: January 2009
Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I 123-MNI-168 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: I123 MNI168
brain imaging using I123MNI168
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.

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870519

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: Danna Jennings, MD Institute for Neurodegenerative Disorders
  More Information

No publications provided

Responsible Party: Danna Jennings M.D., Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00870519     History of Changes
Other Study ID Numbers: MNI-168-01
Study First Received: March 26, 2009
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Alzheimer disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014