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

This study has been terminated.
(Early Phase I study of [123I]MNI-340 did not evidence as marker of disease)
Sponsor:
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00968097
First received: April 25, 2008
Last updated: August 27, 2009
Last verified: August 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
 Drug: 123-I MNI-340
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of [123I] MNI-340 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:

U.S. FDA Resources

Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-340. [ Time Frame: 1 yr ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 123-I MNI-340
    To assess the dynamic uptake and washout of 123-I MNI-340, a potential imaging biomarker for β-amyloid burden in brain
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968097

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

No publications provided

Responsible Party: Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00968097     History of Changes
Other Study ID Numbers: MNI-340-01
Study First Received: April 25, 2008
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Alzheimer' disease
SPECT imaging

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 May 19, 2013