Evaluation of [123I] MNI-330 and SPECT as a Marker of Beta-amyloid Protein Deposition

This study has been terminated.
(Data did not evidence [123I]MNI-330 as a useful tool in the detection of AD.)
Sponsor:
Collaborator:
Molecular NeuroImaging
Information provided by:
Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00657813
First received: April 8, 2008
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

The main objectives of this proposal are as follows:

To assess the dynamic uptake and washout of 123-I MNI-330, 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-330 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-330 as a single photon computed tomography (SPECT) brain imaging agent

Evaluate the test/retest reproducibility of 123-I MNI-330 and SPECT in AD subjects and healthy controls


Condition Intervention Phase
Alzheimer Disease
Drug: MNI-330 as a brain SPECT tracer of Beta-Amyloid
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of [123I] MNI-330 and Single Photon Emission Computed Tomography (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:
  • 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-330. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: March 2008
Study Completion Date: July 2008
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Access [123I]MNI-330 and SPECT Imaging Drug: MNI-330 as a brain SPECT tracer of Beta-Amyloid
Each subject will receive a bolus injection targeted to be 5 miCi and not to exceed 5.5 mCi of MNI-330. Following injection serial dynamic imaging will be obtained over 8 hrs.

Detailed Description:

The underlying goal of this study is to assess 123-I MNI-330 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with Alzheimers disease (AD) and 6 healthy controls (within +/- 2 years) will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.

  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 < 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-330 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-330 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.
  • 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.
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657813

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

No publications provided

Responsible Party: Danna Jennings, MD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00657813     History of Changes
Other Study ID Numbers: MNI-330-01
Study First Received: April 8, 2008
Last Updated: October 7, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Alzheimer
SPECT

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 July 22, 2014