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

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MNI-330 as a brain SPECT tracer of Beta-Amyloid
Sponsored by
Institute for Neurodegenerative Disorders
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer, SPECT

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute for Neurodegenerative Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Access [123I]MNI-330 and SPECT Imaging

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
April 8, 2008
Last Updated
April 1, 2019
Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Molecular NeuroImaging
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1. Study Identification

Unique Protocol Identification Number
NCT00657813
Brief Title
Evaluation of [123I] MNI-330 and SPECT as a Marker of Beta-amyloid Protein Deposition
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Data did not evidence [123I]MNI-330 as a useful tool in the detection of AD.
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 30, 2008 (Actual)
Study Completion Date
September 30, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Neurodegenerative Disorders
Collaborators
Molecular NeuroImaging

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer, SPECT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Access [123I]MNI-330 and SPECT Imaging
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MNI-330 as a brain SPECT tracer of Beta-Amyloid
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danna Jennings, MD
Organizational Affiliation
Institute for Neurodegenerative Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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