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Evaluation of [123I] MNI-308 and SPECT as a Marker of Beta-amyloid Protein Deposition in AD Subjects Compared to HC

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[123I] MNI-308
Sponsored by
Molecular NeuroImaging
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • 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 or blood pregnancy test on day of 123-I MNI-308 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 or blood pregnancy test on day of 123-I MNI-308 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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 12, 2007
Last Updated
August 20, 2009
Sponsor
Molecular NeuroImaging
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1. Study Identification

Unique Protocol Identification Number
NCT00544453
Brief Title
Evaluation of [123I] MNI-308 and SPECT as a Marker of Beta-amyloid Protein Deposition in AD Subjects Compared to HC
Official Title
Evaluation of [123I] MNI-308 and 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
August 2009
Overall Recruitment Status
Terminated
Why Stopped
Preliminary data showed [123I] MNI-308 not a useful tool in detection of AD.
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
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-308, 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-308 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-308 as a single photon computed tomography (SPECT) brain imaging agent Evaluate the test/retest reproducibility of 123-I MNI-308 and SPECT in AD subjects and healthy control
Detailed Description
General Design and Methods. The underlying goal of this study is to assess 123-I MNI-308 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. An interval of at least 14 days will lapse between dosing in the first four AD subjects. This is intended to provide a longer period for AE assessments. Once complete, absent any serious adverse events in these initial AD subjects, dosing may commence with the remainder of the subjects, including healthy controls. Informed consent will be obtained for all subjects. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo a bolus injection of 123-I MNI-308. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-308 in plasma (both protein bound and free) over a period of up to 8 hours. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. 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-308. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
[123I] MNI-308
Intervention Description
Injection of [123I] MNI-308 and SPECT scanning

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 or blood pregnancy test on day of 123-I MNI-308 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 or blood pregnancy test on day of 123-I MNI-308 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 L 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

Links:
URL
http://www.indd.org
Description
Related Info

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Evaluation of [123I] MNI-308 and SPECT as a Marker of Beta-amyloid Protein Deposition in AD Subjects Compared to HC

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