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Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

Primary Purpose

Alzheimer's Disease

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

I-123-MNI-168

123-I MNI-168

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Alzheimer disease

Eligibility Criteria

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

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

Sites / Locations

Institute for Neurodegenerative Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

I 123-MNI-168

I123 MNI168

Arm Description

brain imaging using I123MNI168

Outcomes

Primary Outcome Measures

To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain,

Secondary Outcome Measures

To acquire initial safety data following injection of (123I) MNI-168.

Full Information

NCT ID

NCT00870519

First Posted

March 26, 2009

Last Updated

April 1, 2019

Sponsor

Institute for Neurodegenerative Disorders

1. Study Identification

Unique Protocol Identification Number

NCT00870519

Brief Title

Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Assessment of data shows inadequate brain uptake, suggesting the tracer is inadequate as an imaging biomarker of brain amyloid.

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute for Neurodegenerative Disorders

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Alzheimer's Disease

Keywords

Alzheimer disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

I 123-MNI-168

Arm Type

Experimental

Arm Title

I123 MNI168

Arm Type

Experimental

Arm Description

brain imaging using I123MNI168

Intervention Type

Drug

Intervention Name(s)

I-123-MNI-168

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

123-I MNI-168

Intervention Description

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.

Primary Outcome Measure Information:

Title

To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain,

Time Frame

1 year

Secondary Outcome Measure Information:

Title

To acquire initial safety data following injection of (123I) MNI-168.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

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

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Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

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