Brain Imaging Study in Subjects With Alzheimer Disease in... | NCT00870519

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

NCT00870519

Sponsor

Institute for Neurodegenerative Disorders

Status

Terminated

Last Update Posted

Apr 3, 2019Actual

Enrollment

2Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

I-123-MNI-168
123-I MNI-168

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Mar 26, 2009

First Posted Date

Mar 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2019

Last Update Posted Date

Apr 3, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I 123-MNI-168	Experimental		Drug: I-123-MNI-168 Drug: 123-I MNI-168
I123 MNI168	Experimental	brain imaging using I123MNI168	Drug: I-123-MNI-168 Drug: 123-I MNI-168

Interventions

Name	Type	Description	Arm Group Labels	Other Names
I-123-MNI-168	Drug	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.	I 123-MNI-168

Measure	Description	Time Frame
To assess the uptake and washout of {I123}MNI-168, a potential imaging biomarker for β-amyloid burden in brain,		1 year

Measure	Description	Time Frame
To acquire initial safety data following injection of (123I) MNI-168.		1 year

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases