Assess 123-I IMPY and SPECT Imaging as a Tool to Detect β-Amyloid in the Brain

March 6, 2014 updated by: Danna Jennings, MD, Institute for Neurodegenerative Disorders

Evaluation of [123I] IMPY and SPECT as a Marker of Beta-amyloid Protein Deposition in the Brain of Healthy Subjects and Patients With Alzheimer Disease

This research is designed to obtain efficacy and safety information for 123-I IMPY as an imaging biomarker for Alzheimer's disease (AD). The distribution of this agent will be measured by obtaining single photon emission computed tomography (SPECT) images of the brain serially over time to determine the relative localization of the radiopharmaceutical in regions of the cortex relative to background regions and develop an optimal technique of radiotracer administration (bolus or bolus with constant infusion). The researchers will then evaluate the utility of 123-I IMPY and SPECT in AD patients as an early diagnostic tool and subsequently serial evaluations of AD patients will be performed to determine if this technique may be useful as a tool for evaluation of progressive brain β-amyloid deposition in AD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImanging (MNI) in New Haven, CT. Approximately 25 patients with mild to moderate Alzheimer's disease (AD) and 20 healthy controls will be recruited to participate in this study. AD patients will be eligible to participate if they have a diagnosis of AD of less than 3 years duration. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo either a bolus injection or bolus injection followed by continuous infusion of 123-I IMPY. Following injection, subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I IMPY in plasma (both protein bound and free) over a 3.5 - 8 hour period. 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 IMPY.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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/ADRA) criteria.
  • Mini-Mental Status Exam score > 16 and < 25.
  • Patients have a diagnosis of probable AD for < 3 years prior to screening.

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.
  • Subjects with an iodine allergy.
  • The subject has a clinically significant clinical laboratory value and/or 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 thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder.
  • The subject has received an investigational drug within 60 days before the screening visit.
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assess [123I] IMPY & SPECT Imaging
To assess [123I] IMPY & SPECT Imaging
Drug: [123I] IMPY & SPECT Imaging
Subjects will be injected with 7mCi of [123I]IMPY, followed by SPECT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Does 123-I IMPY demonstrate qualitatively increased radiotracer uptake in cortical regions consistent with β-amyloid deposition in AD patients relative to controls
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Can 123-I IMPY and SPECT provide a quantitative and reproducible measure of amyloid deposition
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Neurodegenerative Disorders

Collaborators

Alzheimer's Association
Molecular NeuroImaging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

February 2, 2006

First Submitted That Met QC Criteria

February 2, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMYLOID001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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