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

NCT00287248 | Completed Phase 1

• 1 other identifier: AMYLOID001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer; Alzheimer disease; Alzheimer disease (AD)

Outcome Measures

Primary Outcomes (1)

• Does 123-I IMPY demonstrate qualitatively increased radiotracer uptake in cortical regions consistent with β-amyloid deposition in AD patients relative to controls

  2 years

Secondary Outcomes (1)

• Can 123-I IMPY and SPECT provide a quantitative and reproducible measure of amyloid deposition

  2 years

Study Arms (1)

Assess [123I] IMPY & SPECT Imaging

EXPERIMENTAL

To assess \[123I\] IMPY \& SPECT Imaging

Drug: [123I] IMPY & SPECT Imaging

Interventions

[123I] IMPY & SPECT Imaging DRUG

Subjects will be injected with 7mCi of \[123I\]IMPY, followed by SPECT imaging

Assess [123I] IMPY & SPECT Imaging

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• Alzheimer's Association: collaborator
• Molecular NeuroImaging: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

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MeSH Terms

Conditions

Alzheimer Disease

Interventions

Iodine-123; 2,3-dihydro-1H-imidazo(1,2-b)pyrazole

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Danna L Jennings, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 7, 2014

Record last verified: 2014-03

Locations

US (1)