Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease

NCT00397696 | Completed Phase 2 DMC

• 1 other identifier: 5-IA02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The underlying goal of this study is to assess \[123I\] 5-IA and SPECT imaging as a tool to detect nicotinic receptor activity in the brain of PD patients. 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 a diagnosis of PD without cognitive changes will be recruited to participate in this study. Patients will be eligible to participate if they have a diagnosis of PD of more than 2 years duration and have no significant cognitive changes.

Conditions

Parkinson Disease

Keywords

Parkinson; imaging; nicotinic receptors

Outcome Measures

Primary Outcomes (1)

• Radiotracer uptake in cortical regions in PD relative to Healthy Control subjects

  Does \[123I\] 5-IA demonstrate qualitatively decreased radiotracer uptake in cortical regions consistent with a reduction in nicotinic receptor density in PD patients relative to controls?

  2 years

Secondary Outcomes (1)

• Nicotinic receptor as a reliable measure

  2 years

Study Arms (1)

[123I] 5-IA

EXPERIMENTAL

To assess \[123I\] 5IA and SPECT imaging

Drug: [123I] 5-IA

Interventions

[123I] 5-IA DRUG

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 using the MMSE, the ANAM computerized cognitive battery, and other tests of executive function. All subjects will be evaluated with United Parkinson Disease Rating Scales (UPDRS) following an overnight withdrawal of anti-parkinson medication. Subjects will be asked to undergo an injection of \[123I\] 5-IA followed by SPECT imaging as described below. A second \[123I\] 5-IA and SPECT imaging study will be obtained for reliability testing between 2 weeks and 2 months following the initial \[123I\] 5IA imaging session.

[123I] 5-IA

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The presence of idiopathic Parkinson disease
• A clear clinical response to dopaminergic therapy treatment
• Hoehn and Yahr Stages \< 3;
• year Duration from time of diagnosis.
• Mini-mental status exam score of \>24,
• For females, non-child bearing potential or negative urine pregnancy test on day of \[123I\] 5-IA injection.

You may not qualify if:

• Secondary Parkinsonism;
• Nicotine dependence or use within the previous 12 months prior to enrollment;
• Treatment with Aricept (donepezil), Exelon (rivastigmine), Cognex (tacrine) within the past 30 days; treatment with medications that bind to the nicotinic receptor.
• Clinically significant clinical laboratory value and/or medical or psychiatric illness;
• Mini-mental status exam score of ≤24.
• 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 30 days of the screening visit;
• Pregnancy

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead
• United States Department of Defense: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Publications (16)

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  PMID: 12442677 BACKGROUND

• Marek K, Jennings D, Seibyl J. Dopamine agonists and Parkinson's disease progression: what can we learn from neuroimaging studies. Ann Neurol. 2003;53 Suppl 3:S160-6; discussion S166-9. doi: 10.1002/ana.10486. No abstract available.

  PMID: 12666107 BACKGROUND

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  PMID: 9886673 BACKGROUND

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  PMID: 12932857 BACKGROUND

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  PMID: 12769612 BACKGROUND

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• Mitsuoka T, Kaseda Y, Yamashita H, Kohriyama T, Kawakami H, Nakamura S, Yamamura Y. Effects of nicotine chewing gum on UPDRS score and P300 in early-onset parkinsonism. Hiroshima J Med Sci. 2002 Mar;51(1):33-9.

  PMID: 11999458 BACKGROUND

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• Aubert I, Araujo DM, Cecyre D, Robitaille Y, Gauthier S, Quirion R. Comparative alterations of nicotinic and muscarinic binding sites in Alzheimer's and Parkinson's diseases. J Neurochem. 1992 Feb;58(2):529-41. doi: 10.1111/j.1471-4159.1992.tb09752.x.

  PMID: 1729398 BACKGROUND

• Zoghbi SS, Tamagnan G, Fujita M, Baldwin RM, Al-Tikriti MS, Amici L, Seibyl JP, Innis RB. Measurement of plasma metabolites of (S)-5-[123I]iodo-3-(2-azetidinylmethoxy)pyridine (5-IA-85380), a nicotinic acetylcholine receptor imaging agent, in nonhuman primates. Nucl Med Biol. 2001 Jan;28(1):91-96. doi: 10.1016/S0969-8051(00)00188-8.

  PMID: 11182569 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Iodine-123

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• John Seibyl, MD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: November 7, 2006
• First Posted: November 9, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 7, 2014

Record last verified: 2014-04

Locations

US (1)