search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[123I] 5-IA
Sponsored by
Institute for Neurodegenerative Disorders
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease focused on measuring Parkinson, imaging, nicotinic receptors

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The presence of idiopathic Parkinson disease
  • A clear clinical response to dopaminergic therapy treatment
  • Hoehn and Yahr Stages < 3;
  • 2-7 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Institute for Neurodegenerative Disorders

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[123I] 5-IA

Arm Description

To assess [123I] 5IA and SPECT imaging

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

Nicotinic receptor as a reliable measure
Is [123I] 5-IA a reliable measure of nicotinic receptors in Parkinson Disease?

Full Information

First Posted
November 7, 2006
Last Updated
April 16, 2014
Sponsor
Institute for Neurodegenerative Disorders
Collaborators
United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT00397696
Brief Title
Evaluation of 5-[123I]-A-85380 and SPECT Imaging in Individuals With Parkinsons Disease
Official Title
Evaluation of 5-[123I]-A-85380 and SPECT Imaging as a Marker of Nicotinic Receptor Density in the Brain of Parkinson Disease Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for Neurodegenerative Disorders
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. The primary imaging outcome measure will be VT', the equilibrium distribution volume in brain regions is determined from an MRI-directed region-of-interest (ROI) analysis. The baseline imaging VT' will be compared to the follow-up imaging study to the reliability of the nicotinic [123I] 5-IA imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson, imaging, nicotinic receptors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[123I] 5-IA
Arm Type
Experimental
Arm Description
To assess [123I] 5IA and SPECT imaging
Intervention Type
Drug
Intervention Name(s)
[123I] 5-IA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Radiotracer uptake in cortical regions in PD relative to Healthy Control subjects
Description
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?
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Nicotinic receptor as a reliable measure
Description
Is [123I] 5-IA a reliable measure of nicotinic receptors in Parkinson Disease?
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The presence of idiopathic Parkinson disease A clear clinical response to dopaminergic therapy treatment Hoehn and Yahr Stages < 3; 2-7 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Seibyl, 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

Citations:
PubMed Identifier
6927555
Citation
Pirozzolo FJ, Hansch EC, Mortimer JA, Webster DD, Kuskowski MA. Dementia in Parkinson disease: a neuropsychological analysis. Brain Cogn. 1982 Jan;1(1):71-83. doi: 10.1016/0278-2626(82)90007-0.
Results Reference
background
PubMed Identifier
6067254
Citation
Hoehn MM, Yahr MD. Parkinsonism: onset, progression and mortality. Neurology. 1967 May;17(5):427-42. doi: 10.1212/wnl.17.5.427. No abstract available.
Results Reference
background
PubMed Identifier
7574455
Citation
Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, van Dyck C, et al. Decreased single-photon emission computed tomographic [123I]beta-CIT striatal uptake correlates with symptom severity in Parkinson's disease. Ann Neurol. 1995 Oct;38(4):589-98. doi: 10.1002/ana.410380407. Erratum In: Ann Neurol. 1996 Mar;39(3):417. van Dyck, C [added].
Results Reference
background
PubMed Identifier
12756643
Citation
Seibyl JP. Imaging studies in movement disorders. Semin Nucl Med. 2003 Apr;33(2):105-13. doi: 10.1053/snuc.2003.127303.
Results Reference
background
PubMed Identifier
12442677
Citation
Marek K, Jennings D, Seibyl J. Single-photon emission tomography and dopamine transporter imaging in Parkinson's disease. Adv Neurol. 2003;91:183-91. No abstract available.
Results Reference
background
PubMed Identifier
12666107
Citation
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.
Results Reference
background
PubMed Identifier
9886673
Citation
Louis M, Clarke PB. Effect of ventral tegmental 6-hydroxydopamine lesions on the locomotor stimulant action of nicotine in rats. Neuropharmacology. 1998 Dec;37(12):1503-13. doi: 10.1016/s0028-3908(98)00151-8.
Results Reference
background
PubMed Identifier
12932857
Citation
Parain K, Hapdey C, Rousselet E, Marchand V, Dumery B, Hirsch EC. Cigarette smoke and nicotine protect dopaminergic neurons against the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine Parkinsonian toxin. Brain Res. 2003 Sep 12;984(1-2):224-32. doi: 10.1016/s0006-8993(03)03195-0.
Results Reference
background
PubMed Identifier
12769612
Citation
O'Neill MJ, Murray TK, Lakics V, Visanji NP, Duty S. The role of neuronal nicotinic acetylcholine receptors in acute and chronic neurodegeneration. Curr Drug Targets CNS Neurol Disord. 2002 Aug;1(4):399-411. doi: 10.2174/1568007023339166.
Results Reference
background
PubMed Identifier
12637374
Citation
Gale C, Martyn C. Tobacco, coffee, and Parkinson's disease. BMJ. 2003 Mar 15;326(7389):561-2. doi: 10.1136/bmj.326.7389.561. No abstract available. Erratum In: BMJ. 2003 Mar 22;326(7390):614. Gale, Chris [corrected to Gale, Catharine].
Results Reference
background
PubMed Identifier
12428730
Citation
Quik M, Kulak JM. Nicotine and nicotinic receptors; relevance to Parkinson's disease. Neurotoxicology. 2002 Oct;23(4-5):581-94. doi: 10.1016/s0161-813x(02)00036-0.
Results Reference
background
PubMed Identifier
11999458
Citation
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.
Results Reference
background
PubMed Identifier
11772120
Citation
Ross GW, Petrovitch H. Current evidence for neuroprotective effects of nicotine and caffeine against Parkinson's disease. Drugs Aging. 2001;18(11):797-806. doi: 10.2165/00002512-200118110-00001.
Results Reference
background
PubMed Identifier
10857708
Citation
Kelton MC, Kahn HJ, Conrath CL, Newhouse PA. The effects of nicotine on Parkinson's disease. Brain Cogn. 2000 Jun-Aug;43(1-3):274-82.
Results Reference
background
PubMed Identifier
1729398
Citation
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.
Results Reference
background
PubMed Identifier
11182569
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs