A Study Evaluating Potential Screening Tools for Detecting Parkinson Disease

NCT00387075 | Unknown Phase 2

• 1 other identifier: PARS
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective cohort study to test the strategy of combining two biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug, \[123I\]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish an 'at risk' Parkinson disease cohort without motor symptoms of PD. First-degree relatives of PD will be recruited through PD research sites and national foundations to participate in this study. In addition, first degree relatives of PD patients will be recruited directly through advertising.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; SPECT imaging

Outcome Measures

Primary Outcomes (1)

• the mean striatal uptake of [123I]B-CIT in first-degree relatives with a loss of odor identification, compared to an established healthy control database (age 40-70; n=50)

  1 year

Secondary Outcomes (3)

• Estimate the frequency of olfactory loss of first-degree relatives of PD patients

  1 year

• Compare striatal DAT imaging in first-degree relatives of PD patients without signs or symptoms of PD with olfactory loss to age matched healthy controls

  1 year

• Determine if a reduction in DAT density using [123I]B-CIT and SPECT imaging in first-degree relatives of PD patients without signs or symptoms of PD at baseline predicts the onset of clinical PD at 2-year follow-up

  1 year

Study Arms (1)

[123I]β-CIT and SPECT imaging

EXPERIMENTAL

To Assess \[123I\]β-CIT and SPECT imaging

Procedure: [123I]β-CIT and SPECT imaging; Drug: [123I]β-CIT

Interventions

[123I]β-CIT and SPECT imaging PROCEDURE

This study is designed as a prospective cohort study to test the strategy of combining two biomarkers of parkinsonism, olfaction and brain imaging with a radioactively labeled drug, \[123I\]β-CIT , in a population of first-degree relatives of PD patients as a tool to establish an 'at risk' Parkinson disease cohort without motor symptoms of PD.

[123I]β-CIT and SPECT imaging

[123I]β-CIT DRUG

SPECT imaging uses the single photon emissions from radioactive compounds that are (most commonly) injected into a patient and are metabolized by specific organs or body systems. SPECT imaging is performed by using a gamma camera to acquire multiple 2-D images (also called projections),

[123I]β-CIT and SPECT imaging

Eligibility Criteria

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

You may qualify if:

• subject must have a first-degree relative with PD, based on their report
• subject must not carry a diagnosis of PD or other neurodegenerative disorder.
• subject must be either at least 50 yrs old or within 10 yrs of the age of onset of their affected relative
• Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus surgery)
• Subject must not be pregnant if participating in the imaging portion of this study
• Subject must not carry a diagnosis of PD or other neurodegenerative disorders
• Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus surgery)
• Subject must not be pregnant or be an actively nursing mother if participating in the imaging portion of this study.

You may not qualify if:

• diagnosis of PD or other neurodegenerative disorder
• other known reason for abnormal olfaction (e.g. nasal trauma, sinus infection, sinus surgery)
• pregnancy, if participating in the imaging portion of this study

Sponsors & Collaborators

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

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Related Publications (6)

• Morrish PK, Rakshi JS, Bailey DL, Sawle GV, Brooks DJ. Measuring the rate of progression and estimating the preclinical period of Parkinson's disease with [18F]dopa PET. J Neurol Neurosurg Psychiatry. 1998 Mar;64(3):314-9. doi: 10.1136/jnnp.64.3.314.

  PMID: 9527140 BACKGROUND

• Fearnley JM, Lees AJ. Ageing and Parkinson's disease: substantia nigra regional selectivity. Brain. 1991 Oct;114 ( Pt 5):2283-301. doi: 10.1093/brain/114.5.2283.

  PMID: 1933245 BACKGROUND

• DeKosky ST, Marek K. Looking backward to move forward: early detection of neurodegenerative disorders. Science. 2003 Oct 31;302(5646):830-4. doi: 10.1126/science.1090349.

  PMID: 14593169 BACKGROUND

• Braak H, Del Tredici K, Rub U, de Vos RA, Jansen Steur EN, Braak E. Staging of brain pathology related to sporadic Parkinson's disease. Neurobiol Aging. 2003 Mar-Apr;24(2):197-211. doi: 10.1016/s0197-4580(02)00065-9.

  PMID: 12498954 BACKGROUND

• Lang AE, Obeso JA. Challenges in Parkinson's disease: restoration of the nigrostriatal dopamine system is not enough. Lancet Neurol. 2004 May;3(5):309-16. doi: 10.1016/S1474-4422(04)00740-9.

  PMID: 15099546 BACKGROUND

• Brumm MC, Pierz KA, Lafontant DE, Caspell-Garcia C, Coffey CS, Siderowf A, Marek K. Updated Percentiles for the University of Pennsylvania Smell Identification Test in Adults 50 Years of Age and Older. Neurology. 2023 Apr 18;100(16):e1691-e1701. doi: 10.1212/WNL.0000000000207077. Epub 2023 Feb 27.

  PMID: 36849448 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• David Russell, MD, PhD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and Investigators were not provided results of the University of Pennsylvania Smell Identification Test (UPSIT).
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 29, 2022

Record last verified: 2019-04

Locations

US (1)