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Radioactive Drug

[123I]β-CIT for Parkinson's Disease

Phase 2

Waitlist Available

Led By David Russell, MD, PhD

Research Sponsored by Institute for Neurodegenerative Disorders

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new strategy to identify people at risk for Parkinson's disease before they show any symptoms. The strategy involves combining two biomarkers of parkinsonism, olfaction and brain imaging, with a radioactively labeled drug. First-degree relatives of PD patients will be recruited to participate in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Secondary outcome measures

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

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

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: [123I]β-CIT and SPECT imagingExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[123I]β-CIT

2006

Completed Phase 2

~230

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Find a Location

Who is running the clinical trial?

Institute for Neurodegenerative DisordersLead Sponsor

48 Previous Clinical Trials

10,014 Total Patients Enrolled

United States Department of DefenseFED

861 Previous Clinical Trials

224,194 Total Patients Enrolled

Molecular NeuroImagingOTHER

26 Previous Clinical Trials

1,940 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this clinical trial for new patients?

"Unfortunately, this particular study is not looking for any new patients right now. Although the listing on clinicaltrials.gov was last updated over 3 months ago, there are 517 other trials that might be a better match for you and your needs."

Answered by AI

What is the FDA's position on [123I]β-CIT?

"[123I]β-CIT is classified as a Phase 2 trial, meaning that while there is some evidence of its safety, none exists for its efficacy. Our team at Power rated [123I]β-CIT's safety with a 2."

Answered by AI

Recent research and studies

The Lancet NeurologyJournal

Challenges in Parkinson's Disease: Restoration of the Nigrostriatal Dopamine System Is Not Enough

Lang, Anthony E, and Jose A Obeso. 2004. “Challenges in Parkinson's Disease: Restoration of the Nigrostriatal Dopamine System Is Not Enough”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(04)00740-9.

Journal of Neurology, Neurosurgery & PsychiatryJournal

Measuring the Rate of Progression and Estimating the Preclinical Period of Parkinson's Disease with [18f]dopa PET

Morrish, P K, J S Rakshi, D L Bailey, G V Sawle, and D J Brooks. 1998. “Measuring the Rate of Progression and Estimating the Preclinical Period of Parkinson's Disease with [18f]dopa PET”. Journal of Neurology, Neurosurgery & Psychiatry. BMJ. doi:10.1136/jnnp.64.3.314.

Neurobiology of AgingJournal

Staging of Brain Pathology Related to Sporadic Parkinson’s Disease

Braak, Heiko, Kelly Del Tredici, Udo Rüb, Rob A.I de Vos, Ernst N.H Jansen Steur, and Eva Braak. 2003. “Staging of Brain Pathology Related to Sporadic Parkinson’s Disease”. Neurobiology of Aging. Elsevier BV. doi:10.1016/s0197-4580(02)00065-9.

ScienceJournal