Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00273351
Other study ID # PROSPECT
Secondary ID
Status Completed
Phase Phase 2
First received January 4, 2006
Last updated April 21, 2014
Start date January 2006
Est. completion date January 2008

Study information

Verified date April 2014
Source Institute for Neurodegenerative Disorders
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by rigidity, bradykinesia, postural instability, and tremor. Clinical decline reflects ongoing degeneration of dopamine-containing neurons. A critical unmet need for clinical research is to improve early detection of these diseases by developing tools to assist with earlier diagnosis. Biomarkers are broadly defined as characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (Biomarkers Defintions Working Group 2001). Development of reliable biomarkers for PD would dramatically accelerate research on PD etiology, pathophysiology, disease progression and therapeutics. Specific biomarkers may be useful at the onset of neurodegeneration, the onset of disease, and/or to mark disease progression. The biomarkers in this study include brain imaging with a radioactively labelled drug (Beta-CIT), computerized testing of memory, attention, motor speed, judgment and handwriting, and assessments of speech and smell. Subjects may also be asked to provide a blood sample for genetic and biochemical testing.


Description:

Individuals who agree to participate in this trial will have a complete screening exam by a neurologist at the Institute for Neurodegenerative Disorders (IND) in New Haven, CT. The exam may include blood tests, urine tests and an electrocardiogram (ECG -tracing of the electrical activity of the heart) to determine eligibility for the trial.

Research subjects will participate in a variety of biomarker assessments including brain imaging, which will take place over a period of two days.

On the first day subjects report to IND after a brief exam subjects will receive a standard dose of Lugol's solution (potassium iodide) by mouth to decrease uptake of the radioactive drug into the thyroid gland. Subjects will be given a standard dose of potassium perchlorate if allergic to iodine.

Next subjects will receive the intravenous (IV - into a vein) injection of the Beta-CIT, a radioactive material that localizes in the brain.

On the second day, about 24 hours after the injection, subjects will return to IND for a SPECT scan. The SPECT camera takes a "picture" of the radiation emitted by the Beta-CIT. This procedure will take approximately 30 minutes.

Subjects will be contacted by phone one week following the injection to monitor adverse (bad or harmful) events possibly related to the imaging procedure.

This two-day imaging procedure, comprehensive neurological testing, and blood collection for genetics and biochemical testing may be repeated every 12 to 18 months during the next five years.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Age >21

- Previous participation in the Progeni or Core PD clinical study

- A diagnosis of parkinsonism or a family history of parkinsonism

- Normal screening laboratory studies including:

- complete blood count

- chemistries

- urinalysis

Exclusion Criteria:

- Pregnancy

- Psychiatric disease other than history of depression

- Significant medical disease including abnormalities on screening biochemical or hematological labs or abnormal ECG.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
[123I]B-CIT
Subjects will receive up to 6 mCi of [123I] B-CIT injected intravenously

Locations

Country Name City State
United States Institute for Neurodegenerative Disorders New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Institute for Neurodegenerative Disorders Molecular NeuroImaging, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (16)

Autere JM, Hiltunen MJ, Mannermaa AJ, Jäkälä PA, Hartikainen PH, Majamaa K, Alafuzoff I, Soininen HS. Molecular genetic analysis of the alpha-synuclein and the parkin gene in Parkinson's disease in Finland. Eur J Neurol. 2002 Sep;9(5):479-83. — View Citation

Foroud T, Uniacke SK, Liu L, Pankratz N, Rudolph A, Halter C, Shults C, Marder K, Conneally PM, Nichols WC; Parkinson Study Group. Heterozygosity for a mutation in the parkin gene leads to later onset Parkinson disease. Neurology. 2003 Mar 11;60(5):796-801. — View Citation

Golbe LI, Di Iorio G, Sanges G, Lazzarini AM, La Sala S, Bonavita V, Duvoisin RC. Clinical genetic analysis of Parkinson's disease in the Contursi kindred. Ann Neurol. 1996 Nov;40(5):767-75. — View Citation

Kitada T, Asakawa S, Hattori N, Matsumine H, Yamamura Y, Minoshima S, Yokochi M, Mizuno Y, Shimizu N. Mutations in the parkin gene cause autosomal recessive juvenile parkinsonism. Nature. 1998 Apr 9;392(6676):605-8. — View Citation

Koller WC, Langston JW, Hubble JP, Irwin I, Zack M, Golbe L, Forno L, Ellenberg J, Kurland L, Ruttenber AJ, et al. Does a long preclinical period occur in Parkinson's disease? Neurology. 1991 May;41(5 Suppl 2):8-13. Review. — View Citation

Lincoln SJ, Maraganore DM, Lesnick TG, Bounds R, de Andrade M, Bower JH, Hardy JA, Farrer MJ. Parkin variants in North American Parkinson's disease: cases and controls. Mov Disord. 2003 Nov;18(11):1306-11. — View Citation

Marek, K., J. Seibyl, et al. (1996). "Dopamine transporter and receptor imaging in Parkinsonism. (Presented at the 4th International Congress of Movement Disorders, Vienna, Austria; June, 1996.)." Mov Dis 6.

Marek, K., J. Seibyl, et al. (1999). "[123I] ß-CIT/SPECT: Assessment of determinants of variability in progression of Parkinson's disease." Neurology 52: A91-92.

Polymeropoulos MH, Higgins JJ, Golbe LI, Johnson WG, Ide SE, Di Iorio G, Sanges G, Stenroos ES, Pho LT, Schaffer AA, Lazzarini AM, Nussbaum RL, Duvoisin RC. Mapping of a gene for Parkinson's disease to chromosome 4q21-q23. Science. 1996 Nov 15;274(5290):1197-9. — View Citation

Seibyl JP, Marek K, Sheff K, Baldwin RM, Zoghbi S, Zea-Ponce Y, Charney DS, van Dyck CH, Hoffer PB, Innis RB. Test/retest reproducibility of iodine-123-betaCIT SPECT brain measurement of dopamine transporters in Parkinson's patients. J Nucl Med. 1997 Sep;38(9):1453-9. — View 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. Erratum in: Ann Neurol. 1996 Mar;39(3):417. van Dyck, C [added]. — View Citation

Seibyl, J. P., K. L. Marek, et al. (1994). "[123I] B-CIT SPECT imaging in idiopathic parkinson's disease: correlation of striatal binding abnormality with disease severity [abstract]." Mov Disord 9(Suppl 1): 89.

Tanner, C. (1994). Epidemiologic clues to the cause of Parkinson's disease. Movement Disorders 3. S. Fahn and C. Marsden. Oxford, Butterworth-Heinemann: 124-146.

van Dyck CH, Seibyl JP, Malison RT, Laruelle M, Wallace E, Zoghbi SS, Zea-Ponce Y, Baldwin RM, Charney DS, Hoffer PB. Age-related decline in striatal dopamine transporter binding with iodine-123-beta-CITSPECT. J Nucl Med. 1995 Jul;36(7):1175-81. — View Citation

Vingerhoets FJ, Snow BJ, Lee CS, Schulzer M, Mak E, Calne DB. Longitudinal fluorodopa positron emission tomographic studies of the evolution of idiopathic parkinsonism. Ann Neurol. 1994 Nov;36(5):759-64. — View Citation

West AB, Maraganore D, Crook J, Lesnick T, Lockhart PJ, Wilkes KM, Kapatos G, Hardy JA, Farrer MJ. Functional association of the parkin gene promoter with idiopathic Parkinson's disease. Hum Mol Genet. 2002 Oct 15;11(22):2787-92. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Dopamine transporter density The dopamine transporter density in individuals at risk for Parkinsonism due to family history compared to healthy controls. 4.5 years No
Secondary Correlation of the imaging outcome with both clinical outcomes (olfaction, reaction time, handwriting, etc) and biochemical measures 4.5 years No
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A