Not Signed In -
Wolff-Parkinson-White Syndrome |
WPW |
Clinical Trial: Imaging and Genetic Biomarkers of Parkinson Disease (PD) Onset and Progression in High-Risk Families
This study is not yet open for patient recruitment.
Verified by Institute for Neurodegenerative Disorders January 2006
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Parkinson Disease Parkinsonian Syndrome | Drug: [123I]β CIT and SPECT imaging Device: ANAM computerized testing Procedure: UPSIT (standardized smell test) | Phase II |
MedlinePlus related topics: Brain Diseases; Movement Disorders; Parkinson''''s Disease
Genetics Home Reference related topics: Parkinson disease
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Assessment of Pre-Symptomatic and Symptomatic Patients With Parkinson Disease to Identify and Characterize Genetic and Phenotypic Biomarkers for Disease Onset and Progression.
Secondary Outcomes: correlation of the imaging outcome with both clinical outcomes (olfaction, reaction time, handwriting, etc) and biochemical measures
Expected Total Enrollment: 50
Study start: January 2005; Expected completion: December 2010
Last follow-up: July 2010; Data entry closure: October 2010
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.
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:
Location and Contact Information
Connecticut
Institute for Neurodegenerative Disorders, New Haven, Connecticut, 06510, United States
Kenneth L. Marek, MD, Principal Investigator, President and Senior Scientist
More Information
Publications
Autere JM, Hiltunen MJ, Mannermaa AJ, Jakala 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.
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.
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.
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.
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. No abstract available.
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.
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.
Seibyl JP, Marek KL, Quinlan D, Sheff K, Zoghbi S, Zea-Ponce Y, Baldwin RM, Fussell B, Smith EO, Charney DS, 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.
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.
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.
Last Updated: January 6, 2006
Record first received: January 4, 2006
ClinicalTrials.gov Identifier: NCT00273351
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Wolff-Parkinson-White Syndrome (Cleveland Clinic)
- Wolff-Parkinson-White syndrome (Google Health)
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