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View Clinical Trial (Medical Research Study)
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A Positron Emission Tomography (PET) Brain Imaging Study of Glutamate Receptor 5 in Parkinson and Huntington Diseases - NCT00870974-06510 (Clinical Trial 281018)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy281018.aspx
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| City: |
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New Haven |
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State:
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CT |
| Zip Code: |
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06510 |
| Conditions: |
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Parkinson Disease - Huntington Disease |
| Purpose: |
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Measurement of mGluR5 binding capacity in the brain, may be a valuable tool in the early
detection, understanding, or evaluation of Parkinson and Huntington diseases.
The goal of this study is to assess [18F]F-PEB PET imaging as a tool to detect mGluR5
density in the brain of PD and HD research participants and similarly age ed healthy
subjects.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:Parkinson Subject Selection. Subjects who have a clinical diagnosis of
PD will be recruited for this study. The following criteria will be met for inclusion of
PD subjects in this study:
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of Parkinson disease based on having at least
two of three of the cardinal symptoms of PD (rest tremor, rigidity, bradykinesia)
- Hoehn and Yahr[35] ≤ 4.
- For females, non-child bearing potential or negative urine or blood pregnancy test on
day of [18F]PEB injection.
Parkinson subjects will be excluded from participation for the following reasons:
- The subject has clinically significant abnormal laboratory value and/or clinically
significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption distribution,
metabolism, or excretion (including significant gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular,
hepatic, renal, hematological, neoplastic, endocrine, alternative neurological,
immunodeficiency, pulmonary, or other disorder or disease.
- Clinically significant evidence of vascular disease or alternative neurologic
disorder
- Pregnancy
- Huntington Disease Subject Selection. Subjects with a diagnosis of HD will be
recruited for this study. The following criteria will be met for inclusion of
HD subjects in this study:
- The participant is 18 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of symptomatic Huntington disease with genetic
confirmation
- Subject is able to provide informed consent as judged by the investigator, or assent
can be obtained from the subject and informed consent provided by the appropriate
legal representative or next of kin.
- For females of child-bearing potential, a negative urine or blood pregnancy test on
day of [18F]PEB injection.
Huntington disease subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically
significant unstable medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption distribution,
metabolism, or excretion (including significant gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular,
hepatic, renal, hematological, neoplastic, endocrine, alternative neurological,
immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
- Clinically significant evidence of vascular disease or alternative neurologic
disorder
Healthy Control Subject Selection. Healthy control subjects who have no neurological
disease will be recruited for this study. The following criteria will be met for inclusion
of healthy control subjects in this study:
- The participant is 18 years or older.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a
research physician.
- For females, non-child bearing potential or negative urine or blood pregnancy test on
day of [18F]PEB injection.
Healthy control subjects will be excluded from participation for the following reasons:
- The subject has a clinically significant abnormal laboratory value and/or clinically
significant unstable medical or psychiatric illness.
- The subject has any disorder that may interfere with drug absorption distribution,
metabolism, or excretion (including significant gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular,
hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency,
pulmonary, or other disorder or disease.
- Pregnancy |
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| Study is available at: |
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Institute for Neurodegenerative Disorders
New Haven, CT 06510
United States
Primary Contact:
Barbara A Fussell, RN
Email: bfussell@indd.org
Phone: 203-401-4345 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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