Status:
COMPLETED
Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls
Lead Sponsor:
Institute for Neurodegenerative Disorders
Conditions:
Parkinson Disease
Alzheimer Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
The underlying goal of this study is to assess \[18F\] CFPyPB PET imaging as a tool to evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer Disease (AD) ...
Detailed Description
Approximately 6 subjects with Parkinson disease, 6 subjects with Alzheimer disease and 20 healthy control subjects will be recruited to participate in this study. All subjects will undergo written inf...
Eligibility Criteria
Inclusion
- PD subject inclusion criteria:
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria).
- Modified Hoehn and Yahr stage of 1 - 4.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \[18F\] CFPyPB injection.
- PD subject exclusion criteria:
- 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.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The subject has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
- The subject is a pregnant or nursing mother
- AD subject inclusion criteria:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of probable Alzheimer disease in accordance with the DSM-IV-TR and according to (NINCDS/ADRDA) criteria.
- Participants do not fulfill the ICC criteria for probable DLB, the NINDS-AIREN for probable vascular dementia, or the Neary \[Neary, et al. 1998\] criteria for FTD.
- Clinical Dementia Rating Scale score 0.5, 1 or 2.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- Geriatric Depression Scale (GDS) ≤ 10.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of \[18F\] CFPyPB injection.
- AD subject exclusion criteria:
- 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.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The subject has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
- The subject is a pregnant or nursing mother.
- Healthy volunteer inclusion criteria:
- 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 a negative urine or blood pregnancy test on day of \[18F\] CFPyPB injection.
- Healthy volunteer exclusion criteria:
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- The subject has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
- The subject is a pregnant or nursing mother.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01461109
Start Date
August 1 2011
End Date
May 1 2014
Last Update
June 4 2014
Active Locations (1)
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1
Institute_Neurodegenerative_Disorders
New Haven, Connecticut, United States, 06510