Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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) research participants.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Institute for Neurodegenerative Disorders

Criteria

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.