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

NCT ID: NCT01461109

Last Updated: 2014-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-05-31

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) research participants.

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 informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo a bolus injection of [18F] CFPyPB followed by serial PET imaging scans and plasma sampling for measurement of [18F] CFPyPB in plasma (both protein bound and free) over a period of up to 4 hours. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F] CFPyPB. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD and AD subjects will be compared with the HC subjects.

At least 2 weeks following the initial imaging visit subjects (up to 2 PD subjects, up to 2 AD subjects and up to 5 HC subjects) may be asked to return for a second injection and scanning procedure to evaluate the reproducibility of the imaging measure using this procedure. Subjects may decline participation in the second scan. Subjects will be requested to return for this second scan until enough second scan data is collected to evaluate the imaging outcome measure for reproducibility.

Conditions

Parkinson Disease; Alzheimer Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Assess [18F] CFPyPB and PET imaging

To assess \[18F\]CFPyPB and PET imaging

Group Type: EXPERIMENTAL

[18F] CFPyPB

Intervention Type: DRUG

Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of \[18F\]CFPyPB or 5 μg of CFPyPB (whichever is greatest).

Interventions

[18F] CFPyPB

Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of \[18F\]CFPyPB or 5 μg of CFPyPB (whichever is greatest).

Intervention Type: DRUG

Eligibility Criteria

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.

• 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.

• 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.

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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institute for Neurodegenerative Disorders

OTHER

Sponsor Role: lead

Responsible Party

David Russell, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Russell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Neurodegenerative Disorders

Locations

Institute_Neurodegenerative_Disorders

New Haven, Connecticut, United States

Countries

United States

Related Links

http://www.indd.org

Institute for Neurodegenerative Disorders

Other Identifiers

GlyT1-01

Identifier Type: -

Identifier Source: org_study_id