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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Russell, MD, PhD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT01461109
First received: September 27, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Alzheimer Disease
Drug: [18F] CFPyPB
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of [18F] CFPyPB PET as a Marker of Glycine Transporter-1 (GlyT1) Receptor in Subjects With Parkinson Disease, Alzheimer Disease and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • To assess the dynamic uptake and washout of [18F] CFPyPB [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
    To assess the dynamic uptake and washout of [18F] CFPyPB, an imaging tracer targeting the glycine transporter-1 (GlyT1) receptor in brain, using positron emission tomography (PET) in subjects with Parkinson disease (PD) Alzheimer disease (AD) and healthy controls (HC).


Secondary Outcome Measures:
  • Perform blood metabolite characterization of [18F] CFPyPB [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
    To perform blood metabolite characterization of [18F] CFPyPB in subjects with PD, AD and HC to determine the nature of metabolites in assessment of [18F] CFPyPB as a single positron computed tomography (PET) brain imaging agent.

  • To obtain safety data [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]
    To acquire safety data following injection of [18F] CFPyPB

  • Obtain test/retest reproductibility [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
    To obtain test/retest reproducibility of quantitative PET outcome measures with [18F] CFPyPB


Enrollment: 4
Study Start Date: August 2011
Study Completion Date: May 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assess [18F] CFPyPB and PET imaging
To assess [18F]CFPyPB and PET imaging
Drug: [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).
Other Name: [18F] CFPyPB

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461109

Locations
United States, Connecticut
Institute_Neurodegenerative_Disorders
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: David Russell, MD, PhD Institute for Neurodegenerative Disorders
  More Information

Additional Information:
No publications provided

Responsible Party: David Russell, MD, PhD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT01461109     History of Changes
Other Study ID Numbers: GlyT1-01
Study First Received: September 27, 2011
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Parkinson Disease
Alzheimer Disease
[18F] CFPyPB
GlyT1

Additional relevant MeSH terms:
Alzheimer Disease
Parkinson Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders

ClinicalTrials.gov processed this record on August 01, 2014