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

NCT01461109 | Completed Phase 1

• 1 other identifier: GlyT1-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Alzheimer Disease

Keywords

Parkinson Disease; Alzheimer Disease; [18F] CFPyPB; GlyT1

Outcome Measures

Primary Outcomes (1)

• To assess the dynamic uptake and washout of [18F] CFPyPB

  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).

  Approximately 2 years

Secondary Outcomes (3)

• Perform blood metabolite characterization of [18F] CFPyPB

  Approximately 2 years

• To obtain safety data

  Approximately 2 years

• Obtain test/retest reproductibility

  Approximately 2 years

Study Arms (1)

Assess [18F] CFPyPB and PET imaging

EXPERIMENTAL

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

Drug: [18F] CFPyPB

Interventions

[18F] CFPyPB 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).

Assess [18F] CFPyPB and PET imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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 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.

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Institute_Neurodegenerative_Disorders

New Haven, Connecticut, 06510, United States

Location

Related Links

• Institute for Neurodegenerative Disorders

MeSH Terms

Conditions

Parkinson Disease; Alzheimer Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders

Study Officials

• David Russell, MD, PhD

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: October 27, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: May 1, 2014
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

US (1)