A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions

Parkinson Disease Clinical Trial

— FPEB  

Official title:

Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870974
• Other study ID #: FPEB
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2009
• Last updated: January 5, 2017
• Start date: March 2009
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Institute for Neurodegenerative Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Measurement of metabotropic glutamate receptor type 5 (mGluR5) binding capacity in the brain, may be a valuable tool in the early detection, understanding, or evaluation of Parkinson disease (PD), Huntington disease (HD), Fragile X syndrome (FXS), Autism Spectrum Disorder(ASD), Alzheimer's Disease(AD), and subjects with mild cognitive impairment (MCI).

The goal of this study is to assess [18F]F-PEB positron emission tomography (PET) imaging as a tool to detect mGluR5 density in the brain of PD, HD, FXS ASD, AD, and MCI research participants and similarly aged healthy subjects.

Description:

Informed consent will be obtained for all subjects. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. All subjects will undergo [18F]F-PEB PET imaging. Subjects may also be asked to undergo standard brain MRI to assist in the analysis of the PET images obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Written informed consent must be obtained For all females of child-bearing potential, a negative urine or blood pregnancy test on day of [18F]PEB injection.

INCLUSION CRITERIA:

PD subjects:

• Age 30 years or older.

• Clinical diagnosis of PD with at least two of three of the cardinal symptoms of PD (rest tremor, rigidity, bradykinesia)

• Hoehn and Yahr[35] = 4.

HD subjects:

• Age 18 years or older.

• Participants have a clinical diagnosis of symptomatic HD with genetic confirmation

• Subject is able to provide informed consent as judged by the investigator, or assent can be obtained from the subject and informed consent provided by the appropriate legal representative or next of kin.

Healthy volunteers should be 18 years of age or older and have a negative history of neurological or psychiatric illness.

ASD and/or FRAGILE X:

• Age 18 years or older

• Clinical diagnosis of ASD and/or FXS

• Diagnosis of FXS based on gene testing or diagnosis of ASD based on DSM-IV criteria

AD subjects:

• Participants have a positive assessment for dementia of Alzheimer type in accordance with the DSM-IV-TR and probable AD according to the NINCDS-ADRDA criteria.

• Participants do not fulfill the ICC criteria for probable DLB, the NINDS-AIREN for probable vascular dementia, or the Neary criteria for FTD.

• CDR score of 0.5, 1 or 2.

MCI subjects:

• Participants must have a complaint of memory loss, objective impairment in at least one cognitive domain, essentially preserved activities of daily living, and do not meet diagnostic criteria for AD or other form of dementia. Participants do not fulfill the ICC criteria for probable DLB, the NINDS-AIREN for probable vascular dementia, or the Neary criteria for FTD.

• CDR score of = 0.5.

AD and MCI:

• Age 50 years or older.

• MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease. Exclusion criterion may be waived if, in the judgment of the investigator (1) vascular dementia is clinically unlikely and (2) the subject is deemed unable to tolerate the MRI procedure due to claustrophobia, etc.

EXCLUSION CRITERIA:

PD, HD and ASD and/or Fragile X subjects:

• Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness

• Any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).

• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.

• Clinically significant evidence of vascular disease or alternative neurologic disorder

Healthy volunteers:

• Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.

• Any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).

• Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.

AD and MCI subjects:

• The subject has 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 (including significant gastrointestinal surgery).

• The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Alzheimer Disease
• Autism Spectrum Disorder
• Autistic Disorder
• Autistic Spectrum Disorders
• Child Development Disorders, Pervasive
• Cognition Disorders
• Fragile X Syndrome
• Huntington Disease
• Mild Cognitive Impairment
• Parkinson Disease

Intervention

Drug:
• [18F]FPEB
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]F-PEB

Locations

Country	Name	City	State
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Neurodegenerative Disorders

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does FPEB reliably represent the known distribution of MGLUR5 in the brain?		at completion of scans	Yes