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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Institute for Neurodegenerative Disorders
Sponsor:
Information provided by (Responsible Party):
David Russell, MD, PhD, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier:
NCT00870974
First received: March 26, 2009
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Huntington Disease
Autistic Spectrum Disorders
Fragile X Syndrome
Alzheimer Disease
Mild Cognitive Impairment
Drug: [18F]FPEB
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions

Resource links provided by NLM:


Further study details as provided by Institute for Neurodegenerative Disorders:

Primary Outcome Measures:
  • Does FPEB reliably represent the known distribution of MGLUR5 in the brain? [ Time Frame: at completion of scans ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 155
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Assess [18F]FPEB and PET imaging
To assess [18F] FPEB and PET imaging in subjects with neuropsychiatric conditions.
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
Other Name: Fluorine-18

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00870974

Contacts
Contact: Debbie Stottle 203-401-4300 info@indd.org

Locations
United States, Connecticut
Institute for Neurodegenerative Disorders Recruiting
New Haven, Connecticut, United States, 06510
Contact: Debbie Stottle    203-401-4300    info@indd.org   
Principal Investigator: David Russell, MD,PhD         
Sub-Investigator: Danna Jennings, MD         
Sponsors and Collaborators
Institute for Neurodegenerative Disorders
Investigators
Principal Investigator: David Russell, MD Institute for Neurodegenerative Disorders
  More Information

No publications provided

Responsible Party: David Russell, MD, PhD, Principal Investigator, Institute for Neurodegenerative Disorders
ClinicalTrials.gov Identifier: NCT00870974     History of Changes
Other Study ID Numbers: FPEB
Study First Received: March 26, 2009
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Institute for Neurodegenerative Disorders:
Parkinson
Huntington's
Fragile X
Autistic Spectrum
Alzheimer's
MCI

Additional relevant MeSH terms:
Fragile X Syndrome
Mental Retardation, X-Linked
Genetic Diseases, X-Linked
Alzheimer Disease
Autistic Disorder
Huntington Disease
Parkinson Disease
Cognition Disorders
Child Development Disorders, Pervasive
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Basal Ganglia Diseases
Chorea
Dyskinesias
Movement Disorders

ClinicalTrials.gov processed this record on July 20, 2014