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

NCT00870974 | Completed Phase 1

• 1 other identifier: FPEB
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Huntington Disease; Autistic Spectrum Disorders; Fragile X Syndrome; Alzheimer Disease; Mild Cognitive Impairment

Keywords

Parkinson; Huntington's; Fragile X; Autistic Spectrum; Alzheimer's; MCI

Outcome Measures

Primary Outcomes (1)

• Does FPEB reliably represent the known distribution of MGLUR5 in the brain?

  at completion of scans

Study Arms (1)

Assess [18F]FPEB and PET imaging

EXPERIMENTAL

To assess \[18F\] FPEB and PET imaging in subjects with neuropsychiatric conditions.

Drug: [18F]FPEB

Interventions

[18F]FPEB 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 \[18F\]F-PEB

Also known as: Fluorine-18

Assess [18F]FPEB and PET imaging

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute for Neurodegenerative Disorders: lead

Study Sites (1)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Huntington Disease; Autism Spectrum Disorder; Fragile X Syndrome; Alzheimer Disease; Cognitive Dysfunction

Interventions

Fluorine-18

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Chorea; Dyskinesias; Heredodegenerative Disorders, Nervous System; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Genetic Diseases, X-Linked; Tauopathies

Study Officials

• David Russell, MD

  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: March 26, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 6, 2017

Record last verified: 2017-01

Locations

US (1)