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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00870974
• Date of registration: 26/03/2009
• Prospective Registration: No
• Primary sponsor: Institute for Neurodegenerative Disorders
• Public title: A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions FPEB
• Scientific title: Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions
• Date of first enrolment: March 2009
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00870974
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: David Russell, MD
• Affiliation: Institute for Neurodegenerative Disorders

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Autistic Spectrum Disorders

Alzheimer Disease

Huntington Disease

Fragile X Syndrome

Parkinson Disease

Mild Cognitive Impairment

Intervention(s)

Drug: [18F]FPEB

Primary Outcome(s)

Does FPEB reliably represent the known distribution of MGLUR5 in the brain? [Time Frame: at completion of scans]

Secondary ID(s)

FPEB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors