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PET Scanning in Parkinson s Disease

This study is currently recruiting participants.
Verified September 27, 2017 by National Institutes of Health Clinical Center (CC)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00024622
First Posted: September 24, 2001
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.

Condition
Parkinson's Disease

Study Type: Observational
Official Title: Positron Emission Tomography (PET) Scanning in Dopamine Disorders: Parkinson's Disease and Schizophrenia

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 460
Study Start Date: September 17, 2001
Detailed Description:
This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Age between 18 and 90 years
  • Ability to give informed consent
  • Ability to read and write
  • Ability to give adequate medical and neuropsychiatric history.

PARKINSONS DISEASE:

  • Individuals over the age of 18 from families in which an autosomal dominant form of Parkinson's disease is suspected based on pedigree analysis.
  • Each subject will have a medical history and brief neurological examination.
  • The diagnosis in probands must be supported by accepted clinical criteria: tremor, bradykinesia, and responsiveness to L-DOPA.
  • Equivocally affected individuals will also be included in order to aid in their phenotypic classification as will at risk individuals who show no neurological signs.
  • Individuals with sporadic Parkinson's disease will also be scanned. These will be over the age of 50 years and will have no known family history of Parkinson's disease or any other movement disorder.
  • PD patients will have an admission physical exam and medical history as well as laboratory tests deemed necessary on the basis of history and physical exam.

SCHIZOPHRENIA:

- Members of this patient group will have a diagnosis of schizophrenia or schizophrenia spectrum disorder as determined by the SCID and will be currently enrolled in NIH approved protocol 89-M-0160 (Inpatient Evaluation of Neuropsychiatric Patients) under which they will have received admission work-up.

HEALTHY VOLUNTEERS:

  • A large cohort of healthy volunteers will also have a PET scan.
  • Volunteers will be age, gender and handedness-matched to patients for statistical purposes.
  • Volunteers, who are enrolled as healthy controls under protocol 95-M-0150 "Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and their Siblings" will receive admission workup through that protocol.

EXCLUSION CRITERIA:

  • Will include medical illness that would affect cerebral blood flow or dopamine
  • Current pregnancy
  • Current breast feeding
  • Possible exposure to radiation exceeding RSC guidelines
  • History of any (excepting nicotinerelated) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
  • Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse),either in excess of 5 years total or not in remission for at least 6 months,
  • Inability to stay caffeine- and nicotine-free for 4 hours
  • Current suicidality or assaultiveness
  • History of movement disorder
  • History of head injury requiring hospitalization
  • History of coma
  • Inability to meet general safety criteria for MRI study (as determined by standardized Nuclear Medicine Research (NMR) Center screening)
  • Previously demonstrated inability or unwillingness to comply with a study protocol.

PARKINSONS DISEASE:

- Individuals not capable of understanding the consent will be excluded.

HEALTHY VOLUNTEERS:

- Healthy volunteers will be unable to participate if they have been treated with psychotropic medication within the three months prior to scanning, are undergoing current psychiatric treatment, have any history of major psychiatric or movement disorder, have a first degree relative with schizophrenia, or have a family history of PD.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024622


Contacts
Contact: Jasmin Czarapata, Ph.D. (301) 435-7645 js733c@nih.gov
Contact: Karen F Berman, M.D. (301) 496-7603 bermank@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Karen F Berman, M.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00024622     History of Changes
Other Study ID Numbers: 010232
01-M-0232
First Submitted: September 23, 2001
First Posted: September 24, 2001
Last Update Posted: October 12, 2017
Last Verified: September 27, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Familial
Genetic
Symptomatic
Equivocally Affected
18F-Fluoro-L-dopa
O-15 Labelled Water
Carbidopa
Adult
Schizophrenia
Parkinson's Disease
PD
Parkinson
Healthy Control
HV
Normal Control

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases