跳至主要内容
临床试验/NCT00024622
NCT00024622
已完成
不适用

Positron Emission Tomography (PET) Scanning in Dopamine Disorders: Parkinson's Disease and Schizophrenia

National Institute of Mental Health (NIMH)1 个研究点 分布在 1 个国家目标入组 502 人2002年3月15日

概览

阶段
不适用
干预措施
18F-Fluoro-L-dopa
疾病 / 适应症
Schizophrenia
发起方
National Institute of Mental Health (NIMH)
入组人数
502
试验地点
1
主要终点
To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.
状态
已完成
最后更新
3天前

概览

简要总结

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....

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2002年3月15日
结束日期
待定
最后更新
3天前
研究类型
Observational
性别
All

研究者

入排标准

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Patients - schizophrenia spectrum disorders

Patients - schizophrenia spectrum disorders

干预措施: 18F-Fluoro-L-dopa

Healthy volunteers

Healthy volunteers.

干预措施: O-15 Water

Patients - Parkinsons

Patients with Parkinsons

干预措施: 18F-Fluoro-L-dopa

Patients - schizophrenia spectrum disorders

Patients - schizophrenia spectrum disorders

干预措施: O-15 Water

Patients - Parkinsons

Patients with Parkinsons

干预措施: O-15 Water

结局指标

主要结局

To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.

时间窗: Ongoing

To explore with positron emission tomography (PET) the pathophysiology and cerebral consequences of dopaminergic dysregulation.

研究点 (1)

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