NCT06192823已完成不适用
Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Daily Kinesia ONE tremor one scores over a one-week medication washout
研究概览
简要总结
This study will evaluate the feasibility of adding objective measures (FDG-PET imaging, wearable biosensors) to a week-long washout protocol in early-stage Parkinson's disease patients. This study is also determining whether the washout can be conducted in the ambulatory setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*A clinical diagnosis of idiopathic PD. The diagnosis will be based upon the presence of at least two of the three cardinal motor signs of this disorder (akinesia/bradykinesia, rest tremor, and rigidity) with at least one of the signs being rest tremor or bradykinesia.
- •Clear and dramatic beneficial response to dopaminergic therapy (defined as demonstrating at least 30% improvement in parkinsonian motor signs based upon the UPDRS-III motor examination subscore, following the administration of their dopaminergic medications during the screening neurological examination)
- •*Hoehn and Yahr (H&Y) stage II when off medication.
- •Age between 50 and 75 years.
- •Subjects must be on dopaminergic therapy for at least one year prior to the screening visit and less than four years prior to the completion of the washout period.
- •Subjects must have a stable response to dopaminergic medication.
- •Available for follow-up for the entire duration of the study.
- •Subjects receiving antidepressant medication used specifically for the treatment of depression must be on stable doses for at least eight weeks prior to enrolling in the study.
- •Subjects must agree to maintain a stable regimen, if deemed medically appropriate by the treating physician, of any psychotropic medications throughout the study.
排除标准
- •*Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by:
- •Features unusual early in the clinical course (e.g., prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset)
- •Dementia preceding motor symptoms
- •Neurologic signs of upper motor neuron or cerebellar involvement
- •Significant orthostatic hypotension unrelated to medications
- •Unequivocal cortical sensory loss (i.e., graphesthesia, stereognosis with intact primary sensory modalities), clear limb ideomotor apraxia, or progressive aphasia
- •Vertical supranuclear gaze palsy, or selective slowing of vertical saccades
- •Unequivocal cerebellar abnormalities on examination, such as cerebellar gait, limb ataxia, or cerebellar oculomotor abnormalities (e.g., sustained gaze-evoked nystagmus, macro square wave jerks, hypermetric saccades)
- •Documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (e.g., history of stroke, exposure to toxins, or encephalitis; or neuroleptic use within the past 6 months)
- •*The expert evaluating physician, based on the full diagnostic assessment, believes that an alternative syndrome is more likely than PD.
- •*Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
- •*Evidence of existing dyskinesias.
- •*Diagnosis of probable behavioral variant frontotemporal dementia or primary progressive aphasia.
- •*Currently active diagnosis of a major psychiatric disorder
- •Previous brain operation or injury.
- •Active participation in another clinical trial for the treatment of PD.
- •*Any current substance use disorder.
- •Any history of recurrent or unprovoked seizures.
- •Any prior movement disorder treatments that involved intracranial surgery or device implantation.
- •Any active implanted intracranial device (e.g., cochlear implant) or implanted device to treat movement disorders (e.g., duodopa pump) whether turned on or off.
- •History of suicide attempt.
- •A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
- •Inability or unwillingness of subject to give written informed consent.
- •*Parkinsonian features restricted to the lower limbs for more than three years.
- •*Treatment with a dopamine receptor blocker or a dopamine-depleting agent in a dose and timecourse consistent with drug-induced parkinsonism.
- •Rapid progression of gait impairment requiring regular use of a wheelchair.
- •*Early bulbar dysfunction, defined as one of severe dysphonia, dysarthria (speech unintelligible most of the time), or dysphagia [requiring soft food, nasogastric (NG) tube, or gastrostomy feeding].
- •*Inspiratory respiratory dysfunction defined as either diurnal or nocturnal inspiratory stridor or frequent inspiratory sighs.
- •*Recurrent (>1/year) falls because of impaired balance within 3 years of onset.
- •*Otherwise unexplained pyramidal tract signs, defined as pyramidal weakness or clear pathologic hyperreflexia (excluding mild reflex asymmetry in the more affected limb and isolated extensor plantar response).
- •*Bilateral symmetric parkinsonism throughout the disease course. The patient or caregiver reports bilateral symptom onset with no side predominance, and no side predominance is observed on objective examination.
- •Received radiation exposure as part of other recent research studies and individuals who work around radiation will be excluded from the study
- •Subjects who do not pass the neuropsychological screening battery.
- •*Subjects who, in the opinion of the study neurologist or principal investigator, should not participate in the study
结局指标
主要结局
Daily Kinesia ONE tremor one scores over a one-week medication washout
时间窗: 1 week
Tremor score from Kinesia ONE will be reported each day of a one-week medication washout
Daily Kinesia ONE bradykinesia one scores over a one-week medication washout
时间窗: 1 week
Bradykinesia score from Kinesia ONE will be reported each day of a one-week medication washout
Changes in the Parkinson's Disease Related Pattern (PDRP) from ON medications to one-week OFF medications
时间窗: 1 week
FDG-PET scans will be used to calculate PDRP scores on day 1 (ON medications) and day 8 (off medications), and the change from ON to OFF will be reported
Changes in the Parkinson's Disease Cognitive Pattern (PDCP) from ON medications to one-week OFF medications
时间窗: 1 week
FDG-PET scans will be used to calculate PDCP scores on day 1 (ON medications) and day 8 (off medications), and the change from ON to OFF will be reported
Number of adverse events related to the medication washout
时间窗: 1 week
Any adverse event attributable to the medication washout will be reported
次要结局
未报告次要终点
研究者
Mallory Hacker
Assistant Professor of Neurology
Vanderbilt University Medical Center
研究点 (2)
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