Status:
COMPLETED
Feasibility Of Objective Measures and Outpatient Washout in Disease Modifying Trials for Parkinson's Disease
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Parkinson Disease
Eligibility:
All Genders
50-75 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- \*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.
Exclusion
- \*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
Key Trial Info
Start Date :
March 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 18 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06192823
Start Date
March 22 2022
End Date
February 18 2025
Last Update
April 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232