Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00857532
Eligibility Criteria:
Inclusion Criteria:
* Subjects may be enrolled if they (inclusion criteria):
* Are males or females ≥60 years of age
* Meet research diagnostic criteria for Parkinson's disease:
* Diagnosis of a parkinsonian syndrome
* Bradykinesia (slowness of initiation of voluntary movement with progressive reduction in speed and amplitude of repetitive actions)
* At least one of the following: muscle rigidity, rest tremor, postural instability not due to visual, vestibular, cerebellar or proprioceptive causes
* Supportive criteria for diagnosis of PD (two or more required)
* Unilateral onset of symptoms and persistent asymmetry
* Rest tremor present
* Progressive illness
* Excellent response to levodopa with dyskinesias
* Levodopa response for 5 years or more
* Clinical course of 10 years or more
* Have the ability to lie flat and tolerate a 10 minute PET scan.
Exclusion Criteria:
* Subjects may not be enrolled if any of the following are present (exclusion criteria):
* History of repeated strokes, repeated head injury, definite encephalitis
* Use of neuroleptics at onset of symptoms
* Sustained remission
* Strictly unilateral feature persisting \> three years after onset
* Significant supranuclear gaze palsy
* Cerebellar, pyramidal and early severe autonomic findings
* Early severe dementia suggesting a diagnosis of dementia with Lewy bodies (DLB)
* Imaging study showing structural abnormality that could explain parkinsonism
* Negative response to an adequate levodopa trial
* Current clinically significant psychiatric disease that prohibits providing informed consent or participation in the study
* Current clinically significant endocrine or metabolic disease, pulmonary,
* Women of childbearing potential who are not two or more years post menopausal or surgically sterilized
* Have received any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00857532
Study Brief:
Protocol Section:
NCT00857532