Parkinson Disease
Conditions
Keywords
Parkinsonism, Idiopathic Parkinson Disease
Brief summary
The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).
Detailed description
The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.
Interventions
RADIATIONGroup A - Early Imaging
Total of 3 scans
RADIATIONGroup B - Delayed Imaging
Total of 2 scans
Sponsors
GE Healthcare
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 18-80; * diagnosis of idiopathic PD exhibiting at least 2 of 3 cardinal signs (bradykinesia, rigidity and resting tremor); * maximum duration of previous exposure to anti-parkinsonian therapy being \< 8 weeks; * ability to signed informed consent; * willingness and ability to complete medication diary and questionnaires; * if a female subject of child-bearing potential, the use of an effective method of contraception.
Exclusion criteria
* current treatment with anti-parkinsonian medication; * previous treatment with anti-parkinsonian medication for greater than 8 weeks; * inability to complete questionnaires; * unwillingness to complete all questionnaires and medication diary; * subjects with secondary causes of parkinsonism; * participant has evidence of clinical significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder; * positive serum/urine pregnancy test at any time during the study period; * the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the DSM-IV within the past 2 years; * participation in a concurrent PD trial within 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient adherence to treatment plan | 1 year | Patient and treating physician agree on a treatment plan at visit 3. Patient adherence to medications will be evaluated based on pill count at each follow-up study visit. Additionally, each patient will record their adherence to therapy on the Patient Expectations and Disease-related Questionnaire (PEDQ) at each follow-up study visit, allowing the study team to track compliance with pharmacologic therapy as well as treatments including therapy exercise plans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson Disease Rating Scale (UPDRS) | 1 year | Other outcome measures will be between any group differences in UPDRS. |
| Life Orientation Test - Revised (LOT-R) | 1 year | Other outcome measures will be between any group differences in LOT-R. This test assesses individual differences in generalized optimism versus pessimism. |
| Marlowe - Crowne Social Desirability Scale (MCSD) | 1 year | Other outcome measures will be between any group differences in MCSD. This test assesses the extent to which individuals attempt to depict themselves as similar to the norms and standards of their society and community. |
| Obsessive - Compulsive Inventory (OCI) | 1 year | Other outcome measures will be between any group differences in OCI. This self-report scale assesses distress from symptoms commonly experienced in obsessive-compulsive disorder. |
| Expectation of Global Response (EGCR) | 1 year | Other outcome measures will be between any group differences in EGCR. |
Countries
United States
Outcome results
None listed