Pilot Study To Assess Effect of Treatment and Adherence in PD Subjects

Study Overview
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Brief Summary
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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
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The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.

Official Title
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Assessment of the Effect of Treatment Pathways, Adherence, and Treatment Efficacy in Parkinson's Disease Subjects Randomized to SPECT Imaging of the Dopamine Transporter (Ioflupane I123 Injection)

Conditions
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Parkinson Disease

Intervention / Treatment
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* Radiation: Group A - Early Imaging
* Radiation: Group B - Delayed Imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A - Early Imaging<br>Group A will receive SPECT imaging 3 times during the study. The first scan will take place prior to the initiation of any treatment, followed by scans at week 26 and week 52. | Radiation: Group A - Early Imaging<br>* Total of 3 scans<br>* Other names: [123I]-FP-CIT SPECT;|
| Active Comparator: Group B - Delayed Imaging<br>Group B will receive SPECT imaging 2 times during the study. Group B will not have the first scan (prior to the initiation of any treatment). Scan will take place at week 26 and week 52. | Radiation: Group B - Delayed Imaging<br>* Total of 2 scans<br>* Other names: [123I]-FP-CIT SPECT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient adherence to treatment plan | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson Disease Rating Scale (UPDRS) | Other outcome measures will be between any group differences in UPDRS. | 1 year | 
| Life Orientation Test - Revised (LOT-R) | Other outcome measures will be between any group differences in LOT-R. This test assesses individual differences in generalized optimism versus pessimism. | 1 year | 
| Marlowe - Crowne Social Desirability Scale (MCSD) | 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. | 1 year | 
| Obsessive - Compulsive Inventory (OCI) | 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. | 1 year | 
| Expectation of Global Response (EGCR) | Other outcome measures will be between any group differences in EGCR. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinsonism, Idiopathic Parkinson Disease