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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Patient adherence to treatment plan
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Patient adherence to treatment plan
Time Frame: 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 Outcomes
- Obsessive - Compulsive Inventory (OCI)(1 year)
- Expectation of Global Response (EGCR)(1 year)
- Unified Parkinson Disease Rating Scale (UPDRS)(1 year)
- Life Orientation Test - Revised (LOT-R)(1 year)
- Marlowe - Crowne Social Desirability Scale (MCSD)(1 year)