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)

Duke University1 site in 1 country20 target enrollmentJune 2012

ConditionsParkinson Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Duke University
Enrollment: 20
Locations: 1
Primary Endpoint: Patient adherence to treatment plan
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

Eligibility Criteria

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.