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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Group B - Delayed Imaging	Group B - Delayed Imaging	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.
Group A - Early Imaging	Group A - Early Imaging	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Recruitment & Eligibility