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

Duke University20 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

Group A - Early ImagingRADIATION

Total of 3 scans

Group B - Delayed ImagingRADIATION

Total of 2 scans

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duke University Health Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

Unified Parkinson Disease Rating Scale (UPDRS)

Other outcome measures will be between any group differences in UPDRS.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1 year

Expectation of Global Response (EGCR)

Other outcome measures will be between any group differences in EGCR.

Time frame: 1 year

Data from ClinicalTrials.gov

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