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

June 11, 2015 updated by: Duke University

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Radiation: Group A - Early Imaging
Total of 3 scans
Other Names:
  • [123I]-FP-CIT SPECT
Active Comparator: 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.
Radiation: Group B - Delayed Imaging
Total of 2 scans
Other Names:
  • [123I]-FP-CIT SPECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson Disease Rating Scale (UPDRS)
Time Frame: 1 year
Other outcome measures will be between any group differences in UPDRS.
1 year
Life Orientation Test - Revised (LOT-R)
Time Frame: 1 year
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)
Time Frame: 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.
1 year
Obsessive - Compulsive Inventory (OCI)
Time Frame: 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.
1 year
Expectation of Global Response (EGCR)
Time Frame: 1 year
Other outcome measures will be between any group differences in EGCR.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Patrick Hickey, DO, Duke University Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00036503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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