Skip to main content
OpenTrials
Completed

NCT Number: NCT01788696

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Duke University Health Center

Durham, North Carolina, 27705, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group A - Early Imaging

Radiation

Total of 3 scans

Other names: [123I]-FP-CIT SPECT

Group B - Delayed Imaging

Radiation

Total of 2 scans

Other names: [123I]-FP-CIT SPECT

Primary outcomes

  1. 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

  1. Unified Parkinson Disease Rating Scale (UPDRS)

    Time frame: 1 year

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

  2. 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.

  3. 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.

  4. 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.

  5. Expectation of Global Response (EGCR)

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

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)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 11, 2013
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.