NCT01788696

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 parkinson-disease

Timeline
Completed

Started Jun 2012

Longer than P75 for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

2.7 years

First QC Date

February 7, 2013

Last Update Submit

June 11, 2015

Conditions

Parkinson Disease

Keywords

ParkinsonismIdiopathic Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (5)

  • Unified Parkinson Disease Rating Scale (UPDRS)

    1 year

  • Life Orientation Test - Revised (LOT-R)

    1 year

  • Marlowe - Crowne Social Desirability Scale (MCSD)

    1 year

  • Obsessive - Compulsive Inventory (OCI)

    1 year

  • Expectation of Global Response (EGCR)

    1 year

Study Arms (2)

Group A - Early Imaging

ACTIVE COMPARATOR

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

Group B - Delayed Imaging

ACTIVE COMPARATOR

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

Interventions

Group A - Early ImagingRADIATION

Total of 3 scans

Also known as: [123I]-FP-CIT SPECT
Group A - Early Imaging
Group B - Delayed ImagingRADIATION

Total of 2 scans

Also known as: [123I]-FP-CIT SPECT
Group B - Delayed Imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Patrick Hickey, DO

    Duke University Health Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2013

First Posted

February 11, 2013

Study Start

June 1, 2012

Primary Completion

March 1, 2015

Study Completion

June 1, 2015

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

US(1)