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

NCT ID: NCT01788696

Last Updated: 2015-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-06-30

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).

Detailed Description

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Group A - Early Imaging

Intervention Type: RADIATION

Total of 3 scans

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 Type: ACTIVE_COMPARATOR

Group B - Delayed Imaging

Intervention Type: RADIATION

Total of 2 scans

Interventions

Group A - Early Imaging

Total of 3 scans

Intervention Type: RADIATION

Group B - Delayed Imaging

Total of 2 scans

Intervention Type: RADIATION

Other Intervention Names

[123I]-FP-CIT SPECT; [123I]-FP-CIT SPECT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Hickey, DO

Role: PRINCIPAL_INVESTIGATOR

Duke University Health Center

Locations

Duke University Health Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00036503

Identifier Type: -

Identifier Source: org_study_id