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

Duke University

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Radiation: Group B - Delayed Imaging; Radiation: Group A - Early Imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01788696

Pro00036503

Details and patient eligibility

About

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).

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A - Early Imaging

Active Comparator group

Description:

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.

Treatment:

Radiation: Group A - Early Imaging

Group B - Delayed Imaging

Active Comparator group

Description:

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.

Treatment:

Radiation: Group B - Delayed Imaging