Objective: To compare the clinical and imaging characteristics of those PRECEPT (Parkinson Research Examination of CEP-1347 Trial) subjects with a scan without evidence of dopaminergic deficit (SWEDD) to those with dopamine transporter (DAT) deficit scans at study baseline and during a 22-month follow-up.Methods: Baseline (n 5 799) and 22-month follow-up (n 5 701) [123 I] b-CIT SPECT scans were acquired. The percent change in [123 I] b-CIT striatal binding ratio, the percentage of subjects requiring dopaminergic therapy, the change in Unified Parkinson's Disease Rating Scale (UPDRS) score, and the PRECEPT Study investigators' diagnosis at study termination were compared between SWEDD and DAT deficit subjects.Results: SWEDD subjects (n 5 91) compared with DAT deficit subjects (n 5 708) showed reduced .9], p , 0.0001) at follow-up assessments. At PRECEPT termination, the diagnosis by study investigators was changed from Parkinson disease (PD) to other disorders not associated with DAT deficit in 44% (95% confidence interval 34.2, 54.7) of SWEDD subjects compared with 3.6% (95% confidence interval 2.3, 5.1) of DAT deficit subjects.
Conclusion:These results indicate that subjects identified as having a SWEDD, with DAT imaging within the normal range, have minimal evidence of clinical or imaging PD progression. These data strongly suggest that SWEDD subjects are unlikely to have idiopathic PD. In several recent Parkinson disease (PD) clinical trials, dopaminergic imaging has been used as a tool to assess PD progression. Both dopamine transporter (DAT) SPECT and [ 18 F] fluoro-Ldopa PET imaging identified research subjects having a scan without evidence of dopaminergic deficit (SWEDD) enrolled in PD clinical trials of newly diagnosed untreated patients. [1][2][3][4] In PD studies enrolling participants within 9 months of PD diagnosis, approximately 10% to 15% of the research subjects have a SWEDD. Longitudinal assessment has demonstrated that those subjects with a SWEDD at baseline continue to have a SWEDD in follow-up scans for at least a 4-year period.
5The Parkinson Research Examination of CEP-1347 Trial (PRECEPT) was a multicenter, randomized, double-masked, placebo-controlled study to examine the efficacy and long-term safety of CEP-1347 as a potential disease-modifying treatment in patients with early PD.