PD-DOC FOLLOW-UP PROTOCOL (FUP)
I. DESCRIPTION
The Parkinson’s Disease Data and Organizing Center (PD-DOC) is funded as a cooperative agreement with NINDS and serves to facilitate collaborative clinical and translational research in Parkinson’s disease (PD). A primary resource of the PD-DOC is a centralized and standardized shared database of clinical, environmental risk, neuropathological and biological data from patients with PD and controls. Subjects who complete clinical trials and other large clinical research studies in PD may be excellent sources of data for the PD-DOC Database via participation in the PD-DOC Follow-Up Protocol (FUP). Under this protocol, subjects provide informed consent to participate in standardized and systematic longitudinal, prospective follow-up after they complete the original clinical research study. The first study to enroll subjects into the FUP was the Parkinson Study Group’s PRECEPT Trial which is following participants as part of the so-called POSTCEPT Study.
II. IMPLEMENTATION
We suggest that Principal Investigators and study Steering Committees consider the PD-DOC FUP in the early stages of study planning and obtain permission for participation in the FUP as part of the original informed consent process. We also suggest that study participants be informed at the start of the research study that postmortem brain donation or at least careful brain autopsy is desired by the investigator team should any subject die during the course of the study. Site-specific information on how to make a brain donation and how to arrange brain autopsy should be provided. The ultimate inclusion of postmortem brain neuropathological information is a goal of the FUP.
Early consent for participation in the FUP is desired to minimize subjects being lost to follow-up and to avoid having a possibly biased sample of only subjects who successfully complete the research protocol. The PD-DOC has model language for the FUP that can be incorporated into study informed consent documents.
III. PROTOCOL
|
|
Estimated Time (min.) |
Baseline |
Annual |
Every 3 Years |
|
PD-DOC Core Data Set |
|
A. General Clinical |
|
Demographics
(Form 02) |
3 |
X |
|
|
|
Primary Diagnosis* (Form 04) |
1 |
X |
X |
|
|
PD Features (Form 06) |
2 |
X |
|
|
|
Diagnostic Features*
(Form 08) |
2 |
X |
|
|
|
Family History*
(Form 10) |
2 |
X |
X |
|
|
Mini-Environmental Risk Questionnaire for PD (MERQ-PD) (Form 12) |
5 |
X |
|
|
|
UPDRS (Parts I-IV)
(Forms 16,18,20,22) |
15 |
X |
X |
|
|
Modified Hoehn & Yahr Staging
(Form 24) |
1 |
X |
X |
|
|
Modified Schwab & England ADL Scale (Form 26) |
2 |
X |
X |
|
|
PD-Related Medication Log
(Form 36) |
3 |
X |
X |
|
|
B. Cognition/Behavioral |
|
Cognition/Behavior Questionnaire*
(Form 38) |
10 |
X |
|
X |
|
MMSE1 (Form 40) |
10 |
X |
|
X |
|
Hopkins Verbal Learning Test1
(Form 42) |
12 |
X |
|
|
|
Verbal Fluency – Controlled Oral Word Association Test (COWAT) (Form 44) |
5 |
X |
|
X |
|
Letter-Number Sequencing Test1
(Form 46) |
7 |
X |
|
X |
|
Geriatric Depression Scale2 (GDS-15)
(Form 48) |
5 |
X |
|
X |
|
Neuropsychiatric Inventory Questionnaire2
(NPI-Q) (Form 50)
|
10 |
X |
|
X |
|
C. Postmortem
Neuropathology
Findings
Neuropathology Form3
(PD) (Form 54) |
After Death |
|
D. Blood samples to NINDS
Genetics Repository
(Coriell) Specimen
Collection (Form 52) |
|
X |
|
|
|
E. Visit Information
Signature Form
(Form 56) |
|
X |
X |
X |
* To be completed by an expert clinician.
1 To be provided to users by the PD-DOC.
2 Self-report forms.
3 To be completed by an expert neuropathologist.
IV. SITES
The PD-DOC FUP would be conducted at the same sites that participated in the original research study, ideally the same investigators and study coordinators.
V. FINANCIAL SUPPORT
The PD-DOC will work with each study PI and Steering Committee to seek financial support for activities of site personnel as part of the FUP. Some start-up funding may be available directly from the PD-DOC.
VI. ADJUNCTIVE STUDIES
Investigators are encouraged to develop and propose adjunctive studies, such as investigation of biomarkers, involving subjects who are participating in the FUP. Additional blood and other biologic samples, for example, could be obtained for study.