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University of Pennsylvania Alzheimers Disease Center
Our Research

June 30, 2010

Penn Memory Center
SOP for Extramural Clinical Studies

The Penn Memory Center/Alzheimer’s Disease Center (PMC/ADC) has as one of its central missions the establishment of a cohort of well-characterized healthy older individuals and patients with neurodegenerative conditions who may be recruited for studies within and beyond the University of Pennsylvania research community. Ultimately, this work should help advance our understanding and potential treatment of age-related cognitive decline and neurodegenerative diseases. The PMC/ADC clinical and research infrastructure offers a unique opportunity for recruitment of study participants with the highest level of clinical evaluation, including detailed neurological and medical assessment, a large body of annual psychometric testing, neuroimaging, and often additional biomarkers (e.g. CSF A? and tau). Much of this data is part of the National Alzheimer’s Coordinating Center’s (NACC) Uniform Dataset (UDS), which all NIA-sponsored ADC’s are required to complete. All patients are classified through consensus conference diagnosis and a rich database of clinical and research data is maintained and may be queried. Thus, there is ample opportunity to expand the scope of a particular investigation with already collected data. As part of entry into the PMC/ADC, patients sign consent to be queried about interest in other studies being performed at the Center or in the larger community.

While the PMC/ADC cohort provides significant research opportunities that are not available elsewhere in the community, resources are limited, especially related to patient burden. Participants in this cohort agree to annual testing and often are involved in a number of studies, including clinical trials and neurodiagnostic studies directed by investigators at the Center. In particular, participation in clinical trials remains a central goal. There has been tremendous growth in the number of studies being pursued and general interest in this population. Indeed, the “supply” of relevant clinical research questions is exceeding the “supply” of patient and staff resources.

Therefore, we have needed to adopt a vetting process for decisions related to our ability to collaborate on different extramural research studies. We do not have the capacity to take on all studies, although part of the mission of this SOP is to facilitate such research by increasing our efficiency and maximizing our ability to satisfy the needs of Penn’s research community. While this SOP applies to all extramural studies, our experience has been that the majority are neuroimaging, and so this will be a focus of this document. Issues with neuroimaging studies have intensified as a result of increased interest in the community related to biomarker studies, a more frequent requirement of multiple scans in clinical trials, and the fact that most of our patients generally have a limit for the number of scans they are willing to have (for our impaired patients and their caregivers, neuroimaging studies represent more than a trivial inconvenience).

1. All potential studies that plan to recruit from our cohort, must approach one of the core PMC/ADC faculty members (Steven Arnold, MD; Jason Karlawish, MD; David Wolk, MD) prior to grant submission. For all imaging-specific studies, please contact Dr. Wolk (david.wolk@uphs.upenn.edu). The earlier in the planning stage this is done, the more likely we will be able to work with you to develop your ideas in a way that will fit the constraints of the center.

2. All projects will be reviewed at a monthly meeting of the ADC/PMC Extramural Project Research Committee. This committee will review the project for feasibility, including considerations of subject burden and current study portfolio of the Center. Scientific merit and the overall goals of the ADC/PMC will also be a consideration. In order to make these decisions, the investigator must supply at least the following:

a. Specific Aims of the proposed study
b. An outline of the overall design
c. Number of patients that will need to be recruited by diagnostic category (e.g. Alzheimer’s Disease, Mild Cognitive Impairment, etc.)
d. Inclusion/Exclusion Criteria
e. Data needs (e.g. standard psychometric testing, genetic testing, clinical information, etc.)

3. All projects must utilize coordinators at the PMC/ADC for subject recruitment. One of the critical aspects of our success at maintaining a longitudinal cohort is the personal interaction/relationship that patients form with our staff. We have worked hard to create a welcoming, comfortable, “trustworthy” environment for our patients who are often vulnerable as a result of their cognitive impairment. Our coordinators are trained to recruit patients in a relatively uniform manner and record all encounters with patients in a database for each of the studies we are participating. We have a system in place for avoiding “over-calling” patients and to record their research interests. Use of our coordinators will likely increase the chances that a study will meet its recruitment goals. Thus, we will not simply provide a list of subjects to be recruited by the individual investigators. As such, studies must be budgeted to support effort of the PMC/ADC coordinators. Effort will be based on study design, the proposed population, and any additional data accrual needs pertaining to the subjects by the parent study, as determined by the Extramural Projects Research Committee.

4. Studies that involve neuroimaging (MRI, PET, etc) must provide clinical reads for scans within the constraint of the imaging modality used. Patients are much more likely to participate in studies, particularly imaging, if there is a clinical interpretation. Further, to avoid needlessly repeating MRI studies in the same patient, obtaining a clinical read from a research study may allow us to forego an additional clinical MRI. Thus, we ask that the following sequences be included in each patient.

a. T1 MPRAGE structural sequence (which can be reconstructed in a coronal plane)
b. Axial FLAIR sequence

5. Data sharing plans for imaging data will need to be established. Many of our patients have a number of different scans, both clinical and as a result of participation in different studies. To leverage this potentially valuable longitudinal data, particularly in the context of other biomarker studies, a data sharing plan must be incorporated in all studies that utilize the Center’s resources.

6. Related to the above, we may attempt to coordinate scanning sequences between different studies being performed at the Center, as another attempt to avoid over-burdening patients with repeat MRI studies. Investigators should focus on key sequences for their study, but allow at least 20 minutes of time for additional sequences (most patients can tolerate 40 to 50 minutes of scanning).

Please feel free to contact us with any questions related to the above. We look forward to working with you.

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