- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00585572
Wisconsin Brain Donor Program (WBDP)
University of Wisconsin-Madison: Wisconsin Brain Donor Program (WBDP)
Study Overview
Status
Conditions
Detailed Description
The Wisconsin Brain Donor Program (WBDP) of the University of Wisconsin-Madison School of Medicine and Public Health is considered an investigator-initiated project. It was first established in 1995 to promote teaching and research in neurodegenerative diseases. In 2009 the WBDP aligned itself with the research goals of the Wisconsin Alzheimer's Disease Research Center (Wisconsin ADRC) in order to more effectively serve the research community. As a result, the WBDP is part of a nationwide network of ADC/ADRC's (Alzheimer's Disease Centers/Alzheimer's Disease Research Centers), funded by the National Institute on Aging that exists to promote research on neurodegenerative diseases. However, the WBDP operates as an independent research program under the direction of the WBDP and Wisconsin ADRC Principal Investigators.
The WBDP provides approved researchers access to indefinitely-stored postmortem brain tissues and post-mortem biospecimens (subject to the availability of remaining stock). Postmortem biospecimens also include CSF and whole blood.
The WBDP staff promotes and educates the lay community on the importance of brain donation.
Goal/Objectives The overall goal of the WBDP is to function as a useful brain tissue and biospecimen repository by distributing these materials to approved researchers studying neurodegenerative diseases, particularly Alzheimer's disease (AD).
To achieve this goal, the WBDP has adopted the following overall objectives:
- To serve as the tissue and biospecimen repository for the Wisconsin ADRC and Wisconsin ADRC-affiliated studies. In this role, the WBDP will support collaborative research by providing postmortem tissues, biospecimens, and genetic/genomic data for AD and other neurodegenerative illnesses to approved researchers, whether at the University of Wisconsin-Madison or other approved institutions. The investigators will also promote data and sample sharing with ADRC Clinical Core, WRAP, and ADRC-affiliated studies such as ADNI, DOD-ADNI, and ADNI Brain Bank.
- To establish a registered group of individuals who intend to donate their brain tissue and biospecimens after death for neurodegenerative-disease related research (the WBDP Registry).
- To oversee all aspects of brain tissue and biospecimen collection and management (their procurement, indefinite storage, and distribution to approved researchers).
- To collaborate with the National Alzheimer's Coordinating Center (NACC), the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD) and similar organizations, by providing coded biologic samples and data, inclusive of genetic data, in order to further AD research.
Due to the nature of this study, no specific number of subjects is being proposed. This will be an ongoing brain donation registry until funding is not renewed.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Madison
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Is aged 18 years or older
Falls into one of the following categories:
- Current or previous study participants involved in the ADRC Clinical Core, WRAP study, or other select ADRC-affiliated studies, or donors of special circumstance, including healthy controls, if approved on a case-by-case basis by the WBDP PI. Please note, ADRC-affiliated studies are not inclusive of ADRC-affiliated industry-sponsored studies.
- Is a parent of either an ADRC Clinical Core or WRAP study participant, or is a spouse of a WRAP study participant.
Exclusion Criteria:
- VA research subjects
Subjects with a medical condition/disease that would exclude them from the spectrum of utility/interest to researchers as determined by a WBDP Neuropathologist:
- Persons with Hepatitis B or C
- Severe Traumatic Brain Injury
- Positive CJD diagnosis
- Persons with HIV/AIDS
- Persons with brain tumors or blood clots that affect neurologic status, therefore creating a problem between diagnosing AD status and healthy status
- Cancer that has metastasized to the brain
- Radiation treatment to the head
- Other infectious diseases that would be hazardous to staff handling the tissue
- Prolonged ventilator dependency prior to death as determined by the Neuropathologist
- Subjects who lack capacity to provide informed consent with no activated Power of Attorney (POA) for Healthcare, activated POA for Research, or legal guardianship (if not near death), or (if at or near death) have no spouse, parent, relative or friend willing/able to complete consent and other donation paperwork.
- Subjects who otherwise have incomplete history or incomplete donation paperwork before a recovery can begin.
- Subjects younger than 18 years of age.
- An expected post-mortem interval (PMI) of greater than 16 hours for non-ADRC or non-WRAP participants. PMI is the time between death and the anticipated time of brain removal at autopsy. Families and recovery agencies are made aware of this time constraint when consenting for the recovery process. If a patient becomes ineligible due to PMI, the family and funeral home will be notified immediately. Diversions from this exclusion can be made by a WBDP PI or Co-PI.
- Medical conditions that would put researchers at risk.
- Other contingencies, as determined by the PI, that make enrollment impractical or unsafe.
Note: It is anticipated, based upon the younger age of our study cohorts, that significant time may pass between WBDP registration and actual donation. The inclusion/exclusion criteria will be reviewed and applied at time of donation. As a result, donated tissue found to be unsuitable may be removed from the post-mortem tissue and biosamples collection.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shahriar Salamat, MD PHD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2010-0037 (Other Identifier: Minimal Risk Research IRB)
- A534255 (Other Identifier: UW Madison)
- 2014-1484 (Other Identifier: Minimal Risk Research IRB)
- GERIATRICS AND ADULT (Other Identifier: UW Madison)
- 2RF1AG027161-11A1 (U.S. NIH Grant/Contract)
- 1P30AG062715-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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