A Study of the Brain & Body Donation Program
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Scottsdale/Phoenix, Arizona: 19-002323
Sponsor Protocol Number: 19-002323
About this study
The purpose of this study is to study the structure and biochemistry of the brain and/or bodily fluid and tissue after death. Comparison of specimens from normal and diseased individuals provide essential clues that lead to a greater understanding of the diseased state which, in turn, will lead to new ideas for therapy.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- Any subject over age 50 years old.
- Donors must reside within the greater Phoenix metropolitan area (Maricopa County), or within the greater Tucson metropolitan area (Pinal County).
- Donors must be able to come to Banner Sun Health Research Institute or affiliate institutions for annual assessments. A subset of subjects will be evaluated at collaborating institutes.
- Donors must have a friend or family member willing to serve as a study partner, someone who will be asked to provide cognitive and functional information on the donor every year.
- Included donors may be medically and functionally normal, or be diagnosed with uncured cancer, Alzheimer’s disease, Parkinson’s disease, Dementia with Lewy bodies, Multiple System Atrophy or Pure Autonomic Failure. Amongst medically and functionally normal subjects, priority will be given to those with an abnormal smell test, dream enactment behavior or repetitive head injury, after screening for these.
- Donors must not have an active infectious illness that may seriously endanger personnel exposed to bodily tissues, organs and fluids.
- Potential subjects will be asked whether they have or have ever had Hepatitis B or C, HIV/AIDS, syphilis, tuberculosis, Creutzfeldt-Jakob disease or other prion or viral encephalopathies (infectious or highly contagious brain diseases).
- Subjects with any active infectious form of these diseases will be excluded. When candidate donors are uncertain whether the potential donor has an excluded active infectious illness, they may be asked to undergo commercial laboratory blood testing for hepatitis B, C, HIV/AIDS and syphilis, and submit the results to Program enrollment staff for review. The blood draw for this may be done by the potential participant’s own private physician or by medically-qualified Program staff members. When done by Program staff, there will be no charge to the potential participant for the blood draw or blood test.
- Subjects will not be accepted into the Program until adequate medical records have been received and reviewed. The medical records of potential donors are screened for active infectious diseases as mentioned above, or other diseases that are not within the scope of our planned studies, or that would impair the usefulness of the brain for neurodegenerative brain research.
- Examples of such conditions are brain diseases other than Alzheimer’s disease, Parkinson’s disease, Multiple System Atrophy, Pure Autonomic Failure or other Lewy body disorders.
- Excluded conditions include massive stroke or intracerebral hemorrhage and/or extensive brain trauma.
- Potential donors may be excluded if the Program already has the maximum number of enrolled donors for that condition.
- The enrollment of all subjects is limited for logistical, budgetary and scientific reasons.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Publications are currently not available