Down Syndrome Biomarker Initiative (DSBI)
Launched by MICHAEL RAFII · May 19, 2014
Trial Information
Current as of July 21, 2025
Completed
Keywords
ClinConnect Summary
The overall goal of this project is to determine the relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as the pathology evolves from normal aging through very mild symptoms, to mild cognitive impairment (MCI), to dementia in adults with Down syndrome. This is a pilot study modeled after the Alzheimer's Disease Neuroimaging Initiative (ADNI) to inform the neuroscience community of AD in DS, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male and female subjects 30 to 60 years of age inclusive with chromosome karyotype of Down Syndrome due to Trisomy 21.
- • Subjects must have a study partner (parent or other reliable caregiver) who has at least 10 hours of contact and who agrees to accompany the subject to all clinic visits and provide information about the subject's behavior and symptoms.
- • Participant is able to speak/communicate.
- • Subject is willing and has no contraindications to MRI scanning.
- • Participant or parent/legal guardian provides consent.
- • Participant must agree to allow for indefinite storage of his/her data and samples.
- Exclusion Criteria:
- • Patients who are anarthric or mute.
- • Patients who do not meet the criteria for the diagnosis of DS.
- • Patients unwilling or unable to participate in all tests and procedures.
- • Unstable medical or behavioral issues.
- • Unable or unwilling to perform MRI and/or PET imaging.
About Michael Rafii
Dr. Michael Rafii is a distinguished clinical trial sponsor known for his extensive contributions to neurological research and the advancement of innovative therapeutic strategies for neurodegenerative diseases. With a robust academic background and a commitment to improving patient outcomes, Dr. Rafii leads and oversees clinical trials aimed at evaluating novel treatments, fostering collaboration among multidisciplinary teams, and ensuring adherence to regulatory standards. His expertise in trial design and execution, coupled with a patient-centered approach, positions him at the forefront of clinical research, driving impactful discoveries that enhance the understanding and management of complex neurological conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
La Jolla, California, United States
Patients applied
Trial Officials
Michael S. Rafii, MD, PhD
Principal Investigator
University of California, San Diego
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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