ClinConnect ClinConnect Logo
Search / Trial NCT02141971

Down Syndrome Biomarker Initiative (DSBI)

Launched by MICHAEL RAFII · May 19, 2014

Trial Information

Current as of July 21, 2025

Completed

Keywords

Down Syndrome Alzheimer's Disease Biomarkers Amyloid Tau

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.

Locations

La Jolla, California, United States

Patients applied

0 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

Similar Trials