Down Syndrome Clinical Trials - Study of Alzheimer's Disease in Down Syndrome

a study on Alzheimer's Disease Down Syndrome

Summary

Eligibility
for people ages 25 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study start
estimated completion
Principal Investigator
by Elizabeth Bevins-Murphy, MD

Description

Summary

The primary objective is to characterize trajectories of change on the primary outcome measures in this study population through longitudinal collection of measures of cognition, function, behavior, and health status.

Official Title

The Down Syndrome Clinical Trials Network (DS-CTN) Study of Alzheimer's Disease in Down Syndrome

Details

The DS-CTN will engage in rigorous, high quality research to better understand AD-DS and the medical needs of this population. The LIFE-DSR study will utilize the DS-CTN network to achieve these goals through evidence-based research and a combination of proven and novel methodologies. The network will initially recruit and employ experts and clinical trial sites who have access to adults with DS and whose focus is on AD-DS.

This trial also aims to develop sensitive and well-validated assessment instruments of cognition, behavior and function appropriate for future clinical trials directed at AD-DS in adults with DS ages 25 and older.

In addition, this LIFE-DSR study will serve as a parent protocol that includes one or more sub-studies, each of which has its own protocol and consent form. These sub-studies will recruit from eligible participants enrolled in this LIFE-DSR protocol.

Keywords

Alzheimer's Disease in Down Syndrome, Down Syndrome, Alzheimer's Disease, Alzheimer Disease, Syndrome

Eligibility

You can join if…

Open to people ages 25 years and up

  1. Age 25 years or older
  2. Diagnosis of DS, typically supported by karyotype analysis documenting full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21. Karyotype analysis is not required for study entry
  3. Participants, or Legal Authorized Representative, and their study partner if applicable, in the opinion of the investigator, are able to understand and willing to sign written informed consent.
  4. Participants must have a study partner who has frequent interaction with the participant on a regular basis, will agree to participate in annual clinic visits, can provide accurate responses to questions about the participant, and facilitate participation in the study visits, in the opinion of site PI or study coordinator.
  5. Participant and study partner must be capable of reliably completing study assessments.

You CAN'T join if...

Participants and study partners who, in the opinion of the site PI, are not able to complete trial procedures or adhere to the schedule of study assessments will be excluded from study participation.

Locations

  • University of California, San Diego accepting new patients
    La Jolla California 92093 United States
  • University California Irvine accepting new patients
    Irvine California 92697 United States

Lead Scientist at UCSD

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
LuMind IDSC Foundation
ID
NCT04149197
Study Type
Observational
Participants
Expecting 270 study participants
Last Updated
Contact us about this trial