Status:
COMPLETED
Goal Attainment Scaling (GAS) Sub-Study
Lead Sponsor:
LuMind IDSC Foundation
Collaborating Sponsors:
Ardea Outcomes Inc.
Pentara
Conditions:
Alzheimer's Disease in Down Syndrome
Eligibility:
All Genders
35+ years
Brief Summary
This is an optional sub-study that will enroll participants from LIFE-DSR parent protocol. The aim is to assess change over 16 months in individuals with Down syndrome through individualized goals set...
Detailed Description
People with Down syndrome are living longer. A longer life increases the chances of age-related risks of developing Alzheimer's disease and other forms of dementia. There is also growing evidence that...
Eligibility Criteria
Inclusion
- The participant with DS and caregiver must be currently enrolled in the LIFE-DSR parent protocol.
- The participant with DS must be age 35 years or older.
- Both the participant with DS, or LAR, and their caregiver must be able to understand and be willing to sign written informed consent.
- In the opinion of the Investigator, a participant's caregiver must have frequent interaction with the participant on a regular basis, agree to participate in clinic and remote visits, be able to provide accurate responses to questions about the participant with DS, and be capable of facilitating participation in the study visits.
- Participant with DS and caregiver must be capable of reliably completing all study assessments at each time-point.
- The caregiver must be able to converse in English.
Exclusion
- Unable to complete trial procedures or adhere to the schedule of study assessments, in the opinion of the site PI.
Key Trial Info
Start Date :
June 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06484426
Start Date
June 30 2021
End Date
February 29 2024
Last Update
July 3 2024
Active Locations (5)
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1
University of California, San Diego
San Diego, California, United States, 920347
2
Advocate Health
Park Ridge, Illinois, United States, 60068
3
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129