Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484426
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-03-20
Brief Title:
Goal Attainment Scaling GAS Sub-Study
Sponsor:
LuMind IDSC Foundation
Organization:
LuMind IDSC Foundation
Study Overview
Official Title:
The Goal Attainment Scaling in Down Syndrome-associated Alzheimers Disease DS-AD Sub-study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 by their caregivers This sub-study also aims to assess the feasibility of Goal Attainment Scaling in the DS-AD population
Detailed Description:
People with Down syndrome are living longer A longer life increases the chances of age-related risks of developing Alzheimers disease and other forms of dementia There is also growing evidence that people with Down syndrome respond differently to treatment than people without Down syndrome This creates an important need to create a way to identify and follow changes in thinking and behavior as people with Down syndrome age and start to experience symptoms of dementia Here the investigators are testing a new method to monitor changes in thinking and behavior called goal attainment scaling
During this study the participant will be asked to take part in a goal attainment scaling interview which means working with a clinical rater the participants health care provider or other study team to identify personally meaningful goals to follow for the study Goals are based on symptoms or challenges experienced by the person for whom cares for the participant with Down Syndrome The identified goals may be related to potential early signs and symptoms of Alzheimers disease These goals will then be reviewed at 2 time-points over the next 16 months The investigators want to learn whether this type of interview can help the investigators understand what symptoms or challenges are important to the participant and whether this type of interview can help the investigators understand how these might change over time The investigators also want to hear the participants feedback about the participants experience with goal attainment scaling at the end of the sub-study
The investigators will be asking about 45 participants to take part in this study
This study is observational and does not test a study drug
During this study the participant will be asked to take part in a goal attainment scaling interview which means working with a clinical rater the participants health care provider or other study team to identify personally meaningful goals to follow for the study Goals are based on symptoms or challenges experienced by the person for whom cares for the participant with Down Syndrome The identified goals may be related to potential early signs and symptoms of Alzheimers disease These goals will then be reviewed at 2 time-points over the next 16 months The investigators want to learn whether this type of interview can help the investigators understand what symptoms or challenges are important to the participant and whether this type of interview can help the investigators understand how these might change over time The investigators also want to hear the participants feedback about the participants experience with goal attainment scaling at the end of the sub-study
The investigators will be asking about 45 participants to take part in this study
This study is observational and does not test a study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None