Clinical trial NCT06484426: Goal Attainment Scaling (GAS) Sub-Study
Official title: The Goal Attainment Scaling in Down Syndrome-associated Alzheimer's Disease (DS-AD) Sub-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease in Down Syndrome
Keywords: Down Syndrome
Alzheimer's Disease
Lead sponsor: LuMind IDSC Foundation
Sponsor class: OTHER
Collaborators: name: Ardea Outcomes Inc.
name: Pentara
First posted: 2024-07-03
Enrollment: 46
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females, aged 35 and older, with a diagnosis of DS. Must be enrolled in the LIFE-DSR (the parent study to the GAS sub-study)

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 Alzheimer's 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 participant's 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 Alzheimer's 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 participant's feedback about the participant's 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.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

Unable to complete trial procedures or adhere to the schedule of study assessments, in the opinion of the site PI.

Primary outcomes:
measure: Goal Attainment Scaling (GAS)
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Park Ridge
country: United States
facility: Advocate Health
state: Illinois
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Case Western Reserve University School of Medicine
state: Ohio
Study officials:
References: