Alzheimer's Disease in Down SyndromeNCT06484426
Goal Attainment Scaling (GAS) Sub-Study
An observational study of Alzheimer's Disease in Down Syndrome, run by LuMind IDSC Foundation at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Alzheimer's Disease in Down Syndrome
- How many people
- 46 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jun 2021to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- Unable to complete trial procedures or adhere to the schedule of study assessments, in the opinion of the site PI.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02129
Case Western Reserve University School of Medicine
Cleveland, Ohio, 44106-6090
Advocate Health
Park Ridge, Illinois, 60068
University of California, San Diego
San Diego, California, 920347
About this study
Official title: The Goal Attainment Scaling in Down Syndrome-associated Alzheimer's Disease (DS-AD) Sub-study
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.
Read the 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.
- Conditions
- Alzheimer's Disease in Down Syndrome
- Keywords
- Down Syndrome, Alzheimer's Disease
- Medical subject headings
- Down Syndrome, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scaling (GAS)
Patient centered outcome measure aiming to assess change 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.
GoalNav® DS-AD Instrument
This is a web-based platform developed by Ardea Outcomes with a DS-AD menu of 58 symptoms/challenges developed in collaboration with LuMind IDSC Foundation. This instrument is intended to track pre-dementia and dementia symptoms over time, including behaviors and other challenges common in adults with DS-AD.
The goal scale is a 5-point scale. Minimum value is 1 maximum value is 5
No indicators of what higher or lower scores mean.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start30 Jun 2021
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease in Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- LuMind IDSC Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ardea Outcomes Inc., Pentara
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484426
- Sponsor's protocol ID
- LIFE-DSR-GAS DS-AD
- Status last verified
- Jun 2024
- First submitted
- 20 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Goal Attainment Scaling in Down Syndrome-associated Alzheimer's Disease (DS-AD) Sub-study
- ClinicalTrials.gov ID
- NCT06484426
- Acronym / sponsor ID
- LIFE-DSR-GAS DS-AD
- Conditions
- Alzheimer's Disease in Down Syndrome
- Keywords
- Down Syndrome, Alzheimer's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- LuMind IDSC FoundationUniversity, hospital or other
- Collaborators
- Ardea Outcomes Inc., Pentara
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Unable to complete trial procedures or adhere to the schedule of study assessments, in the opinion of the site PI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Goal Attainment Scaling (GAS)
Time frame: 16 months
Patient centered outcome measure aiming to assess change 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. GoalNav® DS-AD Instrument This is a web-based platform developed by Ardea Outcomes with a DS-AD menu of 58 symptoms/challenges developed in collaboration with LuMind IDSC Foundation. This instrument is intended to track pre-dementia and dementia symptoms over time, including behaviors and other challenges common in adults with DS-AD. The goal scale is a 5-point scale. Minimum value is 1 maximum value is 5 No indicators of what higher or lower scores mean.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease in Down Syndrome, run by LuMind IDSC Foundation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scaling (GAS) (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.