Alzheimer's Disease and Related DementiasRT-D ADRDNCT06421545
Resilient Together for Dementia
A study testing Resilient Together for Dementia in people with Alzheimer's Disease and Related Dementias, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer's Disease and Related Dementias
- What is being tested?
- Resilient Together for Dementia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2024to 6 Mar 2025
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
None listed.
Who cannot join
- patient is deemed inappropriate by the neurology team,
- either partner has a co-occurring terminal illness,
- patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Injury Research Center at Mount Sinai
New York, New York, 10029
About this study
Official title: Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis
The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).
Read the detailed description
Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.
- Being tested
- Resilient Together for Dementia
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resilient Together for DementiaBehavioural
Also called RT-D
A novel live video dyadic resiliency intervention
| Study group | Role | What they receive |
|---|---|---|
| Open Pilot RT-D Dyads | Experimental | Persons living with dementia (PWDs) and their spousal care-partners Receives: Behavioral: Resilient Together for Dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of potential eligible participants
Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad.
Measured: After each dyad completion, throughout study of 1.5-2 months
Secondary outcomes (4)
Proportion of participants screened
Feasibility of screening - the portion of individuals who undergo screening that screen eligible and ineligible, and the reasons for ineligibility with detailed descriptions will be monitored and will review progress in weekly team meetings. Screening will be monitored but will not set official benchmarks and modify procedures after each dyad.
Measured: After each dyad completion, throughout study of 1.5-2 months
Proportion of participants who consent or not consent to participate
Feasibility of consent by keeping a record of all individuals who complete screening that consent, refuse to consent, and the reasons for refusal will be monitored and will review progress in weekly team meetings. Feasibility of consent will be monitored but will not set official benchmarks and modify procedures after each dyad.
Measured: After each dyad completion, throughout study of 1.5-2 months
Proportion of sessions participants attend
Feasibility of treatment -The number of sessions that enrolled dyads attend as well as missed sessions, treatment dropouts, and reasons for non attendance will be monitored and will review progress in weekly meetings. Feasibility of treatment will be monitored but will not set official benchmarks and modify procedures after each dyad.
Measured: After each dyad completion, throughout study of 1.5-2 months
Change in Hospital Anxiety and Depression Scale (HADS)
Change in emotional distress assessed with the Hospital Anxiety and Depression Anxiety Scale which is a 14-items scale with responses scored from 0-3, scores for each subscale (anxiety and depression) from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
Measured: Baseline and 6 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start19 Apr 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease and Related DementiasStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sarah Bannon, Icahn School of Medicine at Mount Sinai
- Investigators
- Sarah Bannon, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421545
- Sponsor's protocol ID
- GCO 23-0519
- Other IDs
- 1K23AG075188-01A1
- Acronym
- RT-D ADRD
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Allison GO, McCage S, Brandt S, Presciutti M, Walker K, Cornelius T, Parker RA, Dams-O'Connor K, Dickerson B, Ritchie C, Vranceanu AM, Bannon SM. "We can do this. That I learned.": A nonrandomized open pilot of Resilient Together for Dementia, a post-diagnosis dyadic intervention. BMC Geriatr. 2026 Feb 12;26(1):327. doi: 10.1186/s12877-026-07059-9.
PubMed 41652334McCage S, Walker K, Cornelius T, Parker RA, Dams-O'Connor K, Dickerson B, Ritchie C, Vranceanu AM, Bannon S. A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-Partners Early After Diagnosis: Protocol for Open Pilot of Resilient Together for Dementia. JMIR Res Protoc. 2025 Jan 15;14:e60382. doi: 10.2196/60382.
PubMed 39814366
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis
- ClinicalTrials.gov ID
- NCT06421545
- Acronym / sponsor ID
- RT-D ADRD / GCO 23-0519
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 20 May 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.
The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).
Detailed description
Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Pilot RT-D Dyads | Experimental | Behavioral: Resilient Together for DementiaPersons living with dementia (PWDs) and their spousal care-partners |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- patient is deemed inappropriate by the neurology team,
- either partner has a co-occurring terminal illness,
- patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resilient Together for DementiaAlso: RT-DA novel live video dyadic resiliency intervention | Behavioural | Open Pilot RT-D Dyads |
Primary outcome
Proportion of potential eligible participants
Time frame: After each dyad completion, throughout study of 1.5-2 months
Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad.
4 secondary outcomes
Proportion of participants screened
Time frame: After each dyad completion, throughout study of 1.5-2 months
Proportion of participants who consent or not consent to participate
Time frame: After each dyad completion, throughout study of 1.5-2 months
Proportion of sessions participants attend
Time frame: After each dyad completion, throughout study of 1.5-2 months
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline and 6 weeks (post-intervention)
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 30 Mar 2025.
- Derived from this study: PubMed 41652334Allison GO, McCage S, Brandt S, Presciutti M, Walker K, Cornelius T, Parker RA, Dams-O'Connor K, Dickerson B, Ritchie C, Vranceanu AM, Bannon SM. "We can do this. That I learned.": A nonrandomized open pilot of Resilient Together for Dementia, a post-diagnosis dyadic intervention. BMC Geriatr. 2026 Feb 12;26(1):327. doi: 10.1186/s12877-026-07059-9.
- Derived from this study: PubMed 39814366McCage S, Walker K, Cornelius T, Parker RA, Dams-O'Connor K, Dickerson B, Ritchie C, Vranceanu AM, Bannon S. A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-Partners Early After Diagnosis: Protocol for Open Pilot of Resilient Together for Dementia. JMIR Res Protoc. 2025 Jan 15;14:e60382. doi: 10.2196/60382.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Sarah Bannon principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resilient Together for Dementia in people with Alzheimer's Disease and Related Dementias, run by Icahn School of Medicine at Mount Sinai at 1 site 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 0 inclusion and 3 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Proportion of potential eligible participants (time frame: After each dyad completion, throughout study of 1.5-2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421545, which also lists 2 linked publications.
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 30 Mar 2025.