An interventional study of SIRENS application and SIRENS screening in Dementia, Elder Abuse and Elder Mistreatment, sponsored by Weill Medical College of Cornell University. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Supportive care
Among 1,049 studies in Dementia with a site in United States — 211 open to participants now, 277 under way, 15 of them phase 3. Dementia · United States.
Among the 1,049 studies in Dementia with a site in United States, this one is the 81st largest by planned enrollment of the 845 interventional ones that give a count, is one of 7 that started in 2027, is one of 561 with no phase, reaches primary completion later than 156 of the 276 other live ones, and was the 1,030th registered.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
Browse Dementia studies →211 of the 1,049 studies in Dementia with a site in United States are open now. Recruiting first, the newest first:
University of Nebraska · Sites in United States
Ages 50+ · Women only · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 65+
The University of Texas Medical Branch, Galveston · Sites in United States
Ages 50–100 · Healthy volunteers
Weill Medical College of Cornell University · Sites in United States
Ages 21+ · Healthy volunteers
The Cleveland Clinic · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 381 Dementia studies recruiting now, 242 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 163 take healthy volunteers.
This study: 21 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,049 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 73 · Phase 2 146 · Phase 3 79 · Phase 4 33
First in 1981; this study’s year is marked. 7 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 774 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Median enrollment 92 across the 845 interventional studies, 200 across the 199 observational. Of the 713 that completed or were terminated, 308 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
191 of 1,049 have an industry lead sponsor. The 10 most frequent:
Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
Weill Medical College of Cornell University has 9 studies filed under Dementia — fewer than ten, so there is no comparison to draw.
108 of the studies in Dementia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05543681IGC Pharma, LLCClinical Trial on Agitation in Alzheimer's Dementia | 2026-11 |
| NCT07430371Rendever, Inc.Virtual Reality for Caregiver Assembly, Relief, Empowerment, and Support (VR-CARES) | 2026-11 |
| NCT06095284Virginia Commonwealth UniversityPrescribing Trends and Associated Outcomes of Antiepileptic Drugs in US Nursing Homes Surrounding the COVID-19 Pandemic | 2026-11-30 |
| NCT06298474Hopeful AgingThe BRAIN App (Phase 2 SBIR) | 2026-11-30 |
| NCT07859865Drexel UniversityMindfulness-based Movement Therapy for Persons With Dementia and Family Caregivers | 2026-11-30 |
Add all 108 to your calendar (.ics) → With an account.
Among the 1,049 studies in Dementia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate the impact of screening for elder neglect in older adults with dementia in primary care settings and the impact of an intervention for caregivers of older adults with dementia.
The hypothesis of the study are:
Researchers will compare three groups of participants to find out how effective the screening tool is on its own, and how effective it is when combined with the support program, compared to standard care.
Participants will be asked to:
Primary care provider Inclusion Criteria • Active PCP who may be a physician or nurse practitioner seeing adult primary care patients with dementia at: Weill Cornell Medicine
Primary care provider Exclusion Criteria
Older Adult Inclusion Criteria:
Older Adult Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
Behavioral: SIRENS application · Other: SIRENS screening
Other: SIRENS screening
The SIRENS intervention is a technology intervention designed specifically for caregivers of those with dementia, providing them with easy access to expert-reviewed information and helpful resources. The content includes take-home messages summarizing the main points discussed and a goal-setting feature that encourages the care givers to establish small, actionable goals.
The SIRENS screening tool is a novel, easy-to-use, brief screening tool to identify elder neglect in primary care settings.
Percent change in number of participants with the presence of neglect determined by the Vulnerable Elder Protection Team (VEPT) from baseline at 6 months
Caregiver abuse screen is a yes/no 8-question survey that asks about high stress and tendencies that could lead to future abuse. More "yes" answers indicate higher likelihood of current abuse and neglect, and future risk. The PCP Neglect Screening Questionnaire asks primary care providers for concern for caregiver neglect and level of concern using a 5-point scale. Higher scores indicate increased concern. Provider Observations survey asks for the primary care provider's subjective observations on the older adult's physical health. Electronic Health Record Data Elements survey extracts information from medical charts for hemoglobin, creatinine, and blood urea nitrogen lab results. Information from these surveys are used by the VEPT Expert Panel to determine presence of neglect.
Time frame: Baseline; 6 months
Change in severity of neglect determined by the Vulnerable Elder Protection Team (VEPT) using the Health-Related Severity in Elder Neglect Scale from baseline at 6 months
The VEPT Expert Panel's impression of the change in severity of neglect will be measured by the Health-Related Severity in Elder Neglect Scale. This scale asks providers two yes/no questions whether there is concern for caregiver neglect based on the screening tools and clinical assessment. If yes, their level of concern is asked based on the scale: Not Present; Not Present, Potential Risk; Present, Mild; Present, Moderate; and Present, Severe. There is no numerical or total score.
Time frame: Baseline; 6 months
Mean change in score for caregiver burden from baseline at 6 months.
Caregiver burden will be assessed in care partner participants using the reliable and valid Caregiver Burden Scale. Response options range from 0= Never to 4= Nearly always. Questions include those asking about relationship with the care recipient and stress. Overall scores range from 0 to 48, with higher scores indicating more caregiver burden.
Time frame: Baseline; 6 month
Mean change in score of caregiver quality of life from baseline at 6 months
Caregiver quality of life will be assessed in care partner participants using the reliable and valid Quality of Life Inventory survey. Questions include those asking about importance (on a 3-point rating scale, higher value indicating more importance) and satisfaction (on a 6-point rating scale, higher value indicating more satisfaction) of life domains. Importance scores are multiplied by satisfaction scores for each domain, and then these scores are summed to determine the overall score. Overall scores range from -96 to 96, with higher scores indicating higher quality of life.
Time frame: Baseline; 6 month
Mean change in score of older adult quality of life from baseline at 6 months
Older adult quality of life will be assessed in patients using the reliable and valid Quality of Life Dementia survey. Questions include those asking about subjective wellbeing using a 5-point rating scale across five domains: self-esteem, positive affect, negative affect, feelings of belonging, sense of aesthetics. Mean scores are computed for each domain, with high scores indicating more satisfaction (negative affect is reverse scored). Domain scores range from 1 to 5, with higher scores indicating higher quality of life. There is no total overall score.
Time frame: Baseline; 6 month
Mean change in score of caregiver preparedness from baseline at 6 months
Caregiver preparedness will be assessed in care partner participants using the Caregiver Preparedness Scale. Response options range from 0= Not at all prepared to 4= Very well prepared. Overall scores range from 0 to 24 with higher scores indicating more feelings of preparedness.
Time frame: Baseline; 6 month
Mean change in score of caregiving self-efficacy from baseline at 6 months
Caregiving self-efficacy will be measured in care partner participants by a modified Caregiving Self-Efficacy Scale. Response options range from 0= Can not do at all to 100= Certainly can do. Overall scores range from 0 to 900 with higher scores indicating more confidence.
Time frame: Baseline; 6 month
Mean change in score of caregiver depression from baseline at 6 months
Caregiver depression will be assessed in care partner participants using the reliable and valid Center for Epidemiologic Studies Depression Scale. Response options range from 0= Rarely or none of the time to 3= Most or almost none of the time. Overall scores range from 0 to 60 with higher scores indicating greater depressive symptoms.
Time frame: Baseline; 6 month
Number of heath outcomes determined by medical chart review
Number of each health outcome such as deaths, hospitalizations and use of medical services. Additional health-related outcomes will be included as identified.
Time frame: 6 month
Count of the primary care provider's impression of the presence of neglect and severity of neglect measured by the Health-Related Severity in Elder Neglect Scale
The primary care provider's impression of the presence of neglect and severity of neglect will be measured by the Health-Related Severity in Elder Neglect Scale. This scale asks providers two yes/no questions whether there is concern for caregiver neglect based on the screening tools and clinical assessment. If yes, their level of concern is asked based on the scale: Not Present; Not Present, Potential Risk; Present, Mild; Present, Moderate; and Present, Severe. There is no numerical or total score.
Time frame: Baseline; 6 month
Number of individual actions taken after positive neglect screen determined by medical chart review
Number of each individual action taken after positive neglect screen. Actions will be included as identified.
Time frame: Baseline; 6 month
Change in technology acceptance score from post-intervention at 6 months
Use of the intervention will be determined by the Technology Acceptance Scale which assesses system acceptance in two dimensions: a Usefulness scale and an affective Satisfying scale. Response options range from -2 to 2. Items 3, 6, and 8 are mirrored and should be scored -2..+2. The Usefulness scale is the sum of item 1 + 3 + 5 + 7 + 9 divided by 5, the Satisfying scale is the sum of items 2, 4, 6, and 8, divided by 4. Each scale has a total score that ranges from -2 to +2, with higher scores indicating more usefulness or satisfaction. The scales are not combined for a total score.
Time frame: Post-intervention (5 week); 6 month
Plan to share: Yes — The investigators plan for resource sharing is based on the National Institutes of Health/National Institute on Aging (NIH/NIA) Data Sharing Policy. The investigators plan, consistent with the NIH goals of data sharing, is to promote use of the rich SIRENS database by the larger research community as this will further the impact of SIRENS and expand possibilities for collaboration. It will also allow other researchers to expedite the translation of the research findings into knowledge, products, and procedures. Further, the plan is devised to make the data as widely and freely available as possible while at the same time safeguarding the privacy of participants and protecting confidential and proprietary data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data from research projects will be made available no later than acceptance of publication of the main findings from the final data set. There is no end date to access the data from the research projects.
Access criteria: The investigators agree to share the data with researchers working under an institution with Federal Wide Assurance who agree to a data sharing agreement that stipulates protection of participant privacy and data confidentiality, acknowledgement of SIRENS, that the data will be used for research purposes only, and that the data will not be transferred to other users. The computerized data will include raw data, derived variables, all necessary documentation as described in the National Archive of Computerized Data on Aging depositor agreement. All data will be de-identified. The investigators will follow the guides published by the US Department of Health and Human Services in this respect. Each data set will include data documentation to ensure that others can use the data set and to minimize confusion. Information about where and how to locate and access the data will be available in any publications and presentations authored by SIRENS investigators.
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Jul 2027, 4 months later.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 4 months is below that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Mar 2027, on Nov 12, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Weill Medical College of Cornell University →