An interventional study of Experimental arm in Dementia, Nurse Care Coordination and Informal Caregiver, sponsored by German Center for Neurodegenerative Diseases (DZNE). Recruiting at 12 sites in Germany. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by German Center for Neurodegenerative Diseases (DZNE) · Not applicable, Interventional, and Supportive care
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Among 96 studies in Dementia with a site in Germany — 13 open to participants now, 18 under way, 8 of them phase 3. Dementia · Germany.
Among the 96 studies in Dementia with a site in Germany, this one is the 25th largest by planned enrollment of the 77 interventional ones that give a count, is one of 2 that started in 2026, is one of 28 with no phase, reaches primary completion later than 6 of the 17 other live ones, and was the 91st registered.
2,373 studies on the registry are indexed under Dementia; 574 are open to participants now.
Browse Dementia studies →13 of the 96 studies in Dementia with a site in Germany are open now. Recruiting first, the newest first:
Exciva GmbH · Sites in Germany, United States, Canada and 6 more countries
Ages 55–90
University Hospital, Bonn · Sites in Germany
Ages 50–80 · Healthy volunteers
Aarhus University Hospital · Sites in Germany, Denmark, Norway and 2 more countries
Ages 50+
Universitätsklinikum Hamburg-Eppendorf · Sites in Germany
Ages 70+
Bristol-Myers Squibb · Sites in Germany, United States, Argentina and 14 more countries
Ages 60–85
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 383 Dementia studies recruiting now, 244 (64%) set no upper age limit and 25 (7%) stop at 75 or younger; 16 take children under 18; 164 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
96 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 1 · Phase 2 23 · Phase 3 32 · Phase 4 1
First in 2001; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 554 is above the median of 90 across 1,759 interventional studies indexed under Dementia.
Median enrollment 327 across the 77 interventional studies, 441 across the 18 observational. Of the 65 that completed or were terminated, 20 (31%) have results posted.
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40 of 96 have an industry lead sponsor. The 10 most frequent:
German Center for Neurodegenerative Diseases (DZNE) is the lead sponsor of 15 studies on the registry; 2 are open to participants now.
German Center for Neurodegenerative Diseases (DZNE) has 7 studies filed under Dementia — fewer than ten, so there is no comparison to draw.
1 of the studies in Dementia with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07114458Universitätsklinikum Hamburg-EppendorfDelirium and Cognitive Impairment Development in Hospitalized Older Adults Under Isolation Conditions | 2027-04 |
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Among the 96 studies in Dementia with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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In Germany, approximately 1.8 million individuals are living with dementia, representing a considerable share of those requiring long-term care. Many people with dementia (PlwD) express the desire to remain in their home environment for as long as possible. However, the progressive cognitive and physical decline associated with the disease renders caregiving increasingly time-intensive and places a substantial burden on family members. In the absence of sufficient support structures, maintaining home-based care becomes difficult, creating additional strain on the health care system.
The study aims to address these challenges through an innovative intervention. Its primary objectives are: (1) to evaluate whether a dyadic care management model, delivered by specialized nurses with expertise in dementia care and supported by a mobile health application that provides direct access to caregiving experts and memory clinics, can help stabilize the home care situation; (2) to determine whether this approach reduces caregiver burden; and (3) to assess its effectiveness in alleviating neuropsychiatric symptoms in PlwD, compared to usual care.
In Germany, approximately 84% of the five million individuals in need of care are supported at home by informal caregivers, most commonly family members. Only 21% receive professional assistance from care or support services, highlighting the substantial responsibility placed on families. People living with dementia (PlwD) constitute a particularly large share of these care recipients. On average, they require around 36 hours of informal care per week-considerably more than individuals affected by conditions such as cancer (16 hours/week) or stroke (24 hours/week).
Both PlwD and their caregivers, often conceptualized as a dyad, frequently express a strong preference for remaining in their home environment and sustaining home-based care for as long as possible. While many caregivers provide support over extended periods and may even perceive their role as meaningful, the progressive cognitive and physical decline of PlwD, combined with neuropsychiatric symptoms and caregivers' perceived sense of obligation, can result in considerable psychological and physical strain. Such strain is commonly associated with depression, anxiety, diminished subjective well-being, reduced self-efficacy, and social withdrawal. Consequently, the sustainability of home care is often precarious. Indeed, 40% of caregivers of community-dwelling PlwD report being unable to maintain care for longer than one year, leading to institutionalization.
Although support services for caregivers have been steadily expanded in recent years, their utilization remains limited. Barriers include a lack of awareness, organizational hurdles, and, paradoxically, the high demands of caregiving itself, which can hinder access to such services. In the absence of sufficient support, informal care is increasingly substituted by professional long-term care, thereby intensifying pressure on already limited workforce and financial resources within the health care system. This transition is also frequently accompanied by feelings of guilt among caregivers.
Evidence regarding the effectiveness of interventions to support caregivers is mixed. Randomized controlled trials have only partly demonstrated significant reductions in caregiver burden. A meta-analysis indicated that individualized, structured multicomponent interventions-comprising various support modules-are most effective. While there is some evidence for cost-effectiveness, it is constrained by small sample sizes. A model-based analysis suggests that dyadic interventions, which target both PlwD and caregivers, may prolong the feasibility of home-based care and could be cost-effective. However, findings remain inconsistent: a meta-analysis of randomized controlled trials reported positive outcomes in 13 studies but no effect in 9 others. Effectiveness appears to depend strongly on the duration and intensity of interventions. One explanation may be that caregiver needs during periods of heightened burden were not adequately or promptly addressed.
Digital health interventions, such as remote, app-based solutions, offer the potential to overcome these limitations by providing flexible and immediate support at critical moments. Nevertheless, research in this field remains limited, and it is still unclear to what extent digital approaches can stabilize home care situations for PlwD and their families.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Care as usual
Dyads in the intervention group will receive individualized dementia care management over a twelve-month period, with the objective of identifying and effectively addressing the unmet needs of people living with dementia (PlwD) and their caregivers. The intervention is complemented by a mobile health application used by both caregivers and Care Specialists, providing caregivers with continuous access to care managers and memory clinics whenever challenges or burdens arise. The app facilitates ongoing monitoring of caregivers' health status and burden through regular realtime data collection, aggregation, and transmission to the care manager, thereby enabling timely and needs-based interventions or re-interventions. Consequently, the frequency and intensity of the intervention are tailored to the dyads' individual circumstances and reported levels of burden.
Other: Experimental arm
Dyads in the intervention group will receive individualized dementia care management over a twelve-month period, with the objective of identifying and effectively addressing the unmet needs of people living with dementia (PlwD) and their caregivers. The intervention is complemented by a mobile health application used by both caregivers and Care Specialists, providing caregivers with continuous access to care managers and memory clinics whenever challenges or burdens arise. The app facilitates ongoing monitoring of caregivers' health status and burden through regular real-time data collection, aggregation, and transmission to the care manager, thereby enabling timely and needs-based interventions or re-interventions. Consequently, the frequency and intensity of the intervention are tailored to the dyads' individual circumstances and reported levels of burden.
Also known as: Individualized Dementia Care Management
Stability of the home care arrangement (Perseverance Time Scale)
For the Perseverance Time Scale, informal caregivers are asked (self-assessment) to estimate how long they believe they can continue to provide informal care and, thus, their current care situation. Response options are: less than one week, less than one month, less than six months, less than one year, less than two years, and two years or more. This measure is central to evaluating the long-term stability of home-based care - an essential aspect of dementia care, given the chronic and progressive nature of the disease.
Time frame: 12 months after baseline assessment
Neuropsychiatric symptoms (NPI-Q)
Another primary outcome is the presence of neuropsychiatric symptoms in PlwD, assessed with the Neuropsychiatric Inventory Questionnaire (NPI-Q), completed by the informal caregiver via face-to-face interviews with the study nurse. Neuropsychiatric symptoms are well-documented contributors to caregiver burden, underlining the dyadic nature of selected primary outcomes. Each of the 12 domains of the NPI-Q includes a survey item that captures the key symptom associated with that domain. For each question, respondents indicate whether the symptom has been present ("Yes") or absent ("No"). If the response is "No," the informant proceeds to the next item. If "Yes," they are asked to rate the severity of the symptom experienced during the past month on a 3-point scale, as well as the caregiver distress caused by the symptom on a 5-point scale. The NPI score can becalculated by adding the scores of the first 10 ir 12 items, higher scores indicate higher presence of psychopathology.
Time frame: 12 months after baseline assessment
Caregiver burden (ZBI)
The third primary outcome is the caregiver burden itself, measured via the Zarit Burden Interview (12-item version), which will be self-completed by caregivers. This tool is among the most commonly applied instruments in informal dementia caregiver research, enabling comparability across studies. While the most commonly used form of the Zarit Burden Interview is a 22-item version, the shortened 12-item version has demonstrated comparable psychometric properties (Bedard et al., 2001), offering a time-efficient alternative that reduces respondent burden. Each item on the interview is a statement which the caregiver is asked to rate using a 5-point scale. Response options range from 0 (never) to 4 (nearly always). The result of the instrument is a sum between 0 and 48, higher results indicate a higher subjective level of burden.
Time frame: 12 months after baseline assessment
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Plan to share: No
Started Jan 2026 (actual). Primary completion is estimated for Jun 2028, 29 months after the start.
Of 858 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 29 months is above that.
Counting every sponsor, half of 904 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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German Center for Neurodegenerative Diseases (DZNE)