An observational study in Mild Cognitive Disorder, Alzheimer Disease and Vascular Dementia, sponsored by University of Erlangen-Nürnberg Medical School. Recruiting at 12 sites in Germany. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Erlangen-Nürnberg Medical School · Observational
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 2nd largest by planned enrollment of the 18 observational ones that give a count, is one of 4 that started in 2020, is one of 18 observational ones, reaches primary completion later than 14 of the 17 other live ones, and was the 96th registered.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 256 across 553 observational studies indexed under Dementia.
Browse Dementia studies →13 of the 96 studies in Dementia with a site in Germany are open now.
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 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: all sexes · no healthy volunteers.
The full table on the hub →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. 4 started in 2020.
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.
40 of 96 have an industry lead sponsor. The 10 most frequent:
University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.
University of Erlangen-Nürnberg Medical School has 1 study 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 |
Among the 96 studies in Dementia with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
Around 57 million people worldwide live with dementia, with approximately 10 million new cases diagnosed each year. By the end of 2023, around 1.8 million people were living with dementia in Germany, the majority of whom were over 65 years of age (1.7 million). In Bavaria, around 257,000 people were living with dementia in 2023. Providing care and support for these people in the future is one of the biggest challenges not only for the healthcare system, but also for society as a whole. This is particularly true when it comes to caring for people with dementia in rural areas.
The Digital Dementia Registry Bavaria (digiDEM Bayern) is a health outcomes research project that aims to improve understanding of the clinical complexity, long-term progression, and care situation of dementia.
digiDEM Bayern is a multicenter longitudinal study conducted in all administrative districts of Bavaria. Participants from both urban and rural areas are included. Participants are people with mild cognitive impairment (MCI) and people with mild to moderate dementia (defined according to ICD-10: F06.7, F00-F03) who are cared for at home by their family caregivers, as well as the family caregivers themselves.
Prior to study enrollment, participants with cognitive impairments are assessed for their suitability for the study using brief cognitive tests (Mini Mental State Examination, Montreal Cognitive Assessment). Participants are then interviewed at several points in time (baseline, after 6 months, after 12 months, annually) on the basis of standardized, face-to-face interviews. Participation is voluntary. As part of the informed consent process, participants will be informed about the project in advance and asked to consent to participate in the study.
Participants are recruited in all administrative districts in Bavaria. Participants are recruited and surveyed through institutions that are active in counseling, care, diagnosis, treatment, and care for people with dementia, including counseling facilities, care groups, and residential communities, as well as outpatient (memory clinics, outpatient care services, general practitioners and specialists), inpatient (acute care hospitals, district clinics, geriatric rehabilitation facilities) and semi-inpatient (geriatric day clinics, day care facilities) institutions.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 256 across 553 observational studies indexed under Dementia.
Browse Dementia studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.
Compared within Dementia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neurocognitive Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Participants are recruited and surveyed through institutions that are active in counseling, care, diagnosis, treatment, and care for people with dementia, including counseling facilities, care groups, and residential communities, as well as outpatient (memory clinics, outpatient care services, general practitioners and specialists), inpatient (acute care hospitals, district clinics, geriatric rehabilitation facilities) and semi-inpatient (geriatric day clinics, day care facilities) institutions
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People with mild cognitive impairment and people with dementia
Family caregivers of the people with cognitive impairments
Postal code
Time frame: Baseline
Age
in years
Time frame: Baseline
Gender
Time frame: Baseline
Country of birth
Time frame: Baseline
Parents' country of birth
Time frame: Baseline
Most often spoken language in the household
Time frame: Baseline
Religion
Time frame: Baseline
Education
Time frame: Baseline
Vocational training
Time frame: Baseline
Employment status
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Marital status
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Number of children
in general and those, who live in the same household
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Number of persons living in the household
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Relationship between the person with cognitive impairment and the family caregiver
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Living arrangements
Which kind of living arrangement (own home environment, assisted living, shared apartment, others) and who are the people, who live in this arrangement (family caregiver, spouse, children, siblings, others)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Powers of attorney and guardianship
Existence of a power of attorney for health care, a living will, and legal guardianship (Vorsorgevollmacht, Patientenverfügung, gesetzliche Betreuung)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Severe disability
Does a person with cognitive impairments have a severe disability? (according to German law)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Name of the health insurance company
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Monthly net income
in Euro and in categories (e.g. 0-1000€)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Use of care leave
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Time of onset of the first symptoms
as date
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Dementia diagnosis
according to ICD-10
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Time of diagnosis
as date
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Age at the time of diagnosis
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Person, who initiated the diagnostic evaluation
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Facility, where the diagnosis was made
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Specialist who made the diagnosis
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Charlson Comorbidity Index (CCI)
Total Score Range: 0-32 (without dementia), higher values indicate a worse (greater) comorbid disease burden, data collected only at memory-clinics
Time frame: Baseline
Risk factors
data collected only at memory-clinics
Time frame: Baseline
Measures that were used for diagnostic evaluation
medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics
Time frame: Baseline
Consortium to Establish a Registry for Alzheimer's Disease (CERAD)
Higher values indicate better cognitive performance, data collected only at memory-clinics
Time frame: Baseline
Mini Mental State Examination (MMSE)
Total Score Range: 0-30, higher values indicate better cognitive performance
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Montreal Cognitive Assessment (MoCA)
Total Score Range: 0-30, higher values indicate better cognitive performance
Time frame: Baseline
Barthel-Index
Total Score Range: 0-100, higher values indicate better functional independence (less disability)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Neuropsychiatric Inventory (NPI)
12 domains, each frequency (1-4) × severity (1-3), Total Score Range: 0-144, higher values indicate worse (more/severe) neuropsychiatric symptoms
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Number of falls requiring treatment in the last six months
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Tendency to wander
Is the person with cognitive impairment trying to run away from home?
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Resource Utilization in Dementia (RUD)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Dementia Assessment of Service Needs (DEMAND)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
EuroQoL 5D (EQ-5D)
Total Score Range: -0.661 to 1, higher values indicate a better health-related quality of life
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Lubben Social Network Scale (LSNS)
Total Score Range: 0-60, higher values indicate a better social network/less social isolation
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Sources of information on health topics
Internet, TV/ radio, books, courses and lectures, newspaper and magazines, family, friends and collegues, pharmacies, healthcare professional, others (measured on a Likert scale, from unimportant to very important)
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Last time, the internet was used
in categories
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Average internet usage over the past three months
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Devices that were used to access the internet
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Purposes for using the Internet
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Reasons for non-use of the internet
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Mobility
Possession of a driver's licence and active participation in traffic
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Burden Scale for Family Caregivers (BSFC)
Total Score Range: 0-30, higher values indicate a worse (greater) caregiver burden
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Benefits of Being a Caregiver Scale (BBCS)
Total Score Range: 0-50, higher values indicate a better (more) perceived benefits from caregiving
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Short Form 12 Health Survey (SF-12)
Physical health and mental health summary scores, Total Score Range: 0-100, norm based scoring, higher values indicate a better physical/mental health status
Time frame: Baseline, after 6 months, after 12 months, after 24 months, after 36 months, after 48 months, after 60 months, after 72 months, after 84 months, after 96 months, after 108 months, after 120 months
Plan to share: Yes — Researchers who wish to use data from digiDEM Bayern must submit a request to the scientific project management. The scientific project management retains the final authority to decide on access to and use of data and ensures that it is used only for scientific purposes and in the public interest. An application for access may only be submitted by researchers from Germany or other countries where the European Union's General Data Protection Regulation (GDPR) applies.
Started Aug 2020 (actual). Primary completion is estimated for Dec 2031, 136 months after the start.
Of 271 non-industry observational studies under Dementia, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 202. This study's planned 136 months is above that.
Counting every sponsor, half of 293 studies reached it within 67 months; a quarter within 29 and three quarters within 188.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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