Mild Cognitive DisorderdigiDEM BayernNCT07721701
Digital Dementia Registry Bavaria (digiDEM Bayern): a Multicentre, Prospective, Longitudinal Register Study Including People With Mild Cognitive Impairment and Dementia as Well as Their Family Caregivers
An observational study of Mild Cognitive Disorder and Alzheimer Disease, run by University of Erlangen-Nürnberg Medical School at 12 sites in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Disorder, Alzheimer Disease, Vascular Dementia
- How many people
- 5,000 participants
- Where
- 12 sitesGermany
- Study dates
- 10 Aug 2020to 31 Dec 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- People with an MMSE score of 24-30 points and an additional MoCA score of 0-23 points
- People with an MMSE score of 15-23 points
- Living in a home environment
- All types of MCI and dementia according to the ICD-10 classification (F06.7, F00-F03)
- Main residence in Bavaria
- All age groups
Who cannot join
- People with an MMST score of 24-30 points and an additional MoCA score of 24-30 points
- People with an MMST score of 0-14 points
- Permanent residence in a nursing home
- Psychiatric diagnoses (among others depression, schizophrenia, addiction)
- Deafness and/or blindness
- Aphasia
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med. contact
12 sites in 1 country
Germany12 sites, 12 recruiting
- Recruiting
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, 63739
Jan Dorr, Dr. med., +49 6021 32-3062, geriatrie@klinikum-ab-alz.de
- Recruiting
Schön Klinik Bad Aibling
Bad Aibling, 83043
Klaus Jahn, Prof. Dr., +49 8061 903-0, kljahn@schoen-klinik.de
- Recruiting
RHÖN-KLINIKUM Campus Bad Neustadt
Bad Neustadt an der Saale, 97616
Renate Weinhardt, +49 9771 66-24335, renate.weinhardt@campus-nes.de
- Recruiting
Klinikum Bayreuth
Bayreuth, 95445
Thomas Tümena, +49 921 400-6680, thomas.tuemena@klinikum-bayreuth.de
- Recruiting
Klinikum Coburg, Regiomed Zentrum für Altersmedizin
Coburg, 96450
Johannes Kraft, Prof. Dr. med., +49 9561 22-7304, johannes.kraft@klinikum-coburg.de
- Recruiting
Kliniken Am Goldenen Steig
Freyung, 94078
Thomas Motzek-Noé, Dr. med., +49 8551 977-1160, KD@frg-kliniken.de
- Recruiting
Marion von Tessin Memory-Zentrum
München, 80335
Eva Demmel, +49 89 21 54321-0, e.demmel@mvt-zentrum.de
- Recruiting
Schön Klinik München Schwabing
München, 80804
Jürgen Herzog, Dr., +49 89 36087-132, jherzog@schoen-klinik.de
- Recruiting
Klinikum Neumarkt
Neumarkt, 92318
Martin Ritt, Prof. Dr. med. habil. Dr. med., +49 9181 420-3076, martin.ritt@klinikum.neumarkt.de
- Recruiting
Klinikum Nürnberg
Nuremberg, 90419
Lea Bräuer, +49 911 398-3943, gedaechtnissprechstunde@klinikum-nuernberg.de
- Recruiting
Klinik und Poliklinik für Psychiatrie Regensburg
Regensburg, 93053
Stefan Werner, Dr. med., +49 941 941-1221, gedaechtnis-psy-r@medbo.de
- Recruiting
Böhm-Peters - Praxis für Psychiatrie, Psychotherapie und Neurologie
Rosenheim, 83022
Henning Peters, Dr. Dr. med., +49 8031 2213-000, sbp@kns-rosenheim.de
About this study
Official title: Digital Dementia Registry Bavaria (digiDEM Bayern)
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.
Read more
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.
- Conditions
- Mild Cognitive Disorder, Alzheimer Disease, Vascular Dementia, Dementia in Other Diseases Classified Elsewhere, Unspecified Dementia
- Keywords
- MCI, Dementia, Registry, Digital, Alzheimers Disease
- Medical subject headings
- Neurocognitive Disorders, Alzheimer Disease, Dementia, Vascular, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with cognitive impairments | People with mild cognitive impairment and people with dementia | |
| Family caregivers | Family caregivers of the people with cognitive impairments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postal code
Measured: Baseline
Age
in years
Measured: Baseline
Gender
Measured: Baseline
Country of birth
Measured: Baseline
Parents' country of birth
Measured: Baseline
Most often spoken language in the household
Measured: Baseline
Religion
Measured: Baseline
Education
Measured: Baseline
Vocational training
Measured: Baseline
Employment status
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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€)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Risk factors
data collected only at memory-clinics
Measured: Baseline
Measures that were used for diagnostic evaluation
medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics
Measured: Baseline
Consortium to Establish a Registry for Alzheimer's Disease (CERAD)
Higher values indicate better cognitive performance, data collected only at memory-clinics
Measured: Baseline
Mini Mental State Examination (MMSE)
Total Score Range: 0-30, higher values indicate better cognitive performance
Measured: 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
Measured: Baseline
Barthel-Index
Total Score Range: 0-100, higher values indicate better functional independence (less disability)
Measured: 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
Measured: 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
Measured: 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?
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start10 Aug 2020
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
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 Mild Cognitive DisorderStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Erlangen-Nürnberg, Medical Valley EMN e. V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721701
- Sponsor's protocol ID
- 253_20 B
- Other IDs
- G42d-G8300-2017/1606-1110, DRKS00038679
- Acronym
- digiDEM Bayern
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Dietzel N, Kurten L, Karrer L, Reichold M, Kohler L, Nagel A, Chmelirsch C, Seebahn K, Hladik M, Meuer S, Kirchner A, Holm K, Selau M, Wendel M, Trinkwalter J, Prokosch HU, Graessel E, Kolominsky-Rabas PL. Digital Dementia Registry Bavaria-digiDEM Bayern: study protocol for a multicentre, prospective, longitudinal register study. BMJ Open. 2021 Feb 8;11(2):e043473. doi: 10.1136/bmjopen-2020-043473.
PubMed 33558357Reichold M, Dietzel N, Chmelirsch C, Kolominsky-Rabas PL, Graessel E, Prokosch HU. Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern. Appl Clin Inform. 2021 May;12(3):551-563. doi: 10.1055/s-0041-1731286. Epub 2021 Jun 16.
PubMed 34134149
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Dementia Registry Bavaria (digiDEM Bayern)
- ClinicalTrials.gov ID
- NCT07721701
- Acronym / sponsor ID
- digiDEM Bayern / 253_20 B
- Conditions
- Mild Cognitive Disorder, Alzheimer Disease, Vascular Dementia, Dementia in Other Diseases Classified Elsewhere, Unspecified Dementia
- Keywords
- MCI, Dementia, Registry, Digital, Alzheimers Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- University of Erlangen-Nürnberg, Medical Valley EMN e. V.
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 23 Jul 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with cognitive impairments | – | –People with mild cognitive impairment and people with dementia |
| Family caregivers | – | –Family caregivers of the people with cognitive impairments |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (6 listed)
- People with an MMSE score of 24-30 points and an additional MoCA score of 0-23 points
- People with an MMSE score of 15-23 points
- Living in a home environment
- All types of MCI and dementia according to the ICD-10 classification (F06.7, F00-F03)
- Main residence in Bavaria
Key exclusion criteria (6 listed)
- People with an MMST score of 24-30 points and an additional MoCA score of 24-30 points
- People with an MMST score of 0-14 points
- Permanent residence in a nursing home
- Psychiatric diagnoses (among others depression, schizophrenia, addiction)
- Deafness and/or blindness
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
Postal code
Time frame: Baseline
Age
Time frame: Baseline
in years
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
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
in general and those, who live in the same household
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
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
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)
Powers of attorney and guardianship
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
Existence of a power of attorney for health care, a living will, and legal guardianship (Vorsorgevollmacht, Patientenverfügung, gesetzliche Betreuung)
Severe 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
Does a person with cognitive impairments have a severe disability? (according to German law)
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
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
in Euro and in categories (e.g. 0-1000€)
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
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
as date
Dementia 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
according to ICD-10
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
as date
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)
Time frame: Baseline
Total Score Range: 0-32 (without dementia), higher values indicate a worse (greater) comorbid disease burden, data collected only at memory-clinics
Risk factors
Time frame: Baseline
data collected only at memory-clinics
Measures that were used for diagnostic evaluation
Time frame: Baseline
medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics
Consortium to Establish a Registry for Alzheimer's Disease (CERAD)
Time frame: Baseline
Higher values indicate better cognitive performance, data collected only at memory-clinics
Mini Mental State Examination (MMSE)
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
Total Score Range: 0-30, higher values indicate better cognitive performance
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline
Total Score Range: 0-30, higher values indicate better cognitive performance
Barthel-Index
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
Total Score Range: 0-100, higher values indicate better functional independence (less disability)
Neuropsychiatric Inventory (NPI)
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
12 domains, each frequency (1-4) × severity (1-3), Total Score Range: 0-144, higher values indicate worse (more/severe) neuropsychiatric symptoms
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
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
Is the person with cognitive impairment trying to run away from home?
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)
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
Total Score Range: -0.661 to 1, higher values indicate a better health-related quality of life
Lubben Social Network Scale (LSNS)
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
Total Score Range: 0-60, higher values indicate a better social network/less social isolation
Sources of information on health topics
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
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)
Last time, the internet was used
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
in categories
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
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
Possession of a driver's licence and active participation in traffic
Burden Scale for Family Caregivers (BSFC)
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
Total Score Range: 0-30, higher values indicate a worse (greater) caregiver burden
Benefits of Being a Caregiver Scale (BBCS)
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
Total Score Range: 0-50, higher values indicate a better (more) perceived benefits from caregiving
Short Form 12 Health Survey (SF-12)
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
Physical health and mental health summary scores, Total Score Range: 0-100, norm based scoring, higher values indicate a better physical/mental health status
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 33558357Dietzel N, Kurten L, Karrer L, Reichold M, Kohler L, Nagel A, Chmelirsch C, Seebahn K, Hladik M, Meuer S, Kirchner A, Holm K, Selau M, Wendel M, Trinkwalter J, Prokosch HU, Graessel E, Kolominsky-Rabas PL. Digital Dementia Registry Bavaria-digiDEM Bayern: study protocol for a multicentre, prospective, longitudinal register study. BMJ Open. 2021 Feb 8;11(2):e043473. doi: 10.1136/bmjopen-2020-043473.
- Background: PubMed 34134149Reichold M, Dietzel N, Chmelirsch C, Kolominsky-Rabas PL, Graessel E, Prokosch HU. Designing and Implementing an IT Architecture for a Digital Multicenter Dementia Registry: digiDEM Bayern. Appl Clin Inform. 2021 May;12(3):551-563. doi: 10.1055/s-0041-1731286. Epub 2021 Jun 16.
- Official project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med. contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Disorder and Alzheimer Disease, run by University of Erlangen-Nürnberg Medical School at 12 sites in Germany.
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 6 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med. (+49 9131 85-35855, peter.kolominsky-rabas@fau.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postal code (time frame: Baseline). The study lists 51 primary outcomes in all. 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 NCT07721701, 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 23 Jul 2026.