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 (digiDEM Bayern)

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.

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 Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Vascular Dementia; Mild Cognitive Disorder; Dementia in Other Diseases Classified Elsewhere; Unspecified Dementia

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.; Phone Number: +49 9131 85-35855; Email: peter.kolominsky-rabas@fau.de

Study Locations

• Germany
  • Aschaffenburg, Germany, 63739
    • Recruiting
    • Klinikum Aschaffenburg-Alzenau
    • Contact: Jan Dorr, Dr. med.; Phone Number: +49 6021 32-3062; Email: geriatrie@klinikum-ab-alz.de
  • Bad Aibling, Germany, 83043
    • Recruiting
    • Schön Klinik Bad Aibling
    • Contact: Klaus Jahn, Prof. Dr.; Phone Number: +49 8061 903-0; Email: kljahn@schoen-klinik.de
  • Bad Neustadt an der Saale, Germany, 97616
    • Recruiting
    • RHÖN-KLINIKUM Campus Bad Neustadt
    • Contact: Renate Weinhardt; Phone Number: +49 9771 66-24335; Email: renate.weinhardt@campus-nes.de
  • Bayreuth, Germany, 95445
    • Recruiting
    • Klinikum Bayreuth
    • Contact: Thomas Tümena; Phone Number: +49 921 400-6680; Email: thomas.tuemena@klinikum-bayreuth.de
  • Coburg, Germany, 96450
    • Recruiting
    • Klinikum Coburg, Regiomed Zentrum für Altersmedizin
    • Contact: Johannes Kraft, Prof. Dr. med.; Phone Number: +49 9561 22-7304; Email: johannes.kraft@klinikum-coburg.de
  • Freyung, Germany, 94078
    • Recruiting
    • Kliniken Am Goldenen Steig
    • Contact: Thomas Motzek-Noé, Dr. med.; Phone Number: +49 8551 977-1160; Email: KD@frg-kliniken.de
  • München, Germany, 80335
    • Recruiting
    • Marion von Tessin Memory-Zentrum
    • Contact: Eva Demmel; Phone Number: +49 89 21 54321-0; Email: e.demmel@mvt-zentrum.de
  • München, Germany, 80804
    • Recruiting
    • Schön Klinik München Schwabing
    • Contact: Jürgen Herzog, Dr.; Phone Number: +49 89 36087-132; Email: jherzog@schoen-klinik.de
  • Neumarkt, Germany, 92318
    • Recruiting
    • Klinikum Neumarkt
    • Contact: Martin Ritt, Prof. Dr. med. habil. Dr. med.; Phone Number: +49 9181 420-3076; Email: martin.ritt@klinikum.neumarkt.de
  • Nuremberg, Germany, 90419
    • Recruiting
    • Klinikum Nürnberg
    • Contact: Lea Bräuer; Phone Number: +49 911 398-3943; Email: gedaechtnissprechstunde@klinikum-nuernberg.de
  • Regensburg, Germany, 93053
    • Recruiting
    • Klinik und Poliklinik für Psychiatrie Regensburg
    • Contact: Stefan Werner, Dr. med.; Phone Number: +49 941 941-1221; Email: gedaechtnis-psy-r@medbo.de
  • Rosenheim, Germany, 83022
    • Recruiting
    • Böhm-Peters - Praxis für Psychiatrie, Psychotherapie und Neurologie
    • Contact: Henning Peters, Dr. Dr. med.; Phone Number: +49 8031 2213-000; Email: sbp@kns-rosenheim.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender		Baseline
Education		Baseline
Religion		Baseline
Age	in years	Baseline
Postal code		Baseline
Country of birth		Baseline
Parents' country of birth		Baseline
Most often spoken language in the household		Baseline
Vocational training		Baseline
Employment status		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		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	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		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		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)	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)	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)	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		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€)	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		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	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	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	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		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		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		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		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	Baseline
Risk factors	data collected only at memory-clinics	Baseline
Measures that were used for diagnostic evaluation	medical history, imaging, laboratory diagnostics, specific measures, data collected only at memory-clinics	Baseline
Consortium to Establish a Registry for Alzheimer's Disease (CERAD)	Higher values indicate better cognitive performance, data collected only at memory-clinics	Baseline
Mini Mental State Examination (MMSE)	Total Score Range: 0-30, higher values indicate better cognitive performance	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	Baseline
Barthel-Index	Total Score Range: 0-100, higher values indicate better functional independence (less disability)	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	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		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?	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)		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)		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	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	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)	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	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		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		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		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		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	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School
• Collaborators: Universitätsklinikum Erlangen; Medical Valley EMN e. V.

Publications and helpful links

General 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.
• Reichold 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.

Helpful Links

• Official project website

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: MCI; Dementia; Registry; Digital; Alzheimers Disease
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Leukoencephalopathies; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Alzheimer Disease; Dementia; Neurocognitive Disorders; Dementia, Vascular
• Other Study ID Numbers: 253_20 B; G42d-G8300-2017/1606-1110 (Other Grant/Funding Number: Bavarian State Ministry of Health, Care and Prevention); DRKS00038679 (Registry Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No