Age-related Cognitive DeclineDVSNCT05155397
The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability
An observational study of Age-related Cognitive Decline, run by Technical University of Dortmund at 1 site in Germany.
Trial summary
The goal of the Dortmund Vital Study is to validate previous hypotheses and to generate and validate new hypotheses about the relationship of ageing, working conditions, genetic makeup, stress, metabolic functions, cardiovascular system, immune system, and mental performance over the lifespan with a focus on healthy… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- How many people
- 627 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 2037
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals from the general population.
Who may be able to join
- Blood thinners
- Hormones
- Antihypertensives
- Cholesterol reducers
- Normal or corrected-to-normal vision and hearing
- Fulfill standard inclusion criteria for MRI measurements
- Sufficient language skills
Who cannot join
- Dementia
- Parkinsonism
- Stroke
- Cardiovascular diseases
- Bleeding tendency
- Oncological diseases
Show all 17Show fewer
- Schizophrenia
- Obsessive-compulsive disorder
- Anxiety disorders
- Severe depression
- Head injuries
- Head surgery
- Head implants
- Eye diseases (cataract, glaucoma, blindness)
- Accidents that limit physical fitness and mobility
- Psychotropic drugs
- Neuroleptics
Trial locations and contacts
1 site in 1 country.
Germany1 site
Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors
Dortmund, 44139
About this study
Official title: The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability Across the Lifespan. An Interdisciplinary, Cross-sectional and Longitudinal Study
The goal of the Dortmund Vital Study is to validate previous hypotheses and to generate and validate new hypotheses about the relationship of ageing, working conditions, genetic makeup, stress, metabolic functions, cardiovascular system, immune system, and mental performance over the lifespan with a focus on healthy working adults. The Dortmund Vital Study is a multidisciplinary longitudinal study involving the Departments of Ergonomics, Immunology, Psychology and Neurosciences, and Toxicology of the Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo) in Dortmund, Germany, as well as several national and international cooperation partners.
Read the detailed description
The Dortmund Vital Study is designed as a combined cross-sectional and longitudinal study. About 600 subjects aged between 20 and 70 years will participate. A wide range of demographic, psychological, behavioral, sensory, cardiovascular, biochemical, immunological and biochemical data, a comprehensive EEG-based cognitive test battery as well as structural and functional magnetic resonance imaging (MRI) have been included in the study. Specifically, parameters obtained by MRI and EEG-related measures can be evaluated as a function of polygenic scores, metabolic products, concentration of immune cells, immune age and infections, such as Toxoplasmosis or COVID-19 that are largely unexplored. The same is true for environmental and lifestyle factors that impact on brain activity and behavior.
The initial testing has been conducted between 2016 and 2021 and will be repeated every five years (three follow-up measures until 2035).
The study will shed light on sources of large inter-individual differences in cognitive functioning with increasing age and reveal biological and lifestyle markers contributing to work ability, longevity and healthy aging on the one hand, and on risk factors for cognitive decline, mild cognitive impairment or even dementia on the other.
- Conditions
- Age-related Cognitive Decline
- Keywords
- Cognitive Ageing, Occupational Health, Neuropsychology, Metabolism, Cardiovascular System, Behavioral Genetics, Immunology, EEG, MRI, psychoneuroendocrinology, Infectious diseases, Cognitive Neuroscience
- Medical subject headings
- Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in performance on global cognitive composite score assessed by neuropsychological tests
Change in performance on global cognitive composite score based on measures from neuropsychological tests: Digit-Span forward and backward, semantic memory in written and spoken versions (Word-Fluency), selective attention and attentional endurance (D2-R), crystallized intelligence (Multiple Choice Vocabulary Test), general cognitive status (Mini-Mental-State-Examination; MMSE), different aspects of verbal memory like learning performance and retrieval (Verbal Learning and Memory Tests; VLMT), psychomotor performance and speed of processing (Digit-Symbol-Test), interference control and inhibition (Stroop Test), task switching (Trail-Making-Test; TMT-A and TMT-B), two subtests from the performance testing system measuring logical reasoning and spatial rotation, and fluid intelligence assessed by Raven's Progressive Matrices.
Measured: Baseline and 5, 10, 15 years
Change in attentional performance and perceptual control as assessed by a computerized Bar Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in attentional performance and perceptual control assessed by the Bar Task.
Measured: Baseline and 5, 10, 15 years
Change in vigilance control as assessed by a computerized Psychomotor Vigilance Test
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in a Psychomotor Vigilance Test.
Measured: Baseline and 5, 10, 15 years
Change in stimulus-response compatibility and conflict processing assessed by the computerized Simon Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Simon task.
Measured: Baseline and 5, 10, 15 years
Change in updating and strategy learning assessed by the computerized AX-CPT Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the AX-CPT task.
Measured: Baseline and 5, 10, 15 years
Change in speech understanding and auditory distractibility assessed by computerized Speech-In-Noise perception task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Speech-in-noise perception task.
Measured: Baseline and 5, 10, 15 years
Change in working memory assessed by the computerized N-back Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the N-back task.
Measured: Baseline and 5, 10, 15 years
Change in cue and memory-based task switching assessed by the computerized Task Switching Paradigm
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the cue- and memory based task switching.
Measured: Baseline and 5, 10, 15 years
Change in auditive attention and distractibility assessed by the computerized Auditory Distraction Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Auditory Distraction Task.
Measured: Baseline and 5, 10, 15 years
Change in susceptibility to interference and the capacity to inhibit irrelevant stimuli assessed by the computerized Stroop Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Stroop Task.
Measured: Baseline and 5, 10, 15 years
Change in inhibitory control of prepotent responses assessed by the computerized Go/NoGo Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Go/NoGo Task.
Measured: Baseline and 5, 10, 15 years
Change in spatial selective attention assessed by the computerized Visual Search Task
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Visual Search Task.
Measured: Baseline and 5, 10, 15 years
Change in Work Ability Index
Change in work ability assessed by Work Ability Index (WAI). WAI assess physical and psychological risks to avoid work-related disabilities and early retirement. The index is determined by the employees' answers related to work demands, individual health status and physical and psychological capacities. The total score of WAI is calculated by summing up scores of seven dimensions. The work ability ranged between 7 (insufficient) and 49 points (best work ability).
Measured: Baseline and 5, 10, 15 years
Secondary outcomes (27)
Change in resting state EEG activity
Change in resting state EEG activity measured for 2 minutes with eyes open, and 2 minutes with eyes closed.
Measured: baseline and 5, 10, 15 years
Change in brain function MRI
Changes in functional magnetic resonance imaging assessed by resting state MRI.
Measured: 5, 10, 15 years
Change in brain structure MRI
Changes in structural resonance imaging assessed by multi-shell diffusion-weighted imaging (DWI).
Measured: 5, 10, 15 years
Change in Depressive Symptoms
Change in total score using the Becks Depression Inventory (BDI).
Measured: Baseline and 5, 10, 15 years
Change in Burnout Symptoms
Change in total score using the Maslach Burnout Inventory (MBI-D) with 6-point Likert-type scale ranging from 1 (never) to 6 (always), total scores: 14 - 84. Higher scores indicate more severe symptoms.
Measured: Baseline and 5, 10, 15 years
Change in Burnout Symptoms
Change in total score using the Oldenburg Burnout Inventory (OLBI). 4-point Likert-type scale ranging from 1 (strongly agree) to 4 (strongly disagree), total scores: 8 - 32. Higher scores indicate more severe symptoms.
Measured: Baseline and 5, 10, 15 years
Change in Psychosocial Stress Symptoms
Change in total score using the Psychosocial Stress Questionnaire (PSQ-20).
Measured: Baseline and 5, 10, 15 years
Change in Chronic Stress Symptoms
Change in chronic stress symptoms assessed by the Trier Inventory of Chronic Stress (TICS), consisting of several dimensions: Work Overload, Social Overload, Pressure to Perform, Work Discontent, Demands from work, Lack of Social Recognition, Social Tensions, Social Isolation, Chronic Worrying, and a 12 Item Screening-Scale (SSCS) that provides a score for general stress.
Measured: Baseline and 5, 10, 15 years
Change in Psychosocial Work Demands
Change in total score in the Copenhagen Psychosocial Questionnaire (COPSOQ III) that consists of several dimensions: cognitive and physical demands at work, job control, influence at work, developmental possibilities, interpersonal relations, leadership, and strain.
Measured: 5, 10, 15 years
Change in Self-Control at work
Change of the psychosocial demands at work assessed by the scale Self-Control at Work.
Measured: Baseline and 5, 10, 15 years
Change in Cognitive Failures in the Daily Life
Change in cognitive failures in daily life assessed by the Cognitive Failure Questionnaire (CFQ).
Measured: Baseline and 5, 10, 15 years
Change in Positive and Negative Affect
Change in scores of positive and negative affect. The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect.
Measured: Baseline and 5, 10, 15 years
Change in Quality of Life
Change in total score of the quality of life questionnaire (WHOQoL-BREF), consisting of dimensions: physical, psychological, social, environmental, and global quality of life.
Measured: Baseline and 5, 10, 15 years
Change in sociodemographic parameters
Change in different sociodemographic aspects like marital status, occupational status, nutrition, leisure activities, alcohol drinking, frequency of social contacts, using of electronic media etc. Qualitative data will be categorized.
Measured: Baseline and 5, 10, 15 years
Change in self-reported physical activity
Change of the self-reported physical activity (Lüdenscheid Physical Activity Questionnaire) in minutes per week.
Measured: Baseline and 5, 10, 15 years
Change in lateralization and motor functions
Change in total score of the Perdue Pegboard Test, assessing lateralization and motor functions.
Measured: Baseline and 5, 10, 15 years
Change of cytokines concentration in serum
Change of concentration of cytokines in serum (pg/ml): (IL-1b, IFN-alpha, IFN-gamma, TNF-alpha, MCP-1, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33).
Measured: Baseline and 5, 10, 15 years
Change of functional activiy of T cells and Natural Killer cells
Change of functional activities of T cells and natural killer cells in %.
Measured: Baseline and 5, 10, 15 years
Change of peripheral blood mononuclear cells concentration
Change of peripheral blood mononuclear cells concentration (pg/ml): (PBMC; CD14 positive monocytes).
Measured: Baseline and 5, 10, 15 years
Change in physical performance
Change of physical fitness assessed by bicycle ergometer and a physical work capacity cycle test (PWC-130) to predict the absolute power output (in Watt) at a projected heart rate of 130 beats per minute. A relative power output is calculated by the power-to-weight ratio (Watt/kg).
Measured: Baseline and 5, 10, 15 years
Change in cardiovascular parameters
Diastolic and systolic blood pressure (mm/Hg) and pulse (bpm) measured during rest and during cycle ergometry.
Measured: Baseline and 5, 10, 15 years
Change in electrocardiography
Change in electrocardiogram (ECG) measured during rest and during cycle ergometry.
Measured: Baseline and 5, 10, 15 years
Change in antibody concentrations of Toxoplasma gondii in serum
Change of concentration of Toxoplasma gondii IgG antibodies (pg/ml) in serum to assess the severity of latent toxoplasmosis infection.
Measured: Baseline and 5, 10, 15 years
Change in antibody concentrations of COVID-19 in serum
Concentration of COVID-19 antibodies (pg/ml) in serum to assess the intensity of immunological response to potential SARC-CoV-2 infection or response to vaccination.
Measured: 5, 10, 15 years
Change in metabolic parameters in blood
Change in metabolic parameters in serum (pg/ml): concentration of ammonia, leucocytes, erythrocytes, hematocrit, monocytes, creatinine, lymphocytes, cell volume, thrombocytes, triglycerides, cholesterol, high- and low-density lipoprotein cholesterol, glycosylated hemoglobin, glucose, C-reactive protein and creatinine are measured in venous blood.
Measured: Baseline and 5, 10, 15 years
Change of metabolic parameters in urine
Change in metabolic parameters in urine (pg/ml): concentartion of creatinine and calcium oxalate.
Measured: Baseline and 5, 10, 15 years
Change of endocrine parameter
Change of hair cortisol concentration (pg/mg) as an index of long-term stress.
Measured: Baseline and 5, 10, 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study startApr 2016
- Primary completionDec 2035 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- 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
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Dortmund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edmund Wascher, PhD, Study director, Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155397
- Sponsor's protocol ID
- A93-3
- Acronym
- DVS
- Status last verified
- Sep 2026
- First submitted
- 16 Nov 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After primary analyses and publication of the main results the data and the scripts used for data analyses will be made available in repositories for secondary analyses. The transfer agreement will be prepared by the coordinators of the Dortmund Vital Study in consultation with the IfADo Research Data Management Unit.
Publications
Schwaba T, Clapp Sullivan ML, Akingbuwa WA, Ilves K, Tanksley PT, Williams CM, Dragostinov Y, Mallard TT, Tubbs JD, Liao W, Ackerman LS, Fealy JCM, Hemani G, de la Fuente J, Smith GD, Gupta P, Stein MB, Gelernter J, Levey DF, Vosa U, Ausmees L, Realo A; Estonian Biobank Research Team; Vaht M, Allik J, Esko T, Mottus R, Vainik U, Jonsdottir GA, Thorleifsson G, Gunnarsson AF, Bjornsdottir G, Thorgeirsson TE, Stefansson H, Stefansson K, Cheesman R, Qin Q, Corfield EC, Ask H, Torvik FA, Ystrom E, Tesli M, Boomsma DI, de Geus EJC, Hottenga JJ, Melo DC, Snieder H, Hartman CA, Xia C, Campbell A, Luciano M, Deary IJ, Hill WD, Jang SK, Vrieze SI, Abecasis G, Lupton MK, Mitchell BL, Viher PV, Colodro-Conde L, Martin NG, Medland SE, Derks EM, Wormington B, Kaprio J, Silventoinen K, Palviainen T, Musial A, Rimfeld K, Plomin R, Malanchini M, Dick DM, Aliev F; COGA Collaborators; Spit for Science Working Group; Wesseldijk LW, Ullen F, Mosing MA, Kranzler HR, Nunez Y, Beck S, Polimanti R, Edwards T, Giannelis A, Willoughby EA, Lee JJ, McGue M, Terracciano A, Marongiu M, Fiorillo E, Cucca F, Sutin AR, van der Most PJ, Oldehinkel AJ, Kretschmer T, Shabalin AA, Docherty AR, Krueger RF, Freilich CD, Mishra BH, Lehtimaki T, Raitakari OT, Kahonen M, Saarinen A, Dobewall H, Keltikangas-Jarvinen L, Berger K, Herrera-Rivero M, Streit F, Awasthi S, Witt SH, Tuhkanen J, Raikkonen K, Eriksson JG, Lahti J, Davies G, Redmond P, Taylor A, Corley J, Russ TC, Ciullo M, Nutile T, Ding J, Qian Y, Tanaka T, Ferrucci L, Zillich L, Sirignano L, Harden KP, Genc E, Gajewski PD, Getzmann S, Fraenz C, Schneider Penate JE, Lis S, Hall ASM, Schmahl C, Herpertz SC, Abdellaoui A, Nivard MG, Tucker-Drob EM. Robust inference and correlates from genetic associations with personality. Nature. 2026 Sep 2:10.1038/s41586-026-10992-9. doi: 10.1038/s41586-026-10992-9. Online ahead of print.
PubMed 42686911Mundorf A, Merklein SA, Reinke P, Peterburs J, Getzmann S, Gajewski PD, Larra M, Wascher E, Ocklenburg S. Effects of motor activity versus cognitive demand on asymmetries in EEG frequency bands and their relation to handedness. Front Hum Neurosci. 2026 Jul 8;20:1796350. doi: 10.3389/fnhum.2026.1796350. eCollection 2026.
PubMed 42487830Metzler YA, Schade HM, Nitsche MA, Wascher E, Getzmann S, Gajewski PD, Melo L. Beyond composite scores in chronotype assessment: item-level predictive patterns in the Morningness-Eveningness Questionnaire. Sci Rep. 2026 Jun 4;16(1):17347. doi: 10.1038/s41598-026-54301-w.
PubMed 42243262Jungeblut HM, Genc E, Burke M, Gajewski PD, Getzmann S, Wascher E, Schubert AL. The latent organization of white matter microstructure and its relation to fluid intelligence. Imaging Neurosci (Camb). 2026 Mar 19;4:IMAG.a.1167. doi: 10.1162/IMAG.a.1167. eCollection 2026.
PubMed 41868967Sabo M, Varlet M, Wascher E, Gajewski PD, Grootswagers T. Multiple partially overlapping neural modules orchestrate conflict processing. Imaging Neurosci (Camb). 2026 Feb 20;4:IMAG.a.1135. doi: 10.1162/IMAG.a.1135. eCollection 2026.
PubMed 41738010Brode P, Claus M, Getzmann S, Golka K, Hengstler JG, Reinders J, Wascher E, Watzl C, Gajewski PD. Latent Toxoplasma gondii Infection Does Not Modulate Immune Aging in a Cross-Sectional Working-Age Population Study. Biomolecules. 2025 Dec 30;16(1):55. doi: 10.3390/biom16010055.
PubMed 41594595Engler R, Stammen C, Arnau S, Schneider Penate J, Metzen D, Digutsch J, Gajewski PD, Getzmann S, Fraenz C, Reinders J, Voelkle MC, Streit F, Ocklenburg S, Schneider D, Burke M, Hengstler JG, Watzl C, Nitsche MA, Kumsta R, Wascher E, Genc E. Electrophysiological resting-state signatures link polygenic scores to general intelligence. Sci Rep. 2025 Nov 21;15(1):41170. doi: 10.1038/s41598-025-26778-4.
PubMed 41272243Gajewski PD, Brode P, Claus M, Golka K, Hengstler JG, Reinders J, Watzl C, Wascher E, Getzmann S. Changes of cognitive functions and proinflammatory cytokines across the lifespan in latent Toxoplasma gondii infection. Brain Behav Immun Health. 2025 Sep 15;49:101105. doi: 10.1016/j.bbih.2025.101105. eCollection 2025 Nov.
PubMed 41018675Gajewski PD, Brode P, Claus M, Golka K, Hengstler JG, Watzl C, Wascher E, Getzmann S. The association between hair cortisol and burnout is moderated by age, psychosocial, and immunological markers. Brain Behav Immun Health. 2024 Nov 23;43:100909. doi: 10.1016/j.bbih.2024.100909. eCollection 2025 Feb.
PubMed 39717874Kleinert T, Nash K, Koenig T, Wascher E. Correction: Normative Intercorrelations between EEG Microstate Characteristics. Brain Topogr. 2024 Mar;37(2):270. doi: 10.1007/s10548-023-01012-4. No abstract available.
PubMed 37861818Kleinert T, Nash K, Koenig T, Wascher E. Normative Intercorrelations Between EEG Microstate Characteristics. Brain Topogr. 2024 Mar;37(2):265-269. doi: 10.1007/s10548-023-00988-3. Epub 2023 Jul 14.
PubMed 37450085Kleinert T, Koenig T, Nash K, Wascher E. On the Reliability of the EEG Microstate Approach. Brain Topogr. 2024 Mar;37(2):271-286. doi: 10.1007/s10548-023-00982-9. Epub 2023 Jul 6.
PubMed 37410275Getzmann S, Arnau S, Gajewski PD, Wascher E. Auditory distraction, time perception, and the role of age: ERP evidence from a large cohort study. Neurobiol Aging. 2024 Dec;144:114-126. doi: 10.1016/j.neurobiolaging.2024.09.012. Epub 2024 Sep 20.
PubMed 39316947Getzmann S, Gajewski PD, Schneider D, Wascher E. Resting-state EEG data before and after cognitive activity across the adult lifespan and a 5-year follow-up. Sci Data. 2024 Sep 10;11(1):988. doi: 10.1038/s41597-024-03797-w.
PubMed 39256413Mundorf A, Getzmann S, Gajewski PD, Larra MF, Wascher E, Genc E, Ocklenburg S. Phenotyping in clinical laterality research: a comparison of commonly used methods to determine mixed-handedness and ambidexterity. Laterality. 2024 May;29(3):331-349. doi: 10.1080/1357650X.2024.2370871. Epub 2024 Jul 5.
PubMed 38968414
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dortmund Vital Study: Impact of Biological and Lifestyle Factors on Cognitive Performace and Work Ability Across the Lifespan. An Interdisciplinary, Cross-sectional and Longitudinal Study
- ClinicalTrials.gov ID
- NCT05155397
- Acronym / sponsor ID
- DVS / A93-3
- Conditions
- Age-related Cognitive Decline
- Keywords
- Cognitive Ageing, Occupational Health, Neuropsychology, Metabolism, Cardiovascular System, Behavioral Genetics, Immunology, EEG
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 627 participants (actual)
- Lead sponsor
- Technical University of DortmundUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 13 Dec 2021 (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.
The goal of the Dortmund Vital Study is to validate previous hypotheses and to generate and validate new hypotheses about the relationship of ageing, working conditions, genetic makeup, stress, metabolic functions, cardiovascular system, immune system, and mental performance over the lifespan with a focus on healthy working adults. The Dortmund Vital Study is a multidisciplinary longitudinal study involving the Departments of Ergonomics, Immunology, Psychology and Neurosciences, and Toxicology of the Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo) in Dortmund, Germany, as well as several national and international cooperation partners.
Detailed description
The Dortmund Vital Study is designed as a combined cross-sectional and longitudinal study. About 600 subjects aged between 20 and 70 years will participate. A wide range of demographic, psychological, behavioral, sensory, cardiovascular, biochemical, immunological and biochemical data, a comprehensive EEG-based cognitive test battery as well as structural and functional magnetic resonance imaging (MRI) have been included in the study. Specifically, parameters obtained by MRI and EEG-related measures can be evaluated as a function of polygenic scores, metabolic products, concentration of immune cells, immune age and infections, such as Toxoplasmosis or COVID-19 that are largely unexplored. The same is true for environmental and lifestyle factors that impact on brain activity and behavior.
The initial testing has been conducted between 2016 and 2021 and will be repeated every five years (three follow-up measures until 2035).
The study will shed light on sources of large inter-individual differences in cognitive functioning with increasing age and reveal biological and lifestyle markers contributing to work ability, longevity and healthy aging on the one hand, and on risk factors for cognitive decline, mild cognitive impairment or even dementia on the other.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals from the general population.
Key inclusion criteria (7 listed)
- Blood thinners
- Hormones
- Antihypertensives
- Cholesterol reducers
- Normal or corrected-to-normal vision and hearing
Key exclusion criteria (17 listed)
- Dementia
- Parkinsonism
- Stroke
- Cardiovascular diseases
- Bleeding tendency
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
Change in performance on global cognitive composite score assessed by neuropsychological tests
Time frame: Baseline and 5, 10, 15 years
Change in performance on global cognitive composite score based on measures from neuropsychological tests: Digit-Span forward and backward, semantic memory in written and spoken versions (Word-Fluency), selective attention and attentional endurance (D2-R), crystallized intelligence (Multiple Choice Vocabulary Test), general cognitive status (Mini-Mental-State-Examination; MMSE), different aspects of verbal memory like learning performance and retrieval (Verbal Learning and Memory Tests; VLMT), psychomotor performance and speed of processing (Digit-Symbol-Test), interference control and inhibition (Stroop Test), task switching (Trail-Making-Test; TMT-A and TMT-B), two subtests from the performance testing system measuring logical reasoning and spatial rotation, and fluid intelligence assessed by Raven's Progressive Matrices.
Change in attentional performance and perceptual control as assessed by a computerized Bar Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in attentional performance and perceptual control assessed by the Bar Task.
Change in vigilance control as assessed by a computerized Psychomotor Vigilance Test
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in a Psychomotor Vigilance Test.
Change in stimulus-response compatibility and conflict processing assessed by the computerized Simon Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Simon task.
Change in updating and strategy learning assessed by the computerized AX-CPT Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the AX-CPT task.
Change in speech understanding and auditory distractibility assessed by computerized Speech-In-Noise perception task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Speech-in-noise perception task.
Change in working memory assessed by the computerized N-back Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the N-back task.
Change in cue and memory-based task switching assessed by the computerized Task Switching Paradigm
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the cue- and memory based task switching.
Change in auditive attention and distractibility assessed by the computerized Auditory Distraction Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Auditory Distraction Task.
Change in susceptibility to interference and the capacity to inhibit irrelevant stimuli assessed by the computerized Stroop Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Stroop Task.
Change in inhibitory control of prepotent responses assessed by the computerized Go/NoGo Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Go/NoGo Task.
Change in spatial selective attention assessed by the computerized Visual Search Task
Time frame: Baseline and 5, 10, 15 years
Changes in behavioral (speed and accuracy) and electroencephalogram (EEG) data in the Visual Search Task.
Change in Work Ability Index
Time frame: Baseline and 5, 10, 15 years
Change in work ability assessed by Work Ability Index (WAI). WAI assess physical and psychological risks to avoid work-related disabilities and early retirement. The index is determined by the employees' answers related to work demands, individual health status and physical and psychological capacities. The total score of WAI is calculated by summing up scores of seven dimensions. The work ability ranged between 7 (insufficient) and 49 points (best work ability).
27 secondary outcomes
Change in resting state EEG activity
Time frame: baseline and 5, 10, 15 years
Change in brain function MRI
Time frame: 5, 10, 15 years
Change in brain structure MRI
Time frame: 5, 10, 15 years
Change in Depressive Symptoms
Time frame: Baseline and 5, 10, 15 years
Change in Burnout Symptoms
Time frame: Baseline and 5, 10, 15 years
Change in Burnout Symptoms
Time frame: Baseline and 5, 10, 15 years
Change in Psychosocial Stress Symptoms
Time frame: Baseline and 5, 10, 15 years
Change in Chronic Stress Symptoms
Time frame: Baseline and 5, 10, 15 years
Change in Psychosocial Work Demands
Time frame: 5, 10, 15 years
Change in Self-Control at work
Time frame: Baseline and 5, 10, 15 years
Change in Cognitive Failures in the Daily Life
Time frame: Baseline and 5, 10, 15 years
Change in Positive and Negative Affect
Time frame: Baseline and 5, 10, 15 years
Change in Quality of Life
Time frame: Baseline and 5, 10, 15 years
Change in sociodemographic parameters
Time frame: Baseline and 5, 10, 15 years
Change in self-reported physical activity
Time frame: Baseline and 5, 10, 15 years
Change in lateralization and motor functions
Time frame: Baseline and 5, 10, 15 years
Change of cytokines concentration in serum
Time frame: Baseline and 5, 10, 15 years
Change of functional activiy of T cells and Natural Killer cells
Time frame: Baseline and 5, 10, 15 years
Change of peripheral blood mononuclear cells concentration
Time frame: Baseline and 5, 10, 15 years
Change in physical performance
Time frame: Baseline and 5, 10, 15 years
Change in cardiovascular parameters
Time frame: Baseline and 5, 10, 15 years
Change in electrocardiography
Time frame: Baseline and 5, 10, 15 years
Change in antibody concentrations of Toxoplasma gondii in serum
Time frame: Baseline and 5, 10, 15 years
Change in antibody concentrations of COVID-19 in serum
Time frame: 5, 10, 15 years
Change in metabolic parameters in blood
Time frame: Baseline and 5, 10, 15 years
Change of metabolic parameters in urine
Time frame: Baseline and 5, 10, 15 years
Change of endocrine parameter
Time frame: Baseline and 5, 10, 15 years
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 2 Oct 2026.
- Results publication: PubMed 42686911Schwaba T, Clapp Sullivan ML, Akingbuwa WA, Ilves K, Tanksley PT, Williams CM, Dragostinov Y, Mallard TT, Tubbs JD, Liao W, Ackerman LS, Fealy JCM, Hemani G, de la Fuente J, Smith GD, Gupta P, Stein MB, Gelernter J, Levey DF, Vosa U, Ausmees L, Realo A; Estonian Biobank Research Team; Vaht M, Allik J, Esko T, Mottus R, Vainik U, Jonsdottir GA, Thorleifsson G, Gunnarsson AF, Bjornsdottir G, Thorgeirsson TE, Stefansson H, Stefansson K, Cheesman R, Qin Q, Corfield EC, Ask H, Torvik FA, Ystrom E, Tesli M, Boomsma DI, de Geus EJC, Hottenga JJ, Melo DC, Snieder H, Hartman CA, Xia C, Campbell A, Luciano M, Deary IJ, Hill WD, Jang SK, Vrieze SI, Abecasis G, Lupton MK, Mitchell BL, Viher PV, Colodro-Conde L, Martin NG, Medland SE, Derks EM, Wormington B, Kaprio J, Silventoinen K, Palviainen T, Musial A, Rimfeld K, Plomin R, Malanchini M, Dick DM, Aliev F; COGA Collaborators; Spit for Science Working Group; Wesseldijk LW, Ullen F, Mosing MA, Kranzler HR, Nunez Y, Beck S, Polimanti R, Edwards T, Giannelis A, Willoughby EA, Lee JJ, McGue M, Terracciano A, Marongiu M, Fiorillo E, Cucca F, Sutin AR, van der Most PJ, Oldehinkel AJ, Kretschmer T, Shabalin AA, Docherty AR, Krueger RF, Freilich CD, Mishra BH, Lehtimaki T, Raitakari OT, Kahonen M, Saarinen A, Dobewall H, Keltikangas-Jarvinen L, Berger K, Herrera-Rivero M, Streit F, Awasthi S, Witt SH, Tuhkanen J, Raikkonen K, Eriksson JG, Lahti J, Davies G, Redmond P, Taylor A, Corley J, Russ TC, Ciullo M, Nutile T, Ding J, Qian Y, Tanaka T, Ferrucci L, Zillich L, Sirignano L, Harden KP, Genc E, Gajewski PD, Getzmann S, Fraenz C, Schneider Penate JE, Lis S, Hall ASM, Schmahl C, Herpertz SC, Abdellaoui A, Nivard MG, Tucker-Drob EM. Robust inference and correlates from genetic associations with personality. Nature. 2026 Sep 2:10.1038/s41586-026-10992-9. doi: 10.1038/s41586-026-10992-9. Online ahead of print.
- Results publication: PubMed 42487830Mundorf A, Merklein SA, Reinke P, Peterburs J, Getzmann S, Gajewski PD, Larra M, Wascher E, Ocklenburg S. Effects of motor activity versus cognitive demand on asymmetries in EEG frequency bands and their relation to handedness. Front Hum Neurosci. 2026 Jul 8;20:1796350. doi: 10.3389/fnhum.2026.1796350. eCollection 2026.
- Results publication: PubMed 42243262Metzler YA, Schade HM, Nitsche MA, Wascher E, Getzmann S, Gajewski PD, Melo L. Beyond composite scores in chronotype assessment: item-level predictive patterns in the Morningness-Eveningness Questionnaire. Sci Rep. 2026 Jun 4;16(1):17347. doi: 10.1038/s41598-026-54301-w.
- Results publication: PubMed 41868967Jungeblut HM, Genc E, Burke M, Gajewski PD, Getzmann S, Wascher E, Schubert AL. The latent organization of white matter microstructure and its relation to fluid intelligence. Imaging Neurosci (Camb). 2026 Mar 19;4:IMAG.a.1167. doi: 10.1162/IMAG.a.1167. eCollection 2026.
- Results publication: PubMed 41738010Sabo M, Varlet M, Wascher E, Gajewski PD, Grootswagers T. Multiple partially overlapping neural modules orchestrate conflict processing. Imaging Neurosci (Camb). 2026 Feb 20;4:IMAG.a.1135. doi: 10.1162/IMAG.a.1135. eCollection 2026.
- Results publication: PubMed 41594595Brode P, Claus M, Getzmann S, Golka K, Hengstler JG, Reinders J, Wascher E, Watzl C, Gajewski PD. Latent Toxoplasma gondii Infection Does Not Modulate Immune Aging in a Cross-Sectional Working-Age Population Study. Biomolecules. 2025 Dec 30;16(1):55. doi: 10.3390/biom16010055.
- Results publication: PubMed 41272243Engler R, Stammen C, Arnau S, Schneider Penate J, Metzen D, Digutsch J, Gajewski PD, Getzmann S, Fraenz C, Reinders J, Voelkle MC, Streit F, Ocklenburg S, Schneider D, Burke M, Hengstler JG, Watzl C, Nitsche MA, Kumsta R, Wascher E, Genc E. Electrophysiological resting-state signatures link polygenic scores to general intelligence. Sci Rep. 2025 Nov 21;15(1):41170. doi: 10.1038/s41598-025-26778-4.
- Results publication: PubMed 41018675Gajewski PD, Brode P, Claus M, Golka K, Hengstler JG, Reinders J, Watzl C, Wascher E, Getzmann S. Changes of cognitive functions and proinflammatory cytokines across the lifespan in latent Toxoplasma gondii infection. Brain Behav Immun Health. 2025 Sep 15;49:101105. doi: 10.1016/j.bbih.2025.101105. eCollection 2025 Nov.
- Results publication: PubMed 39717874Gajewski PD, Brode P, Claus M, Golka K, Hengstler JG, Watzl C, Wascher E, Getzmann S. The association between hair cortisol and burnout is moderated by age, psychosocial, and immunological markers. Brain Behav Immun Health. 2024 Nov 23;43:100909. doi: 10.1016/j.bbih.2024.100909. eCollection 2025 Feb.
- Results publication: PubMed 37861818Kleinert T, Nash K, Koenig T, Wascher E. Correction: Normative Intercorrelations between EEG Microstate Characteristics. Brain Topogr. 2024 Mar;37(2):270. doi: 10.1007/s10548-023-01012-4. No abstract available.
- Results publication: PubMed 37450085Kleinert T, Nash K, Koenig T, Wascher E. Normative Intercorrelations Between EEG Microstate Characteristics. Brain Topogr. 2024 Mar;37(2):265-269. doi: 10.1007/s10548-023-00988-3. Epub 2023 Jul 14.
- Results publication: PubMed 37410275Kleinert T, Koenig T, Nash K, Wascher E. On the Reliability of the EEG Microstate Approach. Brain Topogr. 2024 Mar;37(2):271-286. doi: 10.1007/s10548-023-00982-9. Epub 2023 Jul 6.
- This is the oficial site of the Dortmund Vital StudyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After primary analyses and publication of the main results the data and the scripts used for data analyses will be made available in repositories for secondary analyses. The transfer agreement will be prepared by the coordinators of the Dortmund Vital Study in consultation with the IfADo Research Data Management Unit.
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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. This study is not recruiting at the moment.
Edmund Wascher, PhD study director
Leibniz Research Centre for Working Environment and Human Factors at the TU Dortmund (IfADo)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-related Cognitive Decline, run by Technical University of Dortmund at 1 site 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 7 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in performance on global cognitive composite score assessed by neuropsychological tests (time frame: Baseline and 5, 10, 15 years). The study lists 13 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 NCT05155397, which also lists 33 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 2 Oct 2026.