DementiaUDDGait™NCT05893524
Uppsala-Dalarna Dementia and Gait Project
An observational study of Dementia and Dementia, Mixed, run by Dalarna University at 2 sites in Sweden.
Trial summary
UDDGait™ is a multidisciplinary research project with the overreaching goal of providing an aid for early identification of cognitive impairment and risk of dementia development, thereby providing a basis for adequate symptom relieving and health promoting interventions. Read more about this study
- Who is it for?
- Ages 37 to 94 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Dementia, Mixed, Dementia Senile
- What is being tested?
- Timed Up-and-Go (TUG single-task), Timed Up-and-Go dual-task (TUGdt) and Clinical functional assessment
- How many people
- 550 participants
- Where
- 2 sitesSweden
- Study dates
- 9 Apr 2015to 24 Dec 2026
- Phase
- Observational
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 37 to 94 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients have been consecutively included when undergoing memory assessment at two specialist clinics in Sweden during the study recruitment period (April 2015 to February 2017 at Uppsala University Hospital and June 2015 to June 2016 at Falu Hospital). Age matched cognitively unimpaired community dwelling individuals without cognitive impairment were recruited through advertisements and flyers (May 2017 to March 2019 in Uppsala).
Who may be able to join
- Patients undergoing memory assessment at at Uppsala University Hospital, Sweden
- Patients undergoing memory assessment at at Falu Hospital, Sweden
- Cognitively unimpaired individuals with a Mini Mental State Examination (MMSE) score of > 26
Who cannot join
- Inability to walk three meters back and forth
- Inability to rise from a sitting position
- Indoor use of a walking aid
- Current or recent hospitalization (within the last 2 weeks)
- Need of an interpreter to communicate in Swedish
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 1 recruiting
- Completed
Dalarna University
Falun, Dalarna County, 79188
- Recruiting
Uppsala University
Uppsala, Uppsala County, 751 22
Anna Cristina Åberg, PhD, +4623778082, Anna.Cristina.Aberg@uu.se
Vilmantas Giedraitis, PhD, +46734697455, Vilmantas.Giedraitis@uu.se
About this study
UDDGait™ is a multidisciplinary research project with the overreaching goal of providing an aid for early identification of cognitive impairment and risk of dementia development, thereby providing a basis for adequate symptom relieving and health promoting interventions.
A new concept is investigated for this purpose: a "dual-task-test", which implies the combination of a well-established mobility test (Timed Up-and-Go, TUG) with a simultaneous verbal task (i.e. TUG dual-task, TUGdt). This type of test has been judged as a potential aid for early identification of dementia disease. More research is needed to further examine the test's validity, reliability and predictive capacity.
The overall aim is to investigate if TUGdt is useful as an aid for prediction of dementia disease. To ensure the results, the aim is also to evaluate the test's measurement properties and to generate normative reference values of healthy control persons.
- Conditions
- Dementia, Dementia, Mixed, Dementia Senile, Dementia of Alzheimer Type, Mild Cognitive Impairment, Subjective Cognitive Impairment
- Being tested
- Timed Up-and-Go (TUG single-task), Timed Up-and-Go dual-task (TUGdt), Clinical functional assessment
- Keywords
- Timed Up-and-Go, TUG, TUG dual-task, Cognitive tests, Dementia, Mild Cognitive Impairment, Subjective Cognitive Impairment, Alzheimer's disease, Step parameters, Video recorded tests
- Medical subject headings
- Dementia, Mixed Dementias, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timed Up-and-Go (TUG single-task)Diagnostic test
The TUG test is a well-established clinical test of one mobility sequence: rising from an armchair, walking straight ahead, passing a line marked on the floor, turning around, walking back, and sitting down again.
Timed Up-and-Go dual-task (TUGdt)Diagnostic test
Two dual-task tests including TUG (TUGdt) were carried out: TUGdt naming animals and TUGdt months backwards. The outcomes registered were: time scores for TUG single-task and both TUGdt tests, TUGdt costs (relative time difference between TUG single-task and TUGdt), number of different animals named, number of months recited in correct order, number of animals per 10 s, and number of months per 10 s.
Clinical functional assessmentDiagnostic test
The diagnostic procedure was part of the clinical routine for patients undergoing memory assessment and involved a geriatrician's careful evaluation of the patient's history and cognitive testing including Mini-Mental State Examination (MMSE), Clock Drawing Test, Verbal Fluency Test, and Trail Making Test A and B. In addition, all participants carried out short versions of the Geriatric Depression Scale and the General Motor Function Assessment Scale, as well as static balance according to the Bohannon Method, and hand grip strength using a dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing memory assessments | Patients undergoing memory assessments at two specialist memory clinics (Uppsala University Hospital in Uppsala and Falu Hospital in Falun). This group includes patients with dementia, mild cognitive impairment and subjective cognitive impairment. Receives: Diagnostic Test: Timed Up-and-Go (TUG single-task); Diagnostic Test: Timed Up-and-Go dual-task (TUGdt); Diagnostic Test: Clinical functional assessment | |
| Cognitively unimpaired community dwelling people | Age matched cognitively unimpaired community dwelling people recruited via advertisements. Receives: Diagnostic Test: Timed Up-and-Go (TUG single-task); Diagnostic Test: Timed Up-and-Go dual-task (TUGdt); Diagnostic Test: Clinical functional assessment | |
| Cognitively unimpaired community dwelling people recruited for test-retest reliability analysis | Cognitively unimpaired individuals who agreed to participate in a retesting session. Receives: Diagnostic Test: Timed Up-and-Go (TUG single-task); Diagnostic Test: Timed Up-and-Go dual-task (TUGdt); Diagnostic Test: Clinical functional assessment | |
| Persons with cognitive impairment recruited for test-retest reliability analysis | Patients undergoing memory assessment at Uppsala University Hospital who agreed to participate in a retesting session and community dwelling older persons with self-reported subjective or mild cognitive impairment. This group includes patients with dementia, mild cognitive impairment and subjective cognitive impairment. Receives: Diagnostic Test: Timed Up-and-Go (TUG single-task); Diagnostic Test: Timed Up-and-Go dual-task (TUGdt); Diagnostic Test: Clinical functional assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to dementia
Diagnostic information for follow-ups and eventual dates of death, all participants' medical records will be reviewed by an experienced geriatrician. Participants will be classified as having "converted" after receiving a dementia diagnosis, and as "not converted" when a diagnosis of Subjective or Mild cognitive impairment had been confirmed after baseline, or when a reversion to normal cognition had been stated.
TUG and TUGdt parameters and composite indices will be examined for association with dementia incidence through Cox regression models with and without adjustment for possible confounding variables such as age, gender, and education. Possible occurrence of gender differences in associations between TUG parameters and dementia incidence will be examined. Optimal cut-off values for predictive TUG parameters (including composite indices) will be estimated. Also, sensitivity, specificity, c-statistics, and Youden's J index will be estimated.
Measured: Upp to 10 years
Secondary outcomes (1)
Level of cognitive functioning
Similarly to TUG and TUGdt parameters, association between different cognitive test results and dementia incidence through Cox regression models with and without adjustment for possible confounding variables such as age, gender, and education will be examined.
Measured: Upp to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start9 Apr 2015
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalarna University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University, The Swedish Research Council
- Responsible party
- Principal investigator, Prof. Anna Cristina Åberg, Dalarna University
- Investigators
- Anna Cristina Åberg, PhD, Principal investigator, Dalarna University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893524
- Sponsor's protocol ID
- HDA2021-00022
- Other IDs
- PUBCARE2016_122
- Acronym
- UDDGait™
- Status last verified
- Feb 2025
- First submitted
- 12 May 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahman HB, Giedraitis V, Cedervall Y, Lennhed B, Berglund L, McKee K, Kilander L, Rosendahl E, Ingelsson M, Aberg AC. Dual-Task Performance and Neurodegeneration: Correlations Between Timed Up-and-Go Dual-Task Test Outcomes and Alzheimer's Disease Cerebrospinal Fluid Biomarkers. J Alzheimers Dis. 2019;71(s1):S75-S83. doi: 10.3233/JAD-181265.
PubMed 31104024Cedervall Y, Stenberg AM, Ahman HB, Giedraitis V, Tinmark F, Berglund L, Halvorsen K, Ingelsson M, Rosendahl E, Aberg AC. Timed Up-and-Go Dual-Task Testing in the Assessment of Cognitive Function: A Mixed Methods Observational Study for Development of the UDDGait Protocol. Int J Environ Res Public Health. 2020 Mar 5;17(5):1715. doi: 10.3390/ijerph17051715.
PubMed 32150995Ahman HB, Cedervall Y, Kilander L, Giedraitis V, Berglund L, McKee KJ, Rosendahl E, Ingelsson M, Aberg AC. Dual-task tests discriminate between dementia, mild cognitive impairment, subjective cognitive impairment, and healthy controls - a cross-sectional cohort study. BMC Geriatr. 2020 Jul 29;20(1):258. doi: 10.1186/s12877-020-01645-1.
PubMed 32727472B Ahman H, Berglund L, Cedervall Y, Kilander L, Giedraitis V, J McKee K, Ingelsson M, Rosendahl E, Aberg AC. Dual-Task Tests Predict Conversion to Dementia-A Prospective Memory-Clinic-Based Cohort Study. Int J Environ Res Public Health. 2020 Nov 3;17(21):8129. doi: 10.3390/ijerph17218129.
PubMed 33153203Lofgren N, Giedraitis V, Halvorsen K, Rosendahl E, Aberg AC. The Timed Up and Go dual-task test's cognitive and motor outcomes show promising test-retest reliability in older adults with perceived memory impairment. Front Aging. 2026 Jan 8;6:1715756. doi: 10.3389/fragi.2025.1715756. eCollection 2025.
PubMed 41585362Lofgren N, Berglund L, Giedraitis V, Rosendahl E, Aberg AC. Can Turn Duration and Step Parameters During the Timed Up and Go Test With and Without a Dual-Task Discriminate Between Individuals With Different Cognitive Abilities? An Explorative Study. Assessment. 2026 Jan 22:10731911251410337. doi: 10.1177/10731911251410337. Online ahead of print.
PubMed 41572419Lofgren N, Berglund L, Giedraitis V, Halvorsen K, Rosendahl E, McKee KJ, Aberg AC. Extracted step parameters during the timed up and go test discriminate between groups with different levels of cognitive ability-a cross-sectional study. BMC Geriatr. 2025 Mar 17;25(1):182. doi: 10.1186/s12877-025-05828-6.
PubMed 40097949Aberg AC, Petersson JR, Giedraitis V, McKee KJ, Rosendahl E, Halvorsen K, Berglund L. Prediction of conversion to dementia disorders based on timed up and go dual-task test verbal and motor outcomes: a five-year prospective memory-clinic-based study. BMC Geriatr. 2023 Sep 2;23(1):535. doi: 10.1186/s12877-023-04262-w.
PubMed 37660032