Uppsala-Dalarna Dementia and Gait Project

Dementia Clinical Trial

— UDDGait™  

Official title:

Uppsala-Dalarna Dementia and Gait Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893524
• Other study ID #: HDA2021-00022
• Secondary ID: PUBCARE2016_122
• Status: Recruiting
• Start date: April 9, 2015
• Est. completion date: December 24, 2026

Study information

• Verified date: May 2023
• Source: Dalarna University
• Contact: Anna Cristina Åberg, PhD
• Phone: +4623778082
• Email: aab[@]du.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 24, 2026
• Est. primary completion date: December 24, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 37 Years to 94 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia of Alzheimer Type
• Dementia Senile
• Dementia, Mixed
• Mild Cognitive Impairment
• Subjective Cognitive Impairment

Intervention

Diagnostic Test:
• Timed Up-and-Go (TUG single-task)
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)
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 assessment
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.

Locations

Country	Name	City	State
Sweden	Dalarna University	Falun	Dalarna County
Sweden	Uppsala University	Uppsala	Uppsala County

Sponsors (3)

Lead Sponsor	Collaborator
Dalarna University	The Swedish Research Council, Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Ahman 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 — View Citation

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. — View Citation

B 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): — View Citation

Cedervall 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 classi?ed as having "converted" after receiving a dementia diagnosis, and as "not converted" when a diagnosis of Subjective or Mild cognitive impairment had been con?rmed 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.	Upp to 10 years
Secondary	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.	Upp to 10 years

External Links

•   Project summary in Dalarna University research project database
•   Project website