Clinical trial NCT05893524: Uppsala-Dalarna Dementia and Gait Project
Official title: Uppsala-Dalarna Dementia and Gait Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dementia
Dementia, Mixed
Dementia Senile
Dementia of Alzheimer Type
Mild Cognitive Impairment
Subjective Cognitive Impairment
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
Lead sponsor: Dalarna University
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: The Swedish Research Council
First posted: 2023-06-08
Enrollment: 550
Sex: ALL
Minimum age (years): 37
Maximum age (years): 94
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Conversion to dementia
timeFrame: Upp to 10 years
Secondary outcomes:
measure: Level of cognitive functioning
timeFrame: Upp to 10 years
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Dalarna University
state: Dalarna County
city: Uppsala
country: Sweden
facility: Uppsala University
state: Uppsala County
Study officials:
affiliation: Dalarna University
name: Anna Cristina Åberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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 cohort study. BMC Geriatr. 2020 Jul 29;20(1):258. doi: 10.1186/s12877-020-01645-1.
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):8129. doi: 10.3390/ijerph17218129.