Dementia Clinical Trial
— UDDGaitâ„¢Official title:
Uppsala-Dalarna Dementia and Gait Project
Verified date | May 2023 |
Source | Dalarna University |
Contact | Anna Cristina Åberg, PhD |
Phone | +4623778082 |
aab[@]du.se | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
UDDGaitâ„¢ 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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Dalarna University | Falun | Dalarna County |
Sweden | Uppsala University | Uppsala | Uppsala County |
Lead Sponsor | Collaborator |
---|---|
Dalarna University | The Swedish Research Council, Uppsala University |
Sweden,
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
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 |
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